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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-06-01

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Extraction Socket Healing Socket Preservation Alveolar Ridge Preservation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Composite graft plug

composite graft plug was placed in the socket after extraction

Group Type EXPERIMENTAL

Composite graft plug

Intervention Type BIOLOGICAL

after tooth extraction the socket was grafted with a composite graft plug

Allograft

allograft was placed in the socket after extraction

Group Type ACTIVE_COMPARATOR

Allograft

Intervention Type BIOLOGICAL

after tooth extraction the socket was grafted with allograft

Interventions

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Composite graft plug

after tooth extraction the socket was grafted with a composite graft plug

Intervention Type BIOLOGICAL

Allograft

after tooth extraction the socket was grafted with allograft

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No