Ridge Preservation in Molar Sites Comparing Xenograft Versus Mineralized Freeze-dried Bone Allograft

Not Applicable

Completed

• Conditions: Alveolar Ridge Preservation
• Interventions: Procedure: Ridge preservation; Device: bone graft plus a collagen membrane

• Registration Number: NCT05107141
• Lead Sponsor: Universitat Internacional de Catalunya

Brief Summary

The objectives of the present investigation are; to compare the dimensional changes and the histological composition after the use of an allograft or xenograft and a resorbable membrane in ridge preservation in molar sites, to evaluate the influence of bone plates thickness on dimensional changes and the effectiveness of ridge preservation in limiting the need of sinus elevation.

Detailed Description

Twenty-four patients in need of maxillary or mandibular molar extraction and subsequent implant placement were included and randomly assigned to a group; allograft or xenograft, plus a collagen membrane. Cone Beam Computed Tomographies were obtained after molar extraction and after five months. A bone sample was harvested at the time of implant placement and analysed by histomorphometry.

Study Timeline

• Study Start: 2013-12-09
• Primary Completion: 2019-06-07
• Study Completion: 2019-06-07
• Status Verified: 2021-10
• Study First Submitted: 2021-10-10
• Study First Submitted QC: 2021-10-24
• Last Update Submitted: 2021-10-24
• Study First Posted: 2021-11-04
• Last Update Posted: 2021-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Adult patients, over 18 years old.
• In need of removal of a maxillary or mandibular molar first or second molar.
• The molars to be extracted had to be bordered by at least one tooth.
• The molars had to have a presence of > 2 mm of keratinized gingiva and three intact bony walls.
• A dehiscence on the fourth wall, if any, had to be equal or less than 2 mm in height.
• Only one extraction per patient was accepted.

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Exclusion Criteria

• Acute periodontal or periapical infection.
• Pregnancy or lactancy.
• Smokers of more than 10 cigarettes per day.
• Previous adverse reactions to the biomaterials used in the study.
• Metabolic diseases affecting the mechanism of bone remodelling.
• Medications or treatments taken in the last twelve months and known to affect bone "turnover".
• Patients with poor plaque control -more than 20% (O'Leary, Drake, Naylor, 1972).
• Patients with absence of periodontal health maintenance or postoperative recommendations compliance.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
xenograft and a collagen membrane	Ridge preservation	-
allograft and a collagen membrane	Ridge preservation	-
allograft and a collagen membrane	bone graft plus a collagen membrane	-
xenograft and a collagen membrane	bone graft plus a collagen membrane	-

Primary Outcome Measures

Name	Time	Method
Evaluation of ridge dimensional changes following ridge preservation in molar sites comparing the use of freeze dried bone allograft (FDBA) or xenograft (DBBM), and a resorbable membrane.	5 months	To evaluate dimensional changes, the initial (CBCT1) and 5 months (CBCT2) CBCT images were processed and superimposed with the use of a specialized software image Simplant® O\&O (Denstply Sirona, Charlotte, NC, USA).; Measurements were expressed in millimeters (mm) and percentages showing changes in ridge width at 1mm, 3mm and 5mm from the bone crest.; The height of the buccal, and lingual bone crest was assessed, as well as the heigh in the central are of the socket.

Secondary Outcome Measures

Name	Time	Method
Evaluate the histologic composition of the regenerated areas after the use of freeze dried bone allograft (FDBA) or xenograft (DBBM), and a resorbable membrane.	5 months	The histomorphometric analysis was performed by the use of a specific software image (Image J®, Image Processing and Analysis in Java) and the areas occupied by vital bone (VB), non-mineralized connective tissue (NMCT) and graft particles (GP) were evaluated. The analysis of each tissue volume was expressed in percentages (%)
Evaluate the influence of buccal or lingual bone thickness on bone ridge changes	5 months	The width of the buccal and lingual bone plates was evaluated, by CBCT analysis, at 1mm, 3mm and 5mm to evaluate any correlation with bone dimensional changes after 5 months.; Data was expressed in milimeters.