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Clinical Trials/NCT06617221
NCT06617221
Completed
Not Applicable

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

King Abdulaziz University1 site in 1 country24 target enrollmentJanuary 1, 2021

Overview

Phase
Not Applicable
Intervention
Composite graft plug
Conditions
Extraction Socket Healing
Sponsor
King Abdulaziz University
Enrollment
24
Locations
1
Primary Endpoint
clinical and radiographic ridge alterations
Status
Completed
Last Updated
last year

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
June 1, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Arwa Abubakr Badahdah

Assistant professor

King Abdulaziz University

Eligibility Criteria

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

Arms & Interventions

Composite graft plug

composite graft plug was placed in the socket after extraction

Intervention: Composite graft plug

Allograft

allograft was placed in the socket after extraction

Intervention: Allograft

Outcomes

Primary Outcomes

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

Study Sites (1)

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