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IRCT20100427003813N13 IRCT 2023-03-06 Babol University of Medical Sciences Comparison of the effects of two incision designs; Double flap and Periosteal releasing, on soft tissue changes following guided bone regeneration (GBR) Comparison of the effects of two incision designs; Double flap and Periosteal releasing, on soft tissue changes following guided bone regeneration, in patients with horizontal ridge defect on posterior mandible 2023-01-21 anticipated 24 Complete https://irct.ir/trial/67690 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: To randomize the samples, the option of generating random numbers on the kitset.ir site was used. For this purpose, random numbers from 1 to 24 was generated as follows, the first half of which case number will be operated by Double flap incision (DFI) method and the second half by Periosteal releasing incision (PRI) method. In the checklist of each patient, only one number is written and the surgical technique used is not specified, so neither the patient nor the examiner knows about the surgical technique used, Blinding description: In this study, the participant (patient) and the examiner who performs the examination in the follow-up appointments and records the results in the data sheet, do not know which group the patient is in and which surgical technique was used for the patient, because the type of technique will not be recorded in the patient's data sheet, and patients will only be identified by a number and from the appearance of the surgical site, the type of technique cannot be recognized. so the study is double-blinded. The only person who knows the surgical technique is the surgeon, who is not involved in recording the results. N/A Severe horizontal alveolar bone deformity(Seibert Class I). Intervention 1: Intervention group: The surgical method adopted in this group to reduce tension for flap advancement includes partial thickness flap elevation, which leaves the periosteal layer on the edentulous ridge and separates the mucosal layer of the flap. The periosteal layer of the flap stabilizes the reconstruction site using periosteal sutures. A crestal incision will be made with a vertical releasing incision 2 mm from the most distal tooth with a #15 blade. The crestal incision will be extended distal to the flap to avoid traction. Then a partial thickness flap that separates the mucosal flap from the periosteum that covers the alveolar bone, will be made on the buccal side. After sufficient separation between the external (mucosal) and internal (periosteal) flaps, the periosteal flap will be raised from the bone surface. Then a full thickness lingual mucoperiosteal flap is raised. After that, a 1˟2 cm collagen membrane from Kish Tissue Replicator will be used to create a space free of soft tissue. The bone defect will be filled with half a cc of freeze-dried mineralized bone allograft from Kish Tissue Replicator. The periosteal flap will be placed and fixed with 4-0 Vicryl sutures using two horizontal sutures. Intervention 2: Control group: In this group, the gold standard method, periosteal releasing incision, will be used for surgery. In the missing tooth site with horizontal bone defect, an incision will be made using a 15 blade to divide the gingival flap into 2 equal parts. The flap is elevated full thickness on both buccal and lingual sides. Then, to free the flap from tension, a periosteal incision is made with a 15 blade on both buccal and lingual sides. Then, as in Group 1, a collagen membrane will be used to create a soft tissue-free space. The bone defect will be filled with freeze-dried mineralized bone graft. The flap will be fixed with 4-0 vicryl figure C sutures. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts 6 months after the results are published To whom: The data will be available to researchers working in academic and scientific institutions or people working in industry Conditions: It is possible to use data or documents for further studies or to choose a more appropriate treatment method for patients Where to obtain: To receive documents or data, contact Dr. Niloofar Jenabian at the following email address. njenabian@hotmail.com How to obtain: Wait for a reply by sending a request email to the above address Comments:
public Niloofar Jenabian
University of medical sciences, Ganj afrooz Street, Babol
Babol Iran (Islamic Republic of) 4717647745 +98 11 1229 1408 n.jenabian@mubabol.ac.ir Babol University of Medical Sciences scientific Niloofar Jenabian
University of medical sciences, Ganj afrooz Street, Babol
Babol Iran (Islamic Republic of) 4717647745 +98 11 1229 1408 n.jenabian@mubabol.ac.ir Babol University of Medical Sciences Iran (Islamic Republic of) Has severe horizontal alveolar bone deformity(Seibert Class I) and requires guided bone regeneration treatment in the posterior region of the mandible 21 years no limit Both History of smoking History of systemic disease History of unexplained allergies Treatment - Surgery Treatment - Surgery Intervention group: The surgical method adopted in this group to reduce tension for flap advancement includes partial thickness flap elevation, which leaves the periosteal layer on the edentulous ridge and separates the mucosal layer of the flap. The periosteal layer of the flap stabilizes the reconstruction site using periosteal sutures. A crestal incision will be made with a vertical releasing incision 2 mm from the most distal tooth with a #15 blade. The crestal incision will be extended distal to the flap to avoid traction. Then a partial thickness flap that separates the mucosal flap from the periosteum that covers the alveolar bone, will be made on the buccal side. After sufficient separation between the external (mucosal) and internal (periosteal) flaps, the periosteal flap will be raised from the bone surface. Then a full thickness lingual mucoperiosteal flap is raised. After that, a 1˟2 cm collagen membrane from Kish Tissue Replicator will be used to create a space free of soft tissue. The bone defect will be filled with half a cc of freeze-dried mineralized bone allograft from Kish Tissue Replicator. The periosteal flap will be placed and fixed with 4-0 Vicryl sutures using two horizontal sutures. Control group: In this group, the gold standard method, periosteal releasing incision, will be used for surgery. In the missing tooth site with horizontal bone defect, an incision will be made using a 15 blade to divide the gingival flap into 2 equal parts. The flap is elevated full thickness on both buccal and lingual sides. Then, to free the flap from tension, a periosteal incision is made with a 15 blade on both buccal and lingual sides. Then, as in Group 1, a collagen membrane will be used to create a soft tissue-free space. The bone defect will be filled with freeze-dried mineralized bone graft. The flap will be fixed with 4-0 vicryl figure C sutures. The amount of flap advancement during surgery. Timepoint: During surgery, before tension freeing the flap with one of techniques and after that. Method of measurement: Measuring the amount of the flap advancement compared to its base during surgery with UNC-15 probe. Membrane exposure. Timepoint: 3rd day and 1, 2, 4, 12 and 24 weeks after surgery. Method of measurement: Did membrane exposed in the mouth in follow-up stages or not?. Infection. Timepoint: 3rd day and 1, 2, 4, 12 and 24 weeks after surgery. Method of measurement: Is there pus at the surgical site in the follow-up stages or not?. Paraesthesia. Timepoint: 3rd day and 1, 2, 4, 12 and 24 weeks after surgery. Method of measurement: Is there sensory disorders related to surgery in the follow-up stages or not?. Continuous discomfort. Timepoint: 3rd day and 1, 2, 4, 12 and 24 weeks after surgery. Method of measurement: Is there any expression of discomfort in the surgical area by the patient in the follow-up stages or not?. Pain. Timepoint: 3rd day and 1, 2, 4, 12 and 24 weeks after surgery. Method of measurement: by Visual Analogue Scale. Swelling. Timepoint: 3rd day and 1, 2, 4, 12 and 24 weeks after surgery. Method of measurement: by Visual Analogue Scale. Bleeding. Timepoint: 3rd day and 1, 2, 4, 12 and 24 weeks after surgery. Method of measurement: by Visual Analogue Scale. Healing of surgery site. Timepoint: 3rd day and 1, 2, 4, 12 and 24 weeks after surgery. Method of measurement: by Wound healing index. Babol University of Medical Sciences Approved 2022-11-28 Ethics committee of Babol University of Medical Sciences University of medical sciences, Ganj afrooz street, Babol Babol Mazandaran Iran (Islamic Republic of)