Alveolar Ridge Preservation Using Different Bone Substitutes

Alveolar Ridge Enlargement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05812872
• Other study ID #: FDASU-RecIR092210
• Status: Completed
• Phase: Phase 3
• Start date: June 20, 2017
• Est. completion date: January 20, 2019

Study information

• Verified date: March 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 20, 2019
• Est. primary completion date: September 23, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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,

Related Conditions & MeSH terms

• Alveolar Ridge Enlargement
• Hypertrophy

Intervention

Drug:
• Toothgraft
Particulate dentin
• Allograft
Mineralized corticocancellous allograft
• Alloplast
Beta tri-calcuim phosphate

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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
Primary	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	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
Secondary	Radiographic assessment	Loss in bone width was calculated by measuring distance from buccal alveolar crest to palatal alveolar crest in millimeter.	3 months