Alveolar Ridge Preservation Using Different Bone Substitutes

The Effect of Allograft, Toothgraft, Alloplast on Alveolar Ridge Preservation

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.

Study Overview

• Status: Completed
• Conditions: Alveolar Ridge Enlargement
• Intervention / Treatment: Drug: Toothgraft; Drug: Allograft; Drug: Alloplast

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11751
    • ain shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Alveolar ridge preservationwith tooth graft; tooth graft	Drug: Toothgraft; Particulate dentin
Active Comparator: Alveolar ridge preservation with allograft; Allograft	Drug: Allograft; Mineralized corticocancellous allograft; Other Names: Mineralized corticocancellous allograft
Active Comparator: Alveolar ridge preservation with alloplast; Beta Tri-Calcium phosphate	Drug: Alloplast; Beta tri-calcuim phosphate; Other Names: Beta tri-calcuim phosphate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical assessment	Measure bone height loss in millimeter at baseline and after 3 months was measured using periodontal probe from the stent margin to the alveolar ridge crest at six points. In addition, 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.	3 months
Clinical assessment	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic assessment	Measuring loss in bone height in millimeters between baseline and after 3 months. Loss in bone height was calculated by measuring the distance from the alveolar crest both buccally and palatally to a fixed anatomical landmark. In addition,	3 months
Radiographic assessment	Loss in bone width was calculated by measuring distance from buccal alveolar crest to palatal alveolar crest in millimeter.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histological	Masson trichrome special stain was used to detect the area percentage of immature collagen and mature collagen at magnification 20X. The immature collagen appeared blue in color while areas with mature collagen appeared reddish in color	3 months
Histomorphometric analysis	Photomicrographs of 3 microscopic fields of each MT stained section, were captured at the original magnification of 20X using a digital camera(Canon EOS 650D) mounted on a light microscope(BX60,Olympus , Japan). The images were analyzed for obtaining the area percentage of mature and immature collagen of the newly formed bone using image J (1.41aNIH, USA)software	3 months

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Yasmine A Fouad, Ph.D, ain shams University; Study Director: Suzan M Sarhan, Ph.D, ain shams University; Study Director: Hadeel M Gamal, Ph.D, ain shams University; Principal Investigator: Basma A Abdelrahman, Ph.D, ain shams University

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2017
• Primary Completion (Actual): September 23, 2018
• Study Completion (Actual): January 20, 2019

Study Registration Dates

• First Submitted: September 4, 2022
• First Submitted That Met QC Criteria: April 1, 2023
• First Posted (Actual): April 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Alveolar ridge preservation, Allograft, Toothgraft, Allopast
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hypertrophy
• Other Study ID Numbers: FDASU-RecIR092210

Drug and device information, study documents

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