Alveolar Ridge Preservation Using a Composite Graft Plug: Radiographic and Clinical Assessment

September 27, 2024 updated by: Arwa Abubakr Badahdah, King Abdulaziz University

The goal of this clinical trial is to determine whether a graft material introduced recently (test) to be used in extraction sockets is as good as a previously known graft material (control) in adults undergoing tooth extraction of a single-rooted tooth.

The main question it aims to answer is:

Is this graft material able to maintain good bone volume and composition after extraction?

Researchers will compare this new graft to a well-studied graft material.

Participants will be randomly assigned to one of the groups and will receive the allocated graft after tooth extraction. The dimension of the alveolar ridge, which supports teeth in the jaw, will be measured before extraction and four months after healing. A cone beam CT Scan will also be obtained.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Alveolar ridge resorption after tooth extraction poses a substantial obstacle for subsequent implant placement, frequently necessitating ridge augmentation treatments. Alveolar ridge preservation (ARP) is intended to reduce these dimensional alterations. Various grafting materials have been used for ARP, with varying success rates in maintaining ridge dimensions. This study compares the clinical and radiological outcomes of a composite graft plug of bioactive resorbable calcium apatite crystals embedded in a collagen matrix to a typical allograft.

This randomized controlled clinical experiment comprised 26 people needing a single-rooted tooth extracted. They were divided into two groups: composite plug and allograft. Clinical measures of soft tissue were collected at baseline and four months after extraction using a stent with reference points. At baseline and four months after extraction, radiographic examinations were performed using cone beam computed tomography (CBCT).

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

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

  • Saudi Arabia
    • Makkah
      • Jeddah, Makkah, Saudi Arabia, 21589
        • King Abdulaziz 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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years or older
  • planned for extraction and alveolar ridge preservation of a single-rooted tooth - -- healthy or have well-controlled systemic disease
  • good oral hygiene
  • healthy periodontium or at least at the extraction area.

Exclusion Criteria:

  • smoking ≥10 cigarettes per day
  • generalized periodontitis
  • poor oral hygiene
  • uncontrolled systemic diseases such as diabetes
  • pregnancy
  • history of anti-resorptive therapy such as bisphosphonate

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Composite graft plug
composite graft plug was placed in the socket after extraction
Biological: Composite graft plug
after tooth extraction the socket was grafted with a composite graft plug
Active Comparator: Allograft
allograft was placed in the socket after extraction
Biological: Allograft
after tooth extraction the socket was grafted with allograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical and radiographic ridge alterations
Time Frame: four months

Using a standardized stent with reference points , the following horizontal clinical measurements were obtained before extraction through the stent holes: buccal soft tissue thickness at 4, 7, and 10 mm apical to the gingival margin and palatal or lingual soft tissue thickness at similar sites. Vertical measurements were obtained an incisal or occlusal hole to the buccal aspect of the ridge (inciso-buccal) and the palatal/ lingual aspect (inciso-palatal). Radiographic width of the alveolar ridge was measure at the same reference points.

theses measurements were taken at baseline (before extraction) and at 4 months after extraction and socket graft
four months

Collaborators and Investigators

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

Sponsor

King Abdulaziz University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2021

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

September 25, 2024

First Submitted That Met QC Criteria

September 25, 2024

First Posted (Actual)

September 27, 2024

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 27, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • REC 4350-444

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Age, Medical condition, gender

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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