Clinical trial NCT06617221: Alveolar Ridge Preservation Using a Composite Graft Plug: Radiographic and Clinical Assessment
Official title: Alveolar Ridge Preservation Using a Composite Graft Plug: Radiographic and Clinical Assessment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Extraction Socket Healing
Socket Preservation
Alveolar Ridge Preservation
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: clinical and radiographic ridge alterations
timeFrame: four months
Secondary outcomes:
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz University
state: Makkah
Study officials:
References:
citation: Jafarian J, Shahrabi-Farahani S, Ferreira CF, Stewart CW, Luepke P. Histological Evaluation of Alveolar Ridge Preservation Using Different Bone Grafts: Clinical Study Analysis Part II. J Oral Implantol. 2024 Jun 1;50(3):260-265. doi: 10.1563/aaid-joi-D-23-00060.
citation: Jones K, Williams C, Yuan T, Digeorge-Foushee AM, Chambers Wilson R, Burton T, Hamlin N, Martinez L. Comparative in vitro study of commercially available products for alveolar ridge preservation. J Periodontol. 2022 Mar;93(3):403-411. doi: 10.1002/JPER.21-0087. Epub 2021 Jul 12.