Radiographically evaluate the effect of the combined application of atorvastatin and collagen foam on alveolar bone healing following tooth extraction, using cone-beam computed tomography (CBCT) images, and to compare the outcomes with those of collagen foam alone.
Design
A phase II randomized, double-blind, parallel-group, controlled clinical trial will be conducted on 17 patients requiring tooth extraction. Participants will be randomly allocated into intervention and control groups using the RAND function in Microsoft Excel.
Settings and conduct
This study will be conducted at the Department of Oral and Maxillofacial Surgery, Tehran Azad Dental University, and bone healing after tooth extraction will be evaluated by CBCT after 3 months.
Participants/Inclusion and exclusion criteria
Inclusion criteria :Adult patients 18 years of age or older
stable periodontal status and good oral hygiene.
Ability and willingness to comply with study requirements, including attendance at follow-up sessions up to 3 months after the intervention.
Signing a written informed consent form prior to study entry.
exclusion criteria : Presence of active local or systemic infection or 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 use or history of medications that interfere with bone repair
Chronic use of corticosteroids
Intervention groups
following tooth extraction and socket debridement, collagen foam impregnated with atorvastatin will be placed into the extraction socket.
Control group: following tooth extraction and socket debridement, only sterile absorbable collagen foam without atorvastatin will be placed in socket.
Main outcome variables
The outcome variable of this study is the radiographic bone healing of the extraction socket
General information
Reason for update
Acronym
ACB-Heal Trial
IRCT registration information
IRCT registration number:IRCT20260427069191N1
Registration date:2026-05-05, 1405/02/15
Registration timing:prospective
Last update:2026-05-05, 1405/02/15
Update count:0
Registration date
2026-05-05, 1405/02/15
Registrant information
Name
aida nazarzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 910 916 8830
Email address
aidanazarzade95@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-05-15, 1405/02/25
Expected recruitment end date
2026-08-16, 1405/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Radiographic study of simultaneous use of atorvastatin and collagen foam in dentate gingival recession on CBCT images.
Public title
Evaluation of the Combined Effect of Atorvastatin and Collagen Foam on Bone Healing After Tooth Extraction Using CBCT Images
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
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.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
17
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University, Tehran Medical Branch
Street address
Dr. Shariati St
City
Tehran
Province
Tehran
Postal code
1941933111
Approval date
2025-09-14, 1404/06/23
Ethics committee reference number
IR.IAU.DENTAL.REC.1404.066
Health conditions studied
1
Description of health condition studied
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.
ICD-10 code
K05.31
ICD-10 code description
Chronic periodontitis, localized
Primary outcomes
1
Description
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.
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farhikhtegan hospital
Full name of responsible person
Farhad Noravesh
Street address
Poonak Ave
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 910 916 8830
Email
aidanazarzade95@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Mehrdad Gholamzad
Street address
Dr. Shariati St
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2200 6660
Email
research@tms.iau.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farhad Noravesh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
Poonak
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 910 916 8830
Email
aidanazarzade95@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sanaz Heidarkhan Tehrani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
Islamic Azad University, Tehran Dental Branch, Pasdaran St., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 2200 6660
Fax
Email
sanaztehrani@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farhad Noravesh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
Poonak
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 2200 6660
Fax
Email
aidanazarzade95@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
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 the data will become available and for how long
Access begins 3 months after results are published.
To whom data/document is available
Researchers working at academic institutions
Under which criteria data/document could be used
The data/document may be used exclusively for academic and scientific research purposes
From where data/document is obtainable
The data and source documents are obtainable from the , Islamic Azad University, Tehran Medical Sciences dental Branch.
What processes are involved for a request to access data/document
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.