Treatment of Gingival Recession

Treatment of gingival recessiondefects with a coronallyadvanced flap and a xenogeneiccollagen matrix: a multicenterrandomized clinical trialJepsen K, Jepsen S, Zucchelli G, Stefanini M, de Sanctis M, Baldini N, Greven B,Heinz B, Wennstrom J, Cassel B, Vignoletti F, Sanz M. Treatment of gingivalrecession defects with a coronally advanced flap and a xenogeneic collagen matrix:a multicenter randomized clinical trial. J Clin Periodontol 2013; 40: 82–89. doi:10.1111/jcpe.12019.

AbstractAim: To evaluate the clinical outcomes of the use of a xenogeneic collagen matrix(CM) in combination with the coronally advanced flap (CAF) in the treatment oflocalized recession defects.Material & Methods: In a multicentre single-blinded, randomized, controlled,split-mouth trial, 90 recessions (Miller I, II) in 45 patients received eitherCAF + CM or CAF alone.Results: At 6 months, root coverage (primary outcome) was 75.29% for testand 72.66% for control defects (p = 0.169), with 36% of test and 31% of con-trol defects exhibiting complete coverage. The increase in mean width of kerati-nized tissue (KT) was higher in test (from 1.97 to 2.90 mm) than in controldefects (from 2.00 to 2.57 mm) (p = 0.036). Likewise, test sites had more gain ingingival thickness (GT) (0.59 mm) than control sites (0.34 mm) (p = 0.003).Larger (� 3 mm) recessions (n = 35 patients) treated with CM showed higherroot coverage (72.03% versus 66.16%, p = 0.043), as well as more gain in KTand GT.Conclusions: CAF + CM was not superior with regard to root coverage, butenhanced gingival thickness and width of keratinized tissue when compared withCAF alone. For the coverage of larger defects, CAF + CM was more effective.

Karin Jepsen1, Søren Jepsen1, Giov-anni Zucchelli2, Martina Stefanini2,

Massimo de Sanctis3, Nicola Baldini3,Bjorn Greven4, Bernd Heinz4, Jan

Wennstrom5, Bjorn Cassel5, FabioVignoletti6 and Mariano Sanz6

1Department of Periodontology, University of

Bonn, Bonn, Germany; 2Department of

Stomatology, Bologna University, Bologna,

Italy; 3Department of Periodontology, Siena

University, Siena, Italy; 4Private Practice,

Hamburg, Germany; 5Department of

Periodontology, University of Goteborg,

Goteborg, Sweden; 6Department of

Periodontology, University of Madrid, Madrid,

Spain

Key words: collagen (matrix); gingival

recession; keratinized tissue; root coverage;

tissue regeneration; xenograft

Accepted for publication 2 September 2012

Several surgical techniques and flapdesigns have been utilized to correctgingival recession defects by aug-menting gingival tissue dimensionsand hence, covering the exposed rootsurfaces (Pini-Prato et al. 1995). Pro-cedures using pedicle flaps, free softtissue grafts, combination of pedicle

flaps with grafts, barrier membranesor enamel matrix derivative are alleffective for this purpose as attestedby many studies (Cairo et al. 2008).More specifically, it was demon-strated that localized gingival reces-sions can be successfully treated witha coronally advanced flap (CAF),

Conflict of interest and source of

funding statementThe authors declare that they have noconflict of interest. This study wassupported by a research grant fromGeistlich Pharma AG.

© 2012 John Wiley & Sons A/S82

J Clin Periodontol 2013; 40: 82–89 doi: 10.1111/jcpe.12019

although the additional use of a con-nective tissue graft (CTG) or otherbiomaterials has shown to improvemean root coverage and the predict-ability of complete root coverage,when compared with CAF alone(Cairo et al. 2008, Cortellini et al.2009). A recent Cochrane systematicreview (Chambrone et al. 2010) con-cluded that the subepithelial CTGprocedure, the CAFs alone or asso-ciated with other biomaterials mayrender good results, although incases where root coverage and gainin keratinized tissue are expected,the use of CTG seems to be moreadequate. However, the wound atthe palatal donor site for harvestingthe CTG is frequently associatedwith discomfort for the patient(Cairo et al. 2008, Chambrone et al.2010).

To reduce patient discomfort,swelling and sometimes pain associ-ated with the wound at the palataldonor site when harvesting theCTG, alternatives are needed.A newly developed xenogeneic colla-gen matrix (CM) has been shown topromote regeneration of keratinizedgingiva around teeth and implantsin association with tissue augmenta-tion procedures (Sanz et al. 2009)and to improve early mucosalwound healing (Thoma et al. 2012).McGuire & Scheyer (2010) studiedthe safety and efficacy of thisCM + CAF for recession therapy in25 patients with bilateral MillerI and II recessions in a mono-centre,randomized, single-blind, split-mouth designed trial. Although val-ues of root coverage forCAF + CTG (99.3%) were higherthan for CAF + CM (88.5%), theyfound the procedure to be lessinvasive and time consuming withunlimited “off-the-shelf” supply ofgrafting material, and concludedthat it presents a viable alternativeto the CTG procedure.

There are, however, no dataavailable on the possible added ben-efit of the use of this CM in combi-nation with CAF when compared tothe standard CAF procedure for thetreatment of localized gingival reces-sions. It was, therefore, the primaryobjective of this randomized clinicaltrial to evaluate the effect of CM incombination with CAF treatmentcompared to CAF alone with respectto root coverage. As secondary

objectives, the amount of soft tissueaugmentation and patient-centredoutcomes were evaluated.

Material and methods

Study design and patients

This investigation was designed as amulticentre multinational, single-blind, split-mouth randomizedclinical trial (Fig. 1). The study pro-tocol was registered with Clinical-Trials.gov, Registration number:NCT00902876. A total of 45 patientswere consecutively selected to partic-ipate in the study from six differentclinics in Germany, Italy, Swedenand Spain and were treated withboth experimental and control surgi-cal procedures by expert periodon-tists. These patients were selectedaccording to the following inclusioncriteria:

• Presence of at least one localizedgingival recession in each side ofthe maxilla and/or mandible.

• The cemento–enamel junction(CEJ) was visible in the teeth forroot coverage procedures.

• All recessions were Class I or IIdefects (Miller 1985).

• The two defects within onepatient did not deviate more than2 mm in recession depth.

• All patients demonstrated ade-quate plaque control with a full-mouth plaque score � 20% andwith no clinical signs of activeperiodontal disease.

• All patients were at least 18 yearsof age.

The criteria for exclusion were:

• Patients smoking more than 10cigarettes per day.

• Patients with insulin-dependentdiabetes.

• Patients with a history of malig-nancy, radiotherapy, or chemo-therapy for malignancy.

• Patient pregnant or nursing dur-ing the past 5 months.

• Patients taking medications orhaving treatments with an effecton mucosal healing in general(e.g. steroids, large doses of anti-inflammatory drugs).

• Patients with a disease affectingconnective tissue metabolism.

• Patients allergic to collagen.

• Patients who participated in aclinical trial within the past6 months.

After a thorough explanation ofthe study procedures and their asso-ciated risks and benefits, participantssigned an informed consent in accor-dance with the Helsinki Declarationof 1975 as revised in 2000. The studyprotocol had been previouslyapproved by the respective ethicalcommittees for human subject trialsfrom the centres participating in thestudy. All female patients confirmednot to be pregnant and agreed forcontraception measures for at least6 months after surgery.

Clinical measurements

The primary endpoint of this trialwas the percentage of root coverage(RC) at 6 months. Secondary end-points were reductions in recessiondepth (REC), recession width (RW),complete root coverage (CRC), gainin thickness of gingival tissue (GT),gain in clinical attachment andincrease in width of keratinized tis-sue (KT).

At baseline, 3-month and6-month visits, one single-blindedexaminer per study site, differentfrom the surgical operator, recordedall the clinical outcome variables.

The following parameters wereassessed in millimetres with the useof a University of North Carolinaperiodontal probe (Hu-Friedy, Chi-cago, IL, USA):

• REC from the free gingival mar-gin to the cemento–enamel junc-tion.

• RW at the cemento–enamel junc-tion.

• KT from the free gingival marginto the mucogingival junction.

• GT with an injection needle(Sopira Carpule 0.3 9 16 mm,Heraeus Kulzer) and a siliconmarker, 1 mm below the gingivalmargin.

Pre-operative (Fig. 2) and follow-up photographs were taken at eachvisit. For patient-related factors, aquestionnaire as well as a visualanalogue scale (VAS) were given tothe patients to assess pain and dis-comfort during the initial healingphase.

© 2012 John Wiley & Sons A/S

Multicenter RCT of collagen matrix and CAF for root coverage 83

Selection of clinical centres and training

of investigators

Twelve expert periodontists in differ-ent clinical centres who were experi-enced operators in mucogingivalsurgery were selected to participatein the study. All participating inves-tigators were required to attendtraining and calibration meetings toreview the objectives of the studyand the protocol. Organizationalstrategies were discussed to optimizepatient accrual and retention anddata management. Preliminary clini-cal cases were discussed to standard-ize case selection, the measurementtechniques and the surgical proce-dures. Prior to starting the study,

each operator was video trained onthe surgical procedure in detail.

An external monitor frequentlyreassured on-site rules for the compi-lation of the data collection sheetsfor appropriate oversight to ensurethe validity of the data.

Treatment

Pre-surgical phase

As part of the screening phase forinclusion, all patients had a full-mouth periodontal examination withregistration of probing pocket depths(PD) and full-mouth bleeding scores(FMBS), Once the selected patientsagreed to participate in the study,

they were provided with customizedoral hygiene instructions, includingcontrol of traumatic tooth brushingtechniques as well as a dental pro-phylaxis and polishing.

Randomization, allocation conceal-ment and blinding

Selected patients were randomlyassigned to treatment by a centralregistrar using a computer-generatedrandomization list with random per-muted blocks (Fig. 1). The treatmentallocation was concealed to the ther-apist by opaque envelopes that wereopened upon completion of the com-mon part of the surgical treatment(flap elevation and root condition-ing). The clinical examiners remainedblinded to the treatment assignment.Blinding was broken after comple-tion of the statistical analysis.

Surgical procedures

The coronally advanced procedure(CAF) as described by De Sanctis &Zucchelli (2007) was used in thisinvestigation for both experimentaland control sites (see Data S1), onlythe order of sutures was reversed.

The exposed root surfaces wereconditioned with 24% EDTA for2 min. to remove the smear layer

Assessed for eligibility (n = 77)

Not meeting inclusion criteria (n = 18 )Declined to participate (n = 12) Other reasons (n = 2)

Analysed (n = 45 sites) Excluded from analysis (n = 0)

Lost to follow-up (n = 0)

Discontinued intervention (n = 0)

Allocated to intervention (n = 45 sites ) Received allocated intervention (n = 45)Did not receive allocated intervention (n = 0)

Lost to follow-up (n = 0)

Discontinued intervention (n = 0)

Allocated to intervention (n = 45 sites) Received allocated intervention (n = 45)Did not receive allocated intervention (n = 0)

Analysed (n = 45 sites) Excluded from analysis (n = 0)

Allocation

Analysis

Follow-Up

Randomized (n = 45)

Enrollment

♦

♦

♦

♦

♦

♦

♦

♦

♦

Fig. 1. Consort flow diagram of the study.

Fig. 2. Baseline. Gingival recessions on right and left canine scheduled to undergocoronally advanced flap procedures.


84 Jepsen et al.

from the dentine tubules (Blomlofet al. 1997) and thus improve coagu-lum adhesion to the root surface(Gamal 2011). After EDTA applica-tion, the root surface was rinsedwith saline for 60 s.

Following treatment allocation,the test material was applied in thetest sites. This material consisted ofa three-dimensional collagen matrix(Mucograft®; Geistlich Pharma AG,Wolhusen, Switzerland).

The collagen matrix was cut tothe size of the experimental defect,allowing a slight overlap and placedon the prepared recipient bed withthe smooth surface facing the oralcavity and the porous surface facingthe bone. Sharp edges were removedand the matrix was fixed to the rootsurface with resorbable sling sutures(Vicryl® 6-0, V492, P-3; Ethicon Inc.,Johnsson & Johnsson, NJ, USA).Complete moistening by blood andexudates allowed perfect adhesion ofthe matrix.

Subsequently, in both treatmentsites, the root surface was coveredwith the coronally advanced flap andsecured with sutures slightly coronallyof the CEJ by means of a slingsuture placed at the adjacent papil-lae, using non-irritating sutures (Pro-lene® 6-0, 8697, P-1; Ethicon Inc.).The vertical incisions were thenclosed by means of interruptedperiosteal 6-0 sutures starting at themost apical extension of the verticalrelease incisions. No periodontaldressing was applied.

Post-surgical protocol

Following surgery, patients wereinstructed to rinse twice daily withchlorhexidine mouth rinse (0.2%)for 1 month. Patients were instructedto avoid any mechanical trauma andtooth brushing for 4 weeks in thesurgical area. Anti-inflammatorytherapy and additional analgesicswere prescribed according to theindividual needs and the patientwas instructed to record daily theintensity of pain and the dose ofmedication in the patient question-naire.

The lateral sutures were removedafter 7 days if possible, and the slingsuture was removed after 14 days.Clinical photographs were takenafter cleaning and polishing to docu-ment the healing process (Fig. 3).Patients were recalled at 3 and

6 months after surgery for profes-sional oral hygiene procedures.

Data analysis

The study was conducted under inter-national quality standards (ISO14155)and the applicable national lawsto avoid bias including clinicalmonitoring, data management, GCPaudits and statistical analysis.

The main hypothesis was thatCAF combined with the xenogeneiccollagen matrix would result inimproved outcomes (superiority trial)(Cairo et al. 2012a, Tonetti &Palmer 2012) in terms of percentageof root coverage when comparedwith CAF alone was tested by one-sided paired Wilcoxon signed ranktest at the 5% level of significance(Sackett 2004). This procedure wasfurther used for an exploratory com-parison of the treatments withrespect to other endpoints. Paireddifferences were tested using Wilco-xon′s signed rank tests for pairedsamples.

For differences in primary out-comes of maxillary and mandibulardefects, a two-sided Mann–WhitneyU-test was performed.

To determine the associationbetween the primary end point per-centage of root coverage and base-line recession depth, Pearson′s andSpearman′s correlation coefficientswere calculated for test and controlsites separately.

Possible differences in the pri-mary outcome between study centreswere explored by the Kruskal–Wallistest.

The analysis was performed usingSAS version 9.2 (SAS Institute Inc.,Cary, NC, USA).

Sample size calculation

The calculation of patients to betreated was based on the primaryobjective to detect a true mean dif-ference of at least 10 percentagepoints between test and controltreatment for root coverage after6 months (McGuire & Scheyer2010). With a power of 80% andalpha = 0.05, based on superiorityconsiderations, a total of 35 patientswere required using a one-sided t-test for paired samples. The standarddeviation of the differences wasassumed to be 23 percentage points.To allow for non-parametric testing

and dropouts, 45 patients wererecruited.

Results

Forty-five patients (mean age:39.5 ± 13.8 years, 20–73 years, 17men, 28 women) were recruited andtreated between 2009 (February) and2010 (December). The number ofpatients per centre ranged from 3 to11. All patients were able to completethe follow-up examination after6 months.

Study teeth were maxillary cen-tral incisors (2), canines (40), pre-molars (24) and first molars (4) aswell as mandibular incisors (2),canines (4) and pre-molars (14),yielding 35 pairs of defects in themaxilla and 10 pairs in the mandible.Surgeries and post-operative seque-lae were uneventful and no patientin any group developed any signifi-cant complication.

Table 1 depicts the descriptivestatistics for all clinical parameters.Contra-lateral test and controldefects were well balanced at base-line. The results for the primary andsecondary clinical outcomes are pre-sented in Table 2. At 6 months, theprimary end point percentage of rootcoverage was on average 75.29% fortest sites and 72.66% for controlsites (p = 0.1695). For the secondaryoutcomes, the following results wereobtained: Mean recession depth at6 months was decreased to 0.87 mmfor test sites and 1.02 mm for con-trol sites. The split-mouth design ofthe study allowed calculation ofintra-patient differences (change fortest minus change for control),which translated to a significantmean difference of 0.27 mm in reces-sion depth changes from baseline to6 months (p = 0.0175) in favour ofthe test treatment. In contrast, forthe reductions in recession width, nosignificant differences between treat-ments were observed (p = 0.3925).At 6 months, 36% of test defectsand 31% of control defects showedcomplete root coverage.

The width of keratinized tissuecould be increased on average from1.97 to 2.90 mm for test sites andfrom 2.00 to 2.57 mm at controlsites. The difference in gain of0.37 mm was significant (p = 0.036).Likewise, for test defects, there was



a significantly higher increase in thethickness of gingival tissue (0.24 mm,p = 0.0035).

For the test treatment, no linearrelation could be found betweenbaseline recession depth and the pri-mary outcome % recession coverageat 6 months (Fig. 4). This was incontrast to the control treatment,where a negative linear relationshipmay be claimed (Pearson‘s correla-tion coefficient: �0.4193, p = 0.0041,Spearman′s correlation coefficient:�0.509, p = 0.0004) between baselinerecession and the primary outcomewith 95% confidence (Fig. 5). Fol-lowing CAF treatment, shallowdefects had a higher percentage ofrecession coverage than deeperdefects.

No significant centre effect withregard to the primary outcome couldbe determined (Kruskall–Wallis,p = 0.2450).

In a further analysis, patientswith shallow defects (REC < 3 mm)were excluded (Tables 3 and 4). Forthe remaining 35 patients, at6 months root coverage was higherfor test (72.03%) than for controlsites (66.16%) (p = 0.0430). Morekeratinized tissue was gained by testtreatment (0.54 mm, p = 0.0055).Likewise, for test defects, there was

a significantly higher increase in thethickness of gingival tissue(0.31 mm, p = 0.0030).

When comparing test and controltreatments, patient assessments ofpain or discomfort were equivalent(Table. 5). No differences could beobserved in visual analogue painscores at 7 days (2.32 versus 2.04)and 14 days (0.68 versus 0.59) postsurgery (Table. 6). The overall surgi-cal chair time for CAF was31 ± 14 min. versus 39 ± 14 min. forCAF + CM.

Discussion

To the best of our knowledge, this isthe first randomized clinical trialdesigned to evaluate the additionalbenefit of the use of a xenogeneiccollagen matrix in combination withthe CAF procedure for the treatmentof localized gingival recessions, whencompared with CAF alone. As theprimary outcome for efficacy, wemeasured the % of root coverage at6 months, resulting in the test group(CAF + CM) in a higher % RC of75.29% versus 72.66% in the controlgroup (CAF). This difference, how-ever, was not significant. Hence, thehypothesis of an enhanced outcomeby the use of the CM could not be

confirmed. However, the use of theCM resulted in significantly moregain in gingival thickness and widthof keratinized tissue.

The use of a xenogeneic collagenmatrix as an adjunct to the CAFprocedure might be relevant forseveral reasons; first because theCAF surgical procedure has demon-strated very good results in the treat-ment of localized gingival recessions,both in terms of root coverage aswell as in aesthetic outcomes (Pini-Prato et al. 1995). The demonstratedadditional effect shown in this RCT,therefore, may improve the predict-ability of this procedure in the treat-ment of Class I and II recessiondefects. When the CAF procedurehas been compared with the adjunc-tive use of an auto graft, recent sys-tematic reviews have clearly shownthe advantage of placing a connec-tive tissue graft under the flap (Cairoet al. 2008, Chambrone et al. 2010).In fact, when identifying which werethe significant factors, both patientand procedure- related, in the attain-ment of complete root coverage, anindividual patient data meta- analy-sis of randomized controlled clinicaltrials showed that the adjunctive useof a subepithelial connective tissuegraft achieved superior results thanthe coronally advanced flap alone(Chambrone et al. 2012). On theother hand, when assessing the inci-dence of adverse effects, such as dis-comfort with or without pain, theseevents were directly related to thedonor sites source of the connectivetissue grafts and a second woundarea (Cairo et al. 2008, 2012b,Chambrone et al. 2010).

Hence, an alternative for the con-nective tissue graft, which rendersbetter results than the CAF proce-dure, might be a good therapeuticoption in the treatment of ClassI and II recession defects.

Fig. 3. Six-month follow-up. Coronally advanced flap (CAF) + xenogeneic collagenmatrix (CM) and CAF alone were performed and complete root coverage wasachieved at treated teeth. Tooth 13 received CAF + CM.

Table 1. Clinical parameters at baseline (BL), 3 and 6 months

Mean (SD) Control (CAF) Test (CAF + CM)

BL 3M 6M BL 3M 6M

Recession depth (REC) 3.34 (1.00) 0.89 (1.11) 1.02 (1.08) 3.46 (0.90) 0.84 (0.95) 0.87 (0.94)Recession width (RW) 4.10 (0.93) 2.01 (1.72) 2.27 (1.75) 4.08 (0.89) 1.89 (1.84) 2.15 (1.86)Width of keratinized tissue (KT) 2.00 (1.22) 2.40 (0.93) 2.57 (1.15) 1.97 (1.13) 2.59 (1.28) 2.90 (1.29)Thickness of gingival tissue (GT) 0.89 (0.34) 1.17 (0.46) 1.23 (0.46) 0.89 (0.28) 1.37 (0.47) 1.48 (0.46)Clinical attachment level (CAL) 4.82 (1.09) 2.22 (1.33) 2.21 (1.25) 4.79 (1.01) 2.14 (1.15) 2.09 (1.14)Probing pocket depth (PPD) 1.48 (0.65) 1.33 (0.60) 1.19 (0.58) 1.33 (0.46) 1.30 (0.62) 1.22 (0.67)


86 Jepsen et al.

The collagen matrix utilized inthis clinical trial has shown clinicalefficacy for widening the width ofkeratinized tissue, both around teethand dental implants when used in anon-submerged healing environment(Sanz et al. 2009). Its use has alsobeen reported for the treatment ofrecession defects when used in a sub-merged environment in combinationwith the CAF procedure (McGuire& Scheyer 2010, Cardaropoli et al.2012). McGuire & Scheyer (2010) in

a split-mouth designed clinical trialcompared the use of CM + CAFversus the gold-standard treatment(CAF + CTG). Although the resultsin terms of aesthetic outcomes andpatient satisfaction were good inboth groups, the percentage of rootcoverage was significantly superiorfor the CAF + CTG procedure(99.3% versus 88.5%). These excel-lent results for the CTG procedureare, however, superior than themean %RC reported in systematic

reviews, ranging from 64.7% to97.3% and from 34.0% to 86.7%for CAF alone (Cairo et al. 2008,Chambrone et al. 2010). The % RCresult reported in the present clinicaltrial for the CM + CAF was 75.3%,which is within the range of the sci-entific evidence for the use of con-nective tissue grafts, althoughinferior to the mentioned compara-tive studies (McGuire & Scheyer2010, Cardaropoli et al. 2012).

One reason for this discrepancywas the fact that this study wasdesigned as a multicentre random-ized clinical trial employing six sur-geons in a variety of differentsettings, what might have influencedthe extent of the results, but alsohighlights its external validity andhence, the generalizability of theresults obtained. In the preparationof the study, the examiners had beentrained, but not calibrated withregard to an assessment of the intra-and inter-examiner reproducibility oftheir recordings. This is certainly aweakness of this study and it mayonly be speculated that any system-atic error would have been compen-sated to some extent by thesplit-mouth design of the study.Interestingly though, no centre effecton the treatment outcomes could bestatistically demonstrated.

Another factor could be the meanbaseline recession depth, which wassmaller in both studies when com-pared with this investigation.Although our data showed that forCAF alone, recession coverage cor-related inversely with initial recessiondepth, no such correlation was seenwith the use of CAF + CM, indicat-ing that deeper defects would benefitmore from the additional applicationof CM. Indeed, when in asubanalysis 10 patients with shallowrecessions (<3 mm) were excluded,

Table 2. Changes in clinical parameters between baseline (BL) and 3 and 6 months

Mean (SD) Control (CAF) Test (CAF + CM) Test/Control p-value

BL – 3M BL – 6M BL – 3M BL – 6M Changedifference BL – 6M

% Root coverage (RC) 76.44 (26.83) 72.66 (26.19) 76.11 (26.81) 75.29 (26.68) 2.63 (21.19) 0.1693% Defects with 100% coverage (CRC) 38 31 38 36 0.3870Recession depth (REC) reduction 2.46 (1.06) 2.32 (0.99) 2.61 (1.09) 2.59 (1.11) 0.27 (0.92) 0.0175Recession width (RW) reduction 2.09 (1.57) 1.84 (1.48) 2.19 (1.67) 1.91 (1.73) 0.07 (1.54) 0.3925Increase in width of keratinized tissue (KT) 0.40 (1.04) 0.57 (0.98) 0.62 (1.12) 0.93 (1.15) 0.37 (1.18) 0.0360Increase in thickness of gingival tissue (GT) 0.28 (0.53) 0.34 (0.55) 0.48 (0.46) 0.59 (0.44) 0.24 (0.63) 0.0035

Fig. 4. Scatterplot of % Root Coverage (RC) at 6 months versus Recession Depth(REC) at Baseline for Defects treated with coronally advanced flap (CAF) + xenoge-neic collagen matrix (CM).

Fig. 5. Scatterplot of % Root Coverage (RC) at 6 months versus Recession Depth(REC) at Baseline for Defects treated with coronally advanced flap (CAF) alone.



significantly better results withregard to % RC, gain in KT andGT were found for CAF + CM.

As alternative treatments to theuse of autogenous grafts, allogeneicmaterials have also been studied forthe treatment of recession defects.The most studied material, acellulardermal matrix (ADM), showed inthe meta-analyses a mean % RC forCAF + ADM between 50% and99% (Cairo et al. 2008, Chambroneet al. 2010). However, these studies

did not show a significant additionalbenefit over CAF alone in terms ofcomplete root coverage, recessionreduction or KT gain. These findingsare in contrast with those obtainedin this investigation, where a highergain of keratinized tissue was foundwhen CM + CAF was compared toCAF alone. Using CM + CAF, themean gain in width of keratinizedgingiva was 0.93 mm. These resultsare similar to those obtained in pre-vious studies (McGuire & Scheyer

2010, Cardaropoli et al. 2012),reporting a gain of 1.3 mm and1.2 mm respectively. In one of thesestudies (Cardaropoli et al. 2012), theincrease in gingival thickness wasmeasured, reporting a mean gain of1.0 mm at 12 months in the CMgroup, which is somewhat more thanthe mean gain of 0.6 mm reported inthis study at 6 months, but signifi-cantly higher than for CAF alone.This gingival thickness augmentationmight improve the long term predict-ability of this procedure, by dimin-ishing post-surgical relapse and thusproviding longer term stability.

There is no evidence from humanhistology available to demonstratethe quality of the healing followingthe application of CM. However,results from a recent animal experi-ment with recession-type defectsdemonstrated that the CM in con-junction with the CAF procedureattained significantly better regenera-tive outcomes than the CAF proce-dure alone. The healing in theCM + CAF group was characterizedby a shorter epithelial interphaseand a larger dimension of newcementum formation (Vignolettiet al. 2011).

Within the limitations of thisstudy, the following conclusions canbe drawn:

• CM + CAF was not superior toCAF in providing a consistentreduction of the baseline reces-sion.

• The shorter chair time could indi-cate the use of a CAF alonewhen this issue is of primaryimportance for the patient.

• If the therapeutic objectives arethe increase of gingival thicknessand gain of keratinized gingiva,

Table 3. Clinical parameters for patients (n = 35) with initial recession depth(REC) � 3 mm at baseline (BL) and 6 months

Mean (SD) Control (CAF) Test (CAF + CM)

BL 6M BL 6M

Recession depth (REC) 3.63 (0.90) 1.27 (1.09) 3.66 (0.84) 1.01 (0.99)Recession width (RW) 4.20 (0.99) 2.79 (1.56) 4.27 (0.82) 2.52 (1.82)Width of keratinized tissue (KT) 2.03 (1.24) 2.54 (1.22) 2.06 (1.22) 3.11 (1.35)Thickness of gingival tissue (GT) 0.91 (0.35) 1.27 (0.46) 0.87 (0.28) 1.54 (0.48)Clinical attachment level (CAL) 5.00 (1.11) 2.53 (1.18) 4.96 (0.93) 2.29 (1.15)Probing pocket depth (PPD) 1.37 (0.56) 1.26 (0.53) 1.30 (0.47) 1.27 (0.68)

Table 4. Changes in clinical parameters between baseline (BL) and 6 months for patients(n = 35) with initial recession depth (REC) � 3 mm

Mean (SD) Control (CAF) Test (CAF + CM) Test/Control

BL – 6M BL – 6M ChangedifferencesBL – 6M

p-value

% Root coverage (RC) 66.16 (25.7) 72.03 (26.85) 5.87 (19.25) 0.0430% Defects with 100%coverage (CRC)

17 29 12 0.1445

Recession depth (REC)reduction

2.36 (1.10) 2.64 (1.18) 0.29 (0.82) 0.0380

Recession width (RW)reduction

1.42 (1.31) 1.74(1.77) 0.32 (1.47) 0.1145

Increase in width ofkeratinized tissue (KT)

0.51 (1.00) 1.06 (1.22) 0.54 (1.18) 0.0055

Increase in thickness ofgingival tissue (GT)

0.36 (0.55) 0.67 (0.40) 0.31 (0.65) 0.0030

Table 5. Results of patient questionnaire for post-operative pain and discomfort (Question: “How was the postoperative course?”)

Day 7 (n = 45) Day 14 (n = 44)

Test only Controlonly

Tied Test only Controlonly

Tied

N % N % N % N % N % N %

Pain 1 2.2 0 0.0 44 97.8 2 4.6 2 4.6 40 90.9Swelling 0 0.0 2 4.4 43 95.6 1 2.3 1 2.3 42 95.5Unable to chew 0 0.0 0 0.0 45 100.0 1 2.3 1 2.3 42 95.5Bleeding 3 6.7 3 6.7 39 86.7 0 0.0 0 0.0 44 100.0Other 4 8.9 0 0.0 41 91.1 1 2.3 0 0.0 43 97.7

Test = collagen matrix + coronally advanced flap, control = coronally advanced flap.


88 Jepsen et al.

the use of CM under a CAFshould be considered.

• In recession defects � 3 mm, theCM + CAF could improverecession coverage and gingivalaugmentation compared to CAFalone.

Acknowledgements

The authors would like to thankMichael Mayer for his expert statis-tical analysis and Dr. WolfgangKleimeier for excellent study moni-toring.

References

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Supporting Information

Additional Supporting Informationmay be found in the online versionof this article:

Data S1. Methods.

Address:Karin JepsenDept. of Periodontology,Operative and Preventive DentistryUniversity of BonnWelschnonnenstr. 17, 53111 Bonn, GermanyE-mail: [email protected]

Clinical Relevance

Scientific rationale for the study:Recently, a new xenogeneic collagenmatrix has been introduced as a softtissue substitute and has been evalu-ated compared with the connective tis-sue graft. However, there are no dataavailable regarding a possible added

benefit when compared to the standardcoronally advanced flap procedure forthe treatment of recessions.Principal findings: The combinationof a new collagen matrix with thecoronally advanced flap yielded simi-lar recession coverage and improvedsoft tissue augmentation when com-

pared to coronally advanced flapalone.Practical implications: A new colla-gen matrix can enhance the out-comes of recession therapy with acoronally advanced flap, and maybe an option for the coverage oflarger defects.

Table 6. Results for pain evaluation byvisual analogue scale (VAS)

Visit Treatment N Mean SD

7 days Test 45 2.32 2.08Control 45 2.04 1.82

14 days Test 43 0.68 1.21Control 42 0.59 0.91

Test = collagen matrix + coronally advancedflap, control = coronally advanced flap.



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Treatment of Gingival Recession