Alveolar Ridge Preservation Using Different Bone Substitutes

April 17, 2023 updated by: Ain Shams University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11751
        • Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 months
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.
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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,
3 months
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.
3 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
3 months
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ain Shams University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 20, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 23, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 20, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 4, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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