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

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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Key information

Conditions

Extraction Socket Healing Alveolar Ridge Preservation Socket Preservation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Abdulaziz University

Jeddah, Mecca Region, 21589, Saudi Arabia

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Composite graft plug

Biological

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

Allograft

Biological

after tooth extraction the socket was grafted with allograft

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

Sponsors and collaborators

Lead sponsor

King Abdulaziz University

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Sep 27, 2024
Registry last updated: Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed