Skip to main content
OpenTrials
Completed

NCT Number: NCT05804253

Maxillary Sinus Grafting With Deproteinized Porcine or Bovine Bone Mineral.

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:

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Histomorphometry

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Maxillary sinus augmentation

Procedure

Maxillary sinus grafting with 2 different xenogenic materials

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Camlog Oral Reconstruction Foundation

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 7, 2023
Registry last updated
Apr 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.