]>
IRCT20260308068974N1 IRCT 2026-07-24 Mashhad University of Medical Sciences Comparison of two barrier membranes for extraction socket tissue regeneration Comparative Evaluation of Soft Tissue Healing at Molar and Premolar Socket During Two-Stage Immediate Implant Placement Using Collagen Sponge versus Acellular Dermal Matrix (ADM): A Clinical Trial study 2026-06-05 anticipated 40 Recruiting https://irct.ir/trial/90189 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly allocated to the two study groups using a permuted block randomization method. The randomization sequence will be generated using Randomization.org. Given that there are two study groups, a block size of four will be used, with the possible allocation sequences being AABB, ABAB, ABBA, BAAB, BABA, and BBAA. An independent researcher who is not involved in patient treatment or outcome assessment will generate and maintain the randomization sequence. To ensure allocation concealment, the assigned group for each participant will be placed in sequentially numbered opaque sealed envelopes (SNOSE). After a participant has been enrolled in the study and immediately before surgery, the corresponding envelope will be provided to the surgeon by the operating room nurse and opened at that time. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes prepared by an independent researcher. The envelopes will be opened only after participant enrollment and immediately before surgery. The surgeon will receive the allocation information at the time of intervention, Blinding description: This study will be conducted using a single-blind design. Due to the nature of the surgical interventions, blinding of the surgeon will not be feasible. Participants will be informed about the treatment they receive as part of the consent process; therefore, patient blinding will not be implemented. However, radiographic evaluators, histomorphometric assessors, and data analysts will remain blinded to group allocation throughout outcome assessment and statistical analysis. Group coding will be performed by an independent researcher who is not involved in treatment delivery or outcome evaluation. Allocation information will be disclosed only after completion of the final statistical analysis. N/A socket closure. Intervention 1: "Intervention Group 1": After tooth extraction and socket preparation, immediate implant placement will be performed in the fresh socket during the same treatment session. The socket entrance will be covered using an absorbable collagen matrix (Collagen Matrix). This material is a xenogenic biomaterial derived from type I collagen and, after hydration, will be placed over the socket entrance and fixed with sutures. The collagen matrix used belongs to the Coltene company, Switzerland. The dimensions of the collagen matrix are 14*7*7 mm. This material is a sponge-like scaffold made of animal-derived gelatin with a porous structure. Intervention 2: "Intervention Group 2": After tooth extraction and socket preparation, immediate implant placement will be performed in the fresh socket during the same treatment session. The socket entrance will be covered using an Acellular Dermal Matrix (ADM). This material is prepared from human dermal tissue after complete removal of cellular components and acts as a biological scaffold for soft tissue regeneration. ADM will be placed over the socket entrance after hydration and will be fixed with sutures. This material is manufactured by Iranian Tissue Products Company. The thickness of the material used is 0.2 to 0.6 mm, and its dimensions are 10*15 mm. Its chemical composition is cadaveric human skin dermis from which the cells have been removed, and the remaining extracellular matrix is preserved. Yes - There is a plan to make this available What will be shared: Data related to age, gender, baseline and follow-up photographic images, initial non-epithelialized surface area, involved tooth locations and percentage of epithelialized surface at the recorded time points will be available for sharing. All data will be anonymized and stripped of any personal identifiers to ensure patient confidentiality. When: The data access period will begin 6 months after the publication of the study results. To whom: Academic researchers Conditions: If other researchers require access to the data, methodology, or analyses used in this study for the purpose of writing articles or theses, the data can be shared while maintaining confidentiality and excluding any patient-identifying information. Where to obtain: The data can be shared upon request via email at msaeid19971376@gmail.com How to obtain: The data will be provided within a short period after the request is received. Comments:
public Dr. Farid Shiezadeh
Faculty of Dentistry, Ferdowsi University of Mashhad, West Gate, Vakilabad Boulevard
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 shiezadehfr@mums.ac.ir Mashhad University of Medical Sciences scientific Dr. Moein Khojaste
Faculty of Dentistry, Ferdowsi University of Mashhad, West Gate, Vakilabad Boulevard
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 Moein.Khojaste@yahoo.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Good general health Good oral hygiene Need for molar tooth extraction with an indication for immediate implant placement in a fresh socket Presence of at least 5 mm of available bone to achieve primary implant stability 18 years no limit Both Smoking Systemic and Metabolic Diseases History of Chemotherapy or Radiotherapy Pregnancy Recent Use of Antibiotics or Corticosteroids Use of Medications Affecting Bone Metabolism K08.1 Complete loss of teeth Treatment - Surgery Treatment - Surgery "Intervention Group 1": After tooth extraction and socket preparation, immediate implant placement will be performed in the fresh socket during the same treatment session. The socket entrance will be covered using an absorbable collagen matrix (Collagen Matrix). This material is a xenogenic biomaterial derived from type I collagen and, after hydration, will be placed over the socket entrance and fixed with sutures. The collagen matrix used belongs to the Coltene company, Switzerland. The dimensions of the collagen matrix are 14*7*7 mm. This material is a sponge-like scaffold made of animal-derived gelatin with a porous structure. "Intervention Group 2": After tooth extraction and socket preparation, immediate implant placement will be performed in the fresh socket during the same treatment session. The socket entrance will be covered using an Acellular Dermal Matrix (ADM). This material is prepared from human dermal tissue after complete removal of cellular components and acts as a biological scaffold for soft tissue regeneration. ADM will be placed over the socket entrance after hydration and will be fixed with sutures. This material is manufactured by Iranian Tissue Products Company. The thickness of the material used is 0.2 to 0.6 mm, and its dimensions are 10*15 mm. Its chemical composition is cadaveric human skin dermis from which the cells have been removed, and the remaining extracellular matrix is preserved. Percentage of epithelial coverage of socket orifice. Timepoint: Day 0 (immediately after the intervention), 1 week after the intervention, 2 weeks after the intervention, and 4 weeks after the intervention. Method of measurement: In this study, ImageJ software will be used to assess percentage changes in epithelialized surface area at different follow-up intervals. After importing the images into the software, the Freehand Selection tool will be used to delineate the stained areas, which will be considered non-epithelialized regions. In contrast, the unstained areas after methylene blue application will be regarded as epithelialized regions. The epithelialized and non-epithelialized areas will then be quantified as a percentage of the total surface area in each image. Mashhad University of Medical Sciences Approved 2026-05-02 Ethics committee of Mashhad Faculty of Dentistry Faculty of Dentistry, Ferdowsi University of Mashhad, West Gate, Vakilabad Boulevard Mashhad Razavi Khorasan Iran (Islamic Republic of)