Maxillary Sinus Grafting With Deproteinized Porcine or Bovine Bone Mineral.

Sponsor

Camlog Oral Reconstruction Foundation (Other)

Overall Status

Completed

CT.gov ID

NCT05804253

Collaborator

(none)

Enrollment

Arms

17.9

Actual Duration (Months)

Study Details

Study Description

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:

Condition or Disease	Intervention/Treatment	Phase
Histomorphometry	Procedure: Maxillary sinus augmentation	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

randomized clinical trial.randomized clinical trial.

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Jun 30, 2018

Actual Study Completion Date :

Jun 30, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Camlog Oral Reconstruction Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Krennmair Gerald, Univ.Prof.Dr.Dr, Camlog Oral Reconstruction Foundation

ClinicalTrials.gov Identifier:

NCT05804253

Other Study ID Numbers:

CamlogORF

First Posted:

Apr 7, 2023

Last Update Posted:

Apr 7, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 7, 2023