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

King Abdulaziz University

Status: Completed

Conditions: Extraction Socket Healing; Socket Preservation; Alveolar Ridge Preservation

Treatments: Biological: Composite graft plug; Biological: Allograft

Study type: Interventional

Funder types: Other

Identifiers

NCT06617221

REC 4350-444

Details and patient eligibility

About

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.

Full 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).

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Composite graft plug

Experimental group

Description:

composite graft plug was placed in the socket after extraction

Treatment:

Biological: Composite graft plug

Allograft

Active Comparator group

Description:

allograft was placed in the socket after extraction

Treatment:

Biological: Allograft