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IRCT20260427069191N1 IRCT 2026-05-05 Islamic Azad University Evaluation of the Combined Effect of Atorvastatin and Collagen Foam on Bone Healing After Tooth Extraction Using CBCT Images ACB-Heal Trial Radiographic study of simultaneous use of atorvastatin and collagen foam in dentate gingival recession on CBCT images. 2026-05-15 anticipated 17 Complete https://irct.ir/trial/89691 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly allocated to the study groups using a computer-generated randomization sequence. In cases where a split-mouth design is used, the allocation of each extraction socket to either the intervention or control group will be determined by computer-generated randomization. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes (SNOSE) prepared by an independent researcher not involved in treatment or outcome assessment, Blinding description: This study will be conducted as a double-blind randomized clinical trial. The participants and the radiographic evaluator/statistical analyst will be blinded to the treatment allocation. The surgeon performing the intervention will not be blinded due to the nature of the procedure. The materials used in both groups will be prepared in identical containers and coded by an independent researcher who is not involved in treatment or outcome assessment. The allocation code will remain concealed until completion of data analysis. N/A The health condition studied is alveolar bone defect/healing after tooth extraction. Tooth extraction leads to physiological bone resorption and delayed bone regeneration in the extraction socket, which may affect future prosthetic or implant treatment outcomes.. Participants allocated to the intervention group will receive local alveolar ridge preservation treatment immediately after tooth extraction using a sterile absorbable collagen foam scaffold impregnated with atorvastatin. The collagen foam will serve as a biocompatible carrier for the localized delivery of atorvastatin into the extraction socket. Following atraumatic tooth extraction and socket debridement, the atorvastatin-loaded collagen foam will be placed into the socket to fill the defect adequately. The site may then be sutured if necessary to stabilize the material and promote healing.Atorvastatin is used due to its potential osteogenic, angiogenic, and anti-inflammatory effects, which may enhance bone regeneration and reduce post-extraction alveolar bone resorption. The collagen foam is selected as a biodegradable scaffold to support clot stabilization and gradual release of the active agent during the healing period.Participants will be followed clinically and radiographically during the postoperative healing period, with assessments performed at predefined follow-up 3 months after intervention) to evaluate bone preservation and regeneration outcomes.. Yes - There is a plan to make this available What will be shared: Individual data of participants after removal of identifying information (De-identified data), including data related to the main outcome of the study (bone density and percentage of bone filling in CBCT images), will be shared upon reasonable request of the researchers and after the publication of the study results. When: Access begins 3 months after results are published. To whom: Researchers working at academic institutions Conditions: The data/document may be used exclusively for academic and scientific research purposes Where to obtain: The data and source documents are obtainable from the , Islamic Azad University, Tehran Medical Sciences dental Branch. How to obtain: Access to the data and documents of this study requires the submission of an official research request and obtaining approval from the Research and Technology Deputy of Islamic Azad University, Tehran Medical Sciences Branch, as well as the Research Ethics Committee. After the research proposal is approved and an ethics permit is issued, access to the data will only be possible for members of the research team and within the framework of the approved study objectives. All data will be provided to researchers in an anonymized form before use in research, and their use is limited to the approved scientific and research purposes. Any use outside the scope of the study requires obtaining additional permissions. Comments:
public Farhad Noravesh
Poonak
Tehran Iran (Islamic Republic of) 1477893855 +98 910 916 8830 aidanazarzade95@gmail.com Islamic Azad University scientific Sanaz Heidarkhan Tehrani
Islamic Azad University, Tehran Dental Branch, Pasdaran St., Tehran, Iran.
Tehran Iran (Islamic Republic of) 1477893855 +98 21 2200 6660 sanaztehrani@gmail.com Islamic Azad University Iran (Islamic Republic of) Adults aged 18 years or older requiring extraction of at least two teeth and subsequent bone regeneration procedures in the extraction sites. Patients with stable periodontal status and good oral hygiene Ability and willingness to comply with study requirements, including attendance at scheduled follow-up visits for up to 3 months. Provision of written informed consent prior to participation. 18 years no limit Both Presence of active local or systemic infection/inflammation. Presence of systemic or local diseases that may interfere with bone healing, including but not limited to uncontrolled diabetes mellitus (HbA1c >7%), osteoporosis, and hyperparathyroidism. Current or previous use of medications known to interfere with bone healing Chronic corticosteroid therapy. Known allergy or hypersensitivity to bone graft materials, collagen foam, or atorvastatin. K05.31 Chronic periodontitis, localized Treatment - Drugs Participants allocated to the intervention group will receive local alveolar ridge preservation treatment immediately after tooth extraction using a sterile absorbable collagen foam scaffold impregnated with atorvastatin. The collagen foam will serve as a biocompatible carrier for the localized delivery of atorvastatin into the extraction socket. Following atraumatic tooth extraction and socket debridement, the atorvastatin-loaded collagen foam will be placed into the socket to fill the defect adequately. The site may then be sutured if necessary to stabilize the material and promote healing.Atorvastatin is used due to its potential osteogenic, angiogenic, and anti-inflammatory effects, which may enhance bone regeneration and reduce post-extraction alveolar bone resorption. The collagen foam is selected as a biodegradable scaffold to support clot stabilization and gradual release of the active agent during the healing period.Participants will be followed clinically and radiographically during the postoperative healing period, with assessments performed at predefined follow-up 3 months after intervention) to evaluate bone preservation and regeneration outcomes. Radiographic bone healing of the extraction socket will be assessed using CBCT imaging by measuring bone density and bone fill percentage at 3 months after the intervention. Timepoint: Three months after the intervention. Method of measurement: The outcome will be measured using cone-beam computed tomography (CBCT) images to assess bone density and bone fill percentage in the extraction socket. Islamic Azad University Approved 2025-09-14 Ethics committee of Islamic Azad University, Tehran Medical Branch Dr. Shariati St Tehran Tehran Iran (Islamic Republic of)