Maxillary Sinus Grafting With Deproteinized Porcine or Bovine Bone Mineral.

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

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:

Study Overview

• Status: Completed
• Conditions: Histomorphometry
• Intervention / Treatment: Procedure: Maxillary sinus augmentation

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: bovine bone; Patients received maxillary sinus augmentation grafting with bovine bone mineral	Procedure: Maxillary sinus augmentation; Maxillary sinus grafting with 2 different xenogenic materials
Active Comparator: Porcine bone mineral; patients received maxillary sinus augmentation grafting with porcine bone mineral	Procedure: Maxillary sinus augmentation; Maxillary sinus grafting with 2 different xenogenic materials

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New bone formation	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.	3 year

Collaborators and Investigators

• Sponsor: Camlog Oral Reconstruction Foundation

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: March 14, 2023
• First Submitted That Met QC Criteria: March 26, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: March 26, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CamlogORF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No