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Clinical Trials/NCT05804253
NCT05804253
Completed
N/A

Clinical, Radiographic and Histological/Histomorphometric Analysis of Maxillary Sinus Grafting With Deproteinized Porcine or Bovine Bone Mineral: a Randomized Controlled Clinical Trial

Camlog Oral Reconstruction Foundation0 sites30 target enrollmentJanuary 1, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Histomorphometry
Sponsor
Camlog Oral Reconstruction Foundation
Enrollment
30
Primary Endpoint
New bone formation
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The present study aimed to compare the histomorphometrically evaluated new bone formation, the radiographically measured graft stability and the clinical implant outcome between maxillary sinuses grafted either with deproteinized porcine bone mineral (DPBM) or deproteinized bovine bone mineral (DBBM). Conclusions: From a clinical point of view, the present results demonstrate that DPBM provides for comparable bone formation and stable graft dimension and high implant success rates combined with healthy peri-implant condition:

Detailed Description

Materials and Methods: Thirty maxillary sinuses in 28 participants were initially included and randomly assigned to the test group (TG;DPBM: n=15) or the control group (CG,DBBM: n=15). After a healing period (6 months) bone core biopsies were axially retrieved in the molar site for histological/ histomorphometrical analysis of new bone formations. In addition, radiographically measured graft stability as well as the clinical implant outcome (implant survival/success/peri-implant health) were assessed at the 1-year and 3-year follow-up evaluations.

Registry
clinicaltrials.gov
Start Date
January 1, 2017
End Date
June 30, 2018
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Camlog Oral Reconstruction Foundation
Responsible Party
Principal Investigator
Principal Investigator

Krennmair Gerald

Univ.Prof.Dr.Dr

Camlog Oral Reconstruction Foundation

Eligibility Criteria

Inclusion Criteria

  • maxillary sinus atrophy in the need of sinus augmentation, 2 stage augmentation procedure

Exclusion Criteria

  • drug abuse, additional augmentation procedure, heavy smokers, bisphosphonate abuse

Outcomes

Primary Outcomes

New bone formation

Time Frame: 3 year

Bone trephine specimen retrieved at implant placement were histomorphometrically analyzed. With special interest % of new bone formation,% of residual graft and % of connective tissue were evaluated and compared between bovine and porcine mineral bone used for sinus grafting.

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