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

Not Applicable

Completed

• Conditions: Extraction Socket Healing; Socket Preservation; Alveolar Ridge Preservation
• Interventions: Biological: Composite graft plug; Biological: Allograft

• Registration Number: NCT06617221
• Lead Sponsor: King Abdulaziz University

Brief Summary

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.

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 Timeline

• Study Start: 2021-01-01
• Primary Completion: 2023-03-01
• Study Completion: 2023-06-01
• Status Verified: 2024-09
• Study First Submitted: 2024-09-25
• Study First Submitted QC: 2024-09-25
• Study First Posted: 2024-09-27
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Composite graft plug	Composite graft plug	composite graft plug was placed in the socket after extraction
Allograft	Allograft	allograft was placed in the socket after extraction

Primary Outcome Measures

Name	Time	Method
clinical and radiographic ridge alterations	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

Trial Locations

Locations (1)

King Abdulaziz University; 🇸🇦 Jeddah, Makkah, Saudi Arabia