NCT05812872

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2019

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2022

Completed
7 months until next milestone

First Posted

Study publicly available on registry

April 14, 2023

Completed
Last Updated

April 19, 2023

Status Verified

March 1, 2023

Enrollment Period

1.3 years

First QC Date

September 4, 2022

Last Update Submit

April 17, 2023

Conditions

Alveolar Ridge Enlargement

Keywords

Alveolar ridge preservation, Allograft, Toothgraft, Allopast

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Radiographic assessment

    3 months

  • Radiographic assessment

    3 months

Other Outcomes (2)

  • Histological

    3 months

  • Histomorphometric analysis

    3 months

Study Arms (3)

Alveolar ridge preservationwith tooth graft

ACTIVE COMPARATOR

tooth graft

Drug: Toothgraft

Alveolar ridge preservation with allograft

ACTIVE COMPARATOR

Allograft

Drug: Allograft

Alveolar ridge preservation with alloplast

ACTIVE COMPARATOR

Beta Tri-Calcium phosphate

Drug: Alloplast

Interventions

ToothgraftDRUG

Particulate dentin

Alveolar ridge preservationwith tooth graft
AllograftDRUG

Mineralized corticocancellous allograft

Also known as: Mineralized corticocancellous allograft
Alveolar ridge preservation with allograft
AlloplastDRUG

Beta tri-calcuim phosphate

Also known as: Beta tri-calcuim phosphate
Alveolar ridge preservation with alloplast

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, 11751, Egypt

Location

MeSH Terms

Interventions

Transplantation, Homologous

Intervention Hierarchy (Ancestors)

TransplantationSurgical Procedures, Operative

Study Officials

  • Yasmine A Fouad, Ph.D

    Ain Shams University

    PRINCIPAL INVESTIGATOR

  • Suzan M Sarhan, Ph.D

    Ain Shams University

    STUDY DIRECTOR

  • Hadeel M Gamal, Ph.D

    Ain Shams University

    STUDY DIRECTOR

  • Basma A Abdelrahman, Ph.D

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2022

First Posted

April 14, 2023

Study Start

June 20, 2017

Primary Completion

September 23, 2018

Study Completion

January 20, 2019

Last Updated

April 19, 2023

Record last verified: 2023-03

Locations

EG(1)