77685854 Survival and Success Rates of Immediately and Early Loaded Implants

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Survival and Success Rates ofImmediately and Early Loaded Implants:12-Month Results From a MulticentricRandomized Clinical StudyTommaso Grandi, DDS1*Giovanna Garuti, DDS1

Paolo Guazzi, DDS2

Luciano Tarabini, DDS3

Andrea Forabosco MD1

Our objective was to compare survival and peri-implant bone levels of immediately

nonocclusally vs early loaded implants in partially edentulous patients up to 12 months after

implant placement. Eighty patients (inclusion criteria: general good health, good oral

hygiene, 3065 years old; exclusion criteria: head and neck irradiation/cancer, pregnancy,

uncontrolled diabetes, substance abuse, bruxism, lack of opposing occluding dentition,

smokers .10 cigarettes/day, need for bone augmentation procedures) were selected in 5

Italian study centers and randomized into 2 groups: 40 patients in the immediately loaded

group (minimal insertion torque 30 Ncm) and 40 patients in the early loaded group.

Immediately loaded implants were provided with nonoccluding temporary restorations. Final

restorations were provided 2 months later. Early loaded implants were provided with a

definitive restoration after 2 months. Peri-implant bone resorption was evaluated

radiographically with software (ImageJ 1.42). No dropout occurred. Both groups gradually

lost peri-implant bone. After 12 months, patients of both groups lost an average of 0.4 mm

of peri-implant bone. There were no statistically significant differences (evaluated with ttest)

between the 2 loading strategies for peri-implant bone level changes at 2 (P .6730), 6 (P

.6613) and 12 (P .5957) months or for survival rates (100% in both groups). If adequate

primary stability is achieved, immediate loading of dental implants can provide similar

success rates, survival rates, and peri-implant bone resorption as compared with early

loading, as evaluated in the present study.

Key Words: early loading, immediate loading, partial edentulism, dental implants

1 Department of Integrated Activities of Specialized Head-Neck Surgery, University of Modena and ReggioEmilia, Italy.2 Private practice, Modena, Italy.3 Private practice, Carpi (MO), Italy.* Corresponding author, e-mail: [email protected]: 10.1563/AAID-JOI-D-10-00149

Journal of Oral Implantology 239

RESEARCH


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INTRODUCTION

A

ccording to the Branemark

protocol,1 a stress-free heal-

ing period is an essential

prerequisite for controlled

implant integration. Osseoin-tegrated dental implant procedures have

traditionally followed a 2-stage protocol.2

This approach envisages the implant being

submerged and left to heal for a period of

34 months in mandibles and 68 months

in maxillae; this is to ensure protection

from bacterial infection and to minimize

loading forces and related movement

during the initial healing period. Following

a 46-month healing period, a second

surgical procedure is performed to expose

the implants.

In 1990, findings were published of the

first longitudinal clinical trial that suggest-

ed implants could be loaded immediately

or early in the mandibles of selected

patients.3 Several studies have revealed

that good clinical outcomes could be

achieved with 1-stage implants4 or 1-stage

protocols with 2-piece implant systems.5

Several authors have argued that im-

mediate loading is possible using fixed

superstructures6,7 or bar-retained overden-tures, thereby preventing implant move-

ment with a rigid splint. Chiapasco et al8

and Gatti et al9 demonstrated that the

success rates for immediately loaded

mandibular implants using U-shaped Dol-

der bars are similar to that obtained in

cases of delayed loading. Recent clinical7,8

and experimental10 results have encour-

aged a progressive shortening of the

healing period, and immediate loading

has been proposed.Nowadays, immediate and early load-

ing of dental implants are techniques that

are gradually gaining in popularity. Such

procedures are highly appreciated by the

patients, whose treatment period is dras-

tically reduced, and who can resume a

normal life with minimal discomfort.

A systematic Cochrane review evaluat-

ing the efficacy of immediately and early

loaded implants vs conventionally loaded

implants concluded that, in carefully se-

lected cases, such procedures can be

successful11; however, not all trials showed

predictably high success rates.12,13 This

suggests that, although such procedures

are likely to be technique sensitive, it ispossible to load oral implants immediately

in selected cases.

A recent split-mouth designed clinical

study revealed significantly higher failure

rates in single, immediately loaded im-

plants than in single, conventionally load-

ed implants.13 Failed implants had been

inserted with 20 Ncm insertion torque, and

the authors demonstrated a strong corre-

lation between implant failure and inser-

tion torque.These and other studies support the

hypothesis that primary implant stability

and lack of micromovement at the bone-

implant interface is a determining factor in

achieving high success rates.

Micromovement at the bone-implant

interface is deleterious in terms of bone

healing, but it has been shown that

micromovement of between approximate-

ly 30 and 150 lm did not negatively affect

bone healing.14

It is possible to splintimplants together in order to reduce

micromovement and obtain cross-arch

stabilization.

To reduce the risk of failure in cases of

immediately loaded implants, various clin-

ical protocols have been proposed, includ-

ing underpreparation techniques at the

implant site to achieve high primary

stability15; the use of temporary, non-

occlusal restoration during the first 2

months of healing16

; and progressiveloading of the prosthesis.

The purpose of this multicenter ran-

domized clinical study was to compare the

survival and success rates of immediately

and early loaded implants in partially

edentulous patients. This paper presents

preliminary 12-month results. Immediate

loading was defined as the seating of

provisional restoration immediately after

240 Vol. XXXVIII/No. Three/ 2012

Immediately and Early Loaded Implants


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implant placement that would not be in

occlusal contact for about 2 months; early

loading was defined as loading of both

mandibular and maxillary implants subse-

quent to a 2-month healing period.

MATERIALS AND METHODS

For this study 80 partially dentate patients

were selected, who required 2 implants for

rehabilitation. In 1 patient, randomized to

the immediately loaded group, 3 implants

were placed. All patients were followed up

for 12 months. The study protocol was

explained in detail to each patient, and

informed written consent was obtained.

For patients with multiple edentulous

areas to be restored, the operator was free

at the screening visit to select 1 area to be

included in the trial. Patients were ran-

domized into 2 groups: the test group

(immediate loading) and the control group

(early loading). Patient recruitment, im-

plant placement, and follow-up were

carried out by a single expert operator in

5 study centers in Italy.

Patient selection

Patient inclusion was based on the follow-ing criteria:

1. Age between 30 and 65 years

2. Good oral hygiene

3. Good general health

4. Signed, informed consent

Patients were excluded from the study

if any one of the following criteria was

present:

1. Patient had undergone in the past 12months radiation therapy to the headand neck area

2. Uncontrolled diabetes

3. Pregnancy

4. Poor oral hygiene and motivation

5. Substance and alcohol abuse

6. Treatment with bisphosphonate

drugs

7. Psychiatric problems

8. Lack of opposing occluding dentition

at the proposed implant site

9. Severe bruxism or clenching

10. Active infection or severe inflamma-

tion at the proposed implant site

11. Need for bone augmentation proce-

dures including sinus augmentation

12. Smoking more than 10 cigarettes aday

During the first visit, the patients oral

hygiene and periodontal health were

assessed. In particular, periodontal screen-

ing and recording (PSR) was performed.

Patients with a PSR reading of up to 3 were

treated by a dental hygienist and reviewed

after 30 days for a plaque index evalua-

tion17. Where the plaque index was up to

2, patients were excluded from the study.Immediate postextractive implants

were included in the study if the implants

could be placed with a final insertion

torque of 30 Ncm. In such cases, the

osteotomy did not follow the tooth socket

but an ideal prosthetically driven position.

The gap between one of the bone walls

and the surface of the implant did not

exceed 1.5 mm.

Patients enrolled were randomly as-

signed to 1 of the 2 treatment groups.Surgical protocol

Local anesthesia was obtained using arti-

caine with adrenaline 1:100 000 (Septan-

est, Septodont, Saint-Maur-des-Fosses, Ce-

dex, France). Implants were placed using a

flapless or flapped technique. Full-thick-

ness crestal flaps were elevated with a

slight extension to reduce patient discom-

fort to a minimum. If teeth were to be

extracted, extractions were performed asatraumatically as possible to preserve the

buccal alveolar bone using periotomes and

small levers. Extraction sockets were care-

fully cleaned of any granulation tissue.

Implant sites were prepared according to

the manufacturers instructions. Implants

were placed at the crestal level in the

healed edentulous ridge.

During the initial osteotomy, bone


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quality was assessed at the preparatory

site on the basis of resistance to drilling

with a 2-mm twist drill. Bone was classified

as either D1, D2, D3, or D4 and respective

values were recorded.18 In this study,

tapered self-tapping implants were used

(JDEvolution, JDentalCare, Modena, Italy).Implants were placed using a 1-stage

(nonsubmerged) surgical protocol. The

diameters of implants used were 4.3 and

5 mm; their lengths were 10, 11.5, and 13

mm (see Table 1). The choice of implant

diameter and length was left to the

surgeons discretion. Final insertion torque

was measured with a calibrated torque

wrench (JDTorque, JDentalCare, Modena,

Italy) and its value was recorded.

During the protocol formulation phaseit was decided that implants should attain

insertion torque of at least 20 Ncm to be

included in the study. Implants that

attained an insertion torque of less than

30 Ncm were excluded from the immedi-

ate loading group.

Interrupted sutures were placed using a

synthetic monofilament thread (Vycril,

Ethicon, Johnson & Johnson, Cornelia, Ga)

and were removed after 10 days.

Postoperative instructions

All patients were instructed to rinse their

mouth with 0.2% chlorhexidine mouth

rinse twice a day, commencing 3 days

prior to the intervention and thereafter for

a 2-week period. All patients were asked to

adopt a diet based on soft food for 48

hours postoperatively and to avoid chew-

ing hard food at the rehabilitated sites for

a 6-week period. They were recommended

to brush implant sites with particular

delicacy. Antibiotics and analgesics were

administered to all patients: amoxicillin 2 g

1 hour prior to surgery and 1 g bid for 6

days, and ibuprofen 400 mg bid for 4 days.

Patients allergic to penicillin were given

clarithromycin 500 mg 1 hour before theintervention and 250 mg bid for 6 days.

Restorative protocol

In the test group, titanium abutments

were placed immediately following the

surgical phase. A provisional restoration,

manufactured prior to the intervention,

was relined in situ with acrylic resin,

refined, and polished (Figures 16). The

absence of centric or eccentric contacts

was verified by interposing 200-lm artic-

ulating paper.

In the control group, a healing abut-

ment was connected to the implants.

The definitive prostheses were deliv-

ered 2 months after surgery. An impres-

sion with pickup impression copings was

made using addition silicone (Elite Implant

Impression Material; Zhermack, Badia Pole-

sine, Italy). For both groups, definitive

restorations were cemented with full

occlusal contacts (Figures 79).

Follow-up

Patients were recalled at 2 weeks and at 2,

6, and 12 months after surgery. Periapical

radiographs were performed prior and

subsequently to implant insertion and

postoperatively at 2, 6, and 12 months.

Criteria used in this study to assess the

TABLE 2

Patient distribution in the various centers

CenterImmediate

LoadingEarly

Loading

Modena 1 13 12

Modena 2 8 8

Bologna 2 5 5

Bologna 2 9 9Rimini 6 6

Totals 41 40

TABLE 1

Implant length and diameter

ImmediateLoading

EarlyLoading

Length (mm)

10 7 7

11.5 13 14

13 21 19Diameter (mm)

4.3 29 27

5 12 13




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outcome were peri-implant marginal bone

level; implant failure (any mobility or

infection that required implant removal);

and biologic or prosthetic complications.

Changes in peri-implant marginal bone

level were evaluated on intraoral radio-

graphs performed using paralleling tech-

nique. Periapical X rays were taken at

implant placement and thereafter at 2, 6,

and 1 2 m ont hs . Radiogr aphs w er e

scanned, digitized in JPG format, convert-

ed to TIFF format with a 600-dpi resolu-

tion, and stored in a personal computer.

The peri-implant marginal bone levels

were measured using Image J 1.42 soft-

ware (National Institute of Mental Health,

Rockville, Md). Each image was calibrated

twice, the first time using the known

length of the radiographs side (40 3 30

mm), the second time using the known

length of the fixture. To facilitate measure-

ment and fix the major axis in a vertical

FIGURES 15. FIGURE 1. Preoperative radiograph in a patient randomized to the immediately loadedgroup. FIGURE 2. Preoperative clinical view after the removal of the prosthesis. FIGURE 3. Afteratraumatic extractions of teeth, 3 implants were placed with flapless surgery according with theprosthetic requirements. FIGURE 4. The provisional restoration manufactured prior to the interventionwas relined with acrylic resin directly in the mouth. FIGURE 5. Clinical view of the provisional restorationrefined, polished, and cemented.


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direction, the images were rotated slightly

using the software program. Where nec-

essary, contrast between bone and im-

plant was increased with an image-en-

hancement procedure.

Readings of mesial and distal bone

levels adjacent to each implant were made

to the nearest 0.01 mm. The vertical

distance was measured between the cor-

onal margin of the implant collar (taken asthe reference point) and the most coronal

bone-to-implant contact.

An increase in the vertical distance

between the reference point and the most

coronal bone-to-implant contact for con-

secutive radiographs was considered in-

dicative of peri-implant marginal bone

resorption. Bone loss was calculated by

clinicians at each follow-up visit for each

implant, any variations from the baseline

values being recorded.

Criteria applied to gauge the successful

outcome of each implant were the ab-

sence of:

1. clinically detectable mobility

2. peri-implant radiolucency

3. implant infection

4. pain, paresthesia, or neuropathies5. crestal bone loss in excess of 1.5 mm

by the end of the first year of fun-

ctional loading

RESULTS

All data were analyzed in compliance with

a preestablished plan, the patient being

the statistical unit of analysis. The data

FIGURES 69. FIGURE 6. Intraoral radiograph made immediately after surgery. FIGURE 7. Buccal view of thedefinitive metal-ceramic restoration placed after 2 months. FIGURE 8. Intraoral radiograph at placementof the definitive restoration. FIGURE 9. Intraoral radiograph after 12 months.




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were analyzed by a biostatistician with

expertise in dentistry. The group to which

patients had been assigned was undis-

closed. All statistical comparisons were

carried out to a .05 level of significance.

This trial initially selected 88 patients,

but only 80 were included, 8 patientsbeing excluded on the grounds of insuffi-

cient oral hygiene. All patients enrolled in

the trial agreed to participate and signed

the consent form. They were randomized

into 2 groups: 40 to the test group and 40

to the control group. All patients were

treated in compliance with the trial proto-

col and no patients dropped out of the

study. All implants were successfully seat-

ed with a torque of more than 30 Ncm.

The follow-up study focused on theperiod between implant placement and 12

months thereafter. Patient distribution

among the various centers is shown in

Table 2.

Chief patient characteristics are pre-

sented in Table 3. Patients were generally

healthy, though 3 patients suffered from

diabetes. One of these was included in the

test group, the other 2 in the control

group.

Eighty-one implants were placed in theimmediately loaded group and eighty in

the early loaded group. The lengths and

diameters of the inserted implants are

presented in Table 1, whereas the bone

quality and the insertion torque are given

in Table 4.

In the test group, 62 implants were

placed in the lower jaw and 19 in the

upper jaw. In the control group, 58

implants were placed in the lower jaw and

22 in the upper jaw. Insertion torque

values varied from 30 to 100 Ncm in the

control group and from 55 to 95 Ncm in

the test group. The mean values were

58.93 and 77.06 respectively.

As can be seen, the 2 study groupswere comparable at baseline. Marginal

peri-implant bone loss was statistically

significant in both groups (P .001) at 2, 6,

and 12 months (Table 5). Measurements

from postoperative radiographs were ana-

lyzed with t test in order to verify any

differences between test and control

group at baseline: there were no signifi-

cant baseline imbalances between the 2

groups (P .1322).

After 2 months, patients in the imme-diately loaded group lost an average of

0.214 mm peri-implant bone, compared

with 0.249 mm for those in the early

loaded group (Table 5). After 6 months,

patients in the immediately loaded group

lost an average of 0.382 mm of peri-

implant bone, compared with 0.324 mm

for those in the early loaded group (Table

5). After 12 months, patients in the

immediately loaded group lost an average

of 0.421 mm of peri-implant bone, com-pared with 0.467 mm for those in the early

loaded group. There were no statistically

significant differences between the 2

loading strategies for peri-implant bone

level changes at 2 (P .6730), 6 (P .6613),

and 12 (P .5957) months. Mean and

standard deviation for bone level changes

are given in Table 5.

No implant failed within a 12-month

TABLE 3

Characteristics of patients

Test Group (Immediate Loading) Control Group (Early Loading)

Patients 40 40

Males 13 18

Females 27 22

Number of implants 81 80

Mean age at implant insertion 51.8 55.3Age range 3965 4365

Smokers (less than 10 cigarettes/d) 12 10

Diabetes 1 2


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period. No surgical or prosthetic compli-

cations were observed in any of the

patients. All treated patients were account-

ed for without exception.

DISCUSSION

The aim of this study was to compare

survival and peri-implant bone resorption

of immediate nonocclusal vs early loading

implants in partially edentulous patients

up to 12 months after placement.

The clinical success of dental implant

therapy is based on the anchorage in the

bone tissue of the implants endosseous

component. Osseointegration is a complex

biological phenomenon determined by a

series of events such as angiogenesis,

recruitment and migration of osteogenic

cells to the implant, and bone-matrix

deposition. It has been demonstrated that

the presence of movement at the implant-

bone interface can lead to the formation of

a soft-tissue interface that encapsulates

the implant, causing its failure.19

To minimize the risk of soft-tissue

encapsulation, it has been recommended

that the implants should be kept load free

by submerging them during the healing

period.2 This approach presupposed a 2-

phase technique: in this way implant sites

are preserved from infection during the

bone-healing phase. Clearly, the traditionalapproach requires longer treatment peri-

TABLE 5

Mean radiographic peri-implant bone resorption in the 2 groups at different times

Baseline 2 mo 6 mo 12 mo

Immediate loading mean (SD) (mm) 0.000 (0.028) 0.214 (0.057) 0.382 (0.025) 0.421 (0.009)

Early loading mean (SD) (mm) 0.097 (0.026) 0.249 (0.025) 0.324 (0.028) 0.467 (0.012)

P value (t test) .132 .6730 .6613 .5957

TABLE 4

Bone density and insertion torque

Immediate Loading Early Loading Total

Tactile bone density

D1 4 1 5

D2 59 64 123

D3 18 15 33

D4 0 0 0Total 81 80 161

Insertion torque

30 0 2 2

35 0 5 5

40 0 3 3

45 0 4 4

50 0 16 16

55 3 19 22

60 6 10 16

65 4 0 4

70 12 7 19

75 15 3 18

80 20 0 20

85 8 3 1190 9 3 12

95 4 1 5

100 0 4 4

Total 81 80 161




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ods (46 months) as well as a second

surgical intervention to expose the im-

plants.

By contrast, immediate or early loading

of the implants entails several advantages

for the patient. Immediate loading proto-

cols are aimed at simplifying implant

therapy, reducing costs, and eliminatingthe use of removable prostheses. This is

achieved by reducing the number of

surgical interventions and visits required

prior to delivery of the final prosthesis.

Henry and Rosenberg suggest that

both the clinical performance and the

prognosis of immediate loading compare

favorably with traditional methods.20 Oth-

er clinical trials have shown that immedi-

ately and early loaded implants achieve

high success rates.21

Immediate and early loading increased

stress during bone healing. Movement at

the bone-implant interface promotes the

transformation of mesenchymal cells into

fibroblast and causes fibrous encapsula-

tion at the implant site. Bone tissue

trophicity can be maintained with me-

chanical stimulation; conversely, the bone

segment became atrophic where mechan-

ical loading did not take place. Thus, the

mechanical stimulation of bone tissue, asin the case of immediate loading, can also

activate mesenchymal cells and promote

the recruitment of the osteogenic cells.22 It

has been observed that small strains not

only improve bone-fracture healing, but

may be essential to the healing process

itself, whereas the absence of strain is

known to impair the bone-healing pro-

cess.23

The formation of new bone tissue is

most intense at 2 months after implantplacement, when more than 30% of

osteons are in an active remodeling state.

Submitting the bone to loading stimulus

while it is undergoing its maximum

remodeling activity may well help the

bone to adapt more readily to loading

stress rather than when remodeling activ-

ity has abated, as would be the case where

a dental implant remains unloaded for 3 to

6 months.24 Microstrain may thus exert a

benign influence during the healing period

subsequent to implant placement. Osteo-

porosis research confirms that it leads to

increased bone density,25 and similar

findings have been reported in dental

implantology.26

Immediate and early loading proce-dures can be successful only when micro-

movement at the bone-implant interface

remains below a certain threshold during

the healing phase. Micromovement is

known to cause fibrous encapsulation of

the implant only if it is above 150 lm.27

The results of this trial are encouraging:

none of the implants were lost over a 12-

month period. It should be emphasized

that the immediately loaded implants were

not submitted to direct occlusion for 2months, although they were used during

chewing. Other clinical trials confirm the

absence of significant clinical differences in

the survival of immediately and early

loaded implants.28

It is not early or immediate loading that

prevents osseointegration; rather, excess

micromovement during the healing phase

interferes with the process of bone repair.

In this study protocol, micromovement

was reduced to a minimum by splintingimplants together.

All implants achieved high primary

stability at placement, and this appears

to be the key factor in obtaining the high

survival and success rates.

This study evaluated survival rates up

to 12 months from implant placement.

This follow-up period is brief, but takes

account of the fact that implant failure due

to mechanical overloading occurs early on

in the healing period.29

Marginal bone losswas in the range of 0.420.46 mm and was

identical for both study groups at 12

months.

lt can be concluded that immediate

loading of dental implants can be success-

ful if clinical guidelines are adhered to.

These include underpreparation of the

implant site, particularly where the bone

is soft; the use of active implants to


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achieve high primary stability; the achieve-

ment of high insertion torques (.30 Ncm);

and close control of loading. Some authors

also advocate the use of new implant

surfaces to reduce healing time.30 Other

authors report that their trials selected

patients so as to exclude risk factors from

mechanical overloading (eg, bruxism, oc-clusal instability).

To the best of the authors knowledge,

only 1 published randomized clinical trial

(RCT) has compared immediate loading

with early loading in partially edentulous

patients.28 However, very little bone-level

data is available. A recent Cochrane

review11 was able to include only 2

RCTs15,31 in a meta-analysis comparing

bone-level changes in patients with imme-

diate vs conventionally loaded implants.

CONCLUSIONS

If adequate primary stability is achieved,

immediate loading of dental implants can

provide similar success rates, survival rates.

and peri-implant bone resorption as com-

pared with early loading. Treatment goals

were achieved with both of the loading

protocols used; however, immediate non-

occlusal loading achieved these goalsfaster and with higher patient satisfaction.

ABBREVIATIONS

PSR: periodontal screening and recording

RCT: randomized clinical trial

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