Submerged or non-submerged healing of endosseous implants to be used in the rehabilitation of partially dentate patients - A multicenter, randomized controlled clinical trial

Objective: To evaluate bone-level alterations that occurred at implants of the Astra Tech(R) System that were placed in the load carrying, posterior parts of the dentition using either a submerged (two-stage) or a non-submerged (one-stage) installation protocol. Material and Methods: Eighty-four patients that required 115 fixed partial dentures (FPDs or cases) entered the prospective study. All subjects were assigned one patient and greater than or equal toone case numbers. For the randomization of cases, a custom-made program based on balanced random permuted blocks was utilized. The cases were assigned to two treatment groups, namely one-stage installation procedure, non-submerged technique (group A) and two-stage installation procedure, submerged technique (group B). Several subjects contributed with cases to both groups A and B. Periodontal, endodontal and open caries lesions were treated prior to implant installation. All patients received careful oral hygiene instruction and training in self-performed plaque control measures. The surgical technique used for fixture installation followed the outline described in the manual for the Astra Tech(R) System. The FPDs were placed 3 months (mandible) and 6 months (maxilla) following implant installation. Immediately following FPD placement, a baseline examination was performed that included assessment of plaque, soft-tissue inflammation and bone level. Clinicians who were otherwise not involved in the study performed the radiographic measurements. Clinical and radiographical examinations were repeated once a year after the baseline examination. Data analysis: The primary outcome variable was the change in the bone level at the implants from the time of placement of the bridge (FPD) to the 1- and 2-year reexaminations. Fisher's permutation test was used to test if differences existed between groups A and B, and between patients (men/women, smokers/non-smokers, age), sites (maxilla/mandible) and implants (length, diameter). Pitman's test was used to study correlations between bone shape and quality data and different radiographic bone-level data. Results: It was demonstrated that tissue healing following implant installation appeared to be independent of the surgical protocol, i.e. whether the marginal portions of the implants during surgery were fully or only partly submerged under the ridge mucosa. Thus, (i) in both treatment groups the number of implants that failed to osseointegrate (early failures) was small (<2%); (ii) at the end of the recommended periods of bone healing prior to loading, - in both groups, maxilla=6 months and mandible=3 months - the level of the marginal bone was close to the coronal rim of the fixture; group A: 1.54+/-0.92 mm, group B: 1.31+/-0.77 mm. The current study also demonstrated that irrespective of surgical protocol (two-stage, one-stage), implants supporting the FPDs exhibited only small amount of radiographic bone loss during the first year of function (group A: 0.02+/-038 mm, group B: 0.17+/-0.64 mm). Moreover, during the second year of function, the amount of additional bone loss that occurred in the two treatment groups was close to zero. Conclusion: Periimplant bone-level change during function seemed to be unrelated to whether initial soft- and hard-tissue healing following implant installation had occurred under submerged or non-submerged conditions.