Alveolar Ridge Preservation Using Different Bone Substitutes

Phase 3

Completed

• Conditions: Alveolar Ridge Enlargement
• Interventions: Drug: Toothgraft; Drug: Allograft; Drug: Alloplast

• Registration Number: NCT05812872
• Lead Sponsor: Ain Shams University

Brief Summary

The primary objective of this study was to compare the efficacy of using allograft, autogenous tooth graft, and beta-tricalcium phosphate for alveolar ridge preservation (ARP) by examining the alveolar ridge height and width at baseline and 3 months after the ARP both clinically and radiographically. The secondary objective was to evaluate the quality of the newly formed bone using histomorphometric analysis.

Detailed Description

This randomized controlled clinical trial included thirty patients. ARP was performed using either Allograft (Allograft group n=10), Tooth graft (Toothgraft group n=10), and beta tri-calcium- phosphate (beta tri-calcium group n=10). Changes in alveolar ridge dimensions were evaluated clinically and radiographically using cone beam computed tomography at baseline and 3 months. Core bone biopsy samples were obtained 3 months post-extraction during implant placement for histomorphometric analysis.

Study Timeline

• Study Start: 2017-06-20
• Primary Completion: 2018-09-23
• Study Completion: 2019-01-20
• Study First Submitted: 2022-09-04
• Status Verified: 2023-03
• Study First Submitted QC: 2023-04-01
• Study First Posted: 2023-04-14
• Last Update Submitted: 2023-04-17
• Last Update Posted: 2023-04-19

Recruitment & Eligibility

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

Inclusion Criteria

1. seeking implant-based restorations after tooth extraction.
2. exhibited no evidence of any significant medical history, measured using Burket's Oral medicine health history questionnaire.
3. exhibited Type I and II sockets

Exclusion Criteria

1. nonsmokers.
2. Pregnant and breast-feeding females
3. patients with known contraindications to dental implant surgery (e.g., increased bleeding tendency, history of treatments such as radiotherapy,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alveolar ridge preservationwith tooth graft	Toothgraft	tooth graft
Alveolar ridge preservation with allograft	Allograft	Allograft
Alveolar ridge preservation with alloplast	Alloplast	Beta Tri-Calcium phosphate

Primary Outcome Measures

Name	Time	Method
Clinical assessment	3 months	Bone width loss was calculated by measuring alveolar ridge width buccopalatally in millimeter using a caliper clamp. The measurement was done perpendicular to the tangent of the dental arch at the mid-point of the extraction site approximately 4mm apical to the level of the marginal gingiva of the adjacent teeth.

Secondary Outcome Measures

Name	Time	Method
Radiographic assessment	3 months	Loss in bone width was calculated by measuring distance from buccal alveolar crest to palatal alveolar crest in millimeter.

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt