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Completed

NCT Number: NCT05812872

Alveolar Ridge Preservation Using Different Bone Substitutes

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.

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Key information

Conditions

Alveolar Ridge Enlargement

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ain Shams University

Cairo, 11751, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Toothgraft

Drug

Particulate dentin

Allograft

Drug

Mineralized corticocancellous allograft

Other names: Mineralized corticocancellous allograft

Alloplast

Drug

Beta tri-calcuim phosphate

Other names: Beta tri-calcuim phosphate

Primary outcomes

  1. Clinical assessment

    Time frame: 3 months

    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.

  2. Clinical assessment

    Time frame: 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 outcomes

  1. Radiographic assessment

    Time frame: 3 months

    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,

  2. Radiographic assessment

    Time frame: 3 months

    Loss in bone width was calculated by measuring distance from buccal alveolar crest to palatal alveolar crest in millimeter.

Other outcomes

  1. Histological

    Time frame: 3 months

    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

  2. Histomorphometric analysis

    Time frame: 3 months

    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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Apr 14, 2023
Registry last updated
Apr 19, 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.

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