Maxillary Sinus Grafting With Deproteinized Porcine or Bovine Bone Mineral.

Not Applicable

Completed

• Conditions: Histomorphometry
• Interventions: Procedure: Maxillary sinus augmentation

• Registration Number: NCT05804253
• Lead Sponsor: Camlog Oral Reconstruction Foundation

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.

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2018-06-30
• Study Completion: 2018-06-30
• Status Verified: 2023-03
• Study First Submitted: 2023-03-14
• Study First Submitted QC: 2023-03-26
• Last Update Submitted: 2023-03-26
• Study First Posted: 2023-04-07
• Last Update Posted: 2023-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bovine bone	Maxillary sinus augmentation	Patients received maxillary sinus augmentation grafting with bovine bone mineral
Porcine bone mineral	Maxillary sinus augmentation	patients received maxillary sinus augmentation grafting with porcine bone mineral

Primary Outcome Measures

Name	Time	Method
New bone formation	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.