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IRCT20231115060072N1 IRCT 2023-12-12 Tehran University of Medical Sciences The success rate of gum grafting with and without dressing Comparing the success rate of free gingival graft treatment with and without using periodontal dressing in increasing keratinized gingival width and vestibule depth: a randomized clinical trial 2024-04-08 anticipated 26 Complete https://irct.ir/trial/73795 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple and individual randomization; People who meet the entry criteria are assigned a number and enter the study. Then, each number representing the patient is placed in one of the 2 intervention and control groups by the random number table. Sealed envelope method will be used for allocation concealment. Determining the placement of the dressing is written in the envelope for each patient, then on the day of the surgery, and at the end of that, the envelope for the patient is opened, and based on that, the dressing is placed or not at the surgery site, Blinding description: The researcher and the statistical analyst are blinded to the type of surgical technique performed in each patient. The data in two groups A and B will be given to the analyzer without mentioning whether each group is a test or a control. There is no possibility of blinding the patients due to the observation of the dressing in the mouth. Also, until the end of the surgery and the placement of the dressing, the surgeon is unaware of which group the patient is in, so that the surgical procedure does not differ between the groups. 3 Gingival transplant surgery technique. Intervention 1: Intervention group:Free gingival graft surgery is performed in the edentulous area posterior of the mandible. The graft is harvested from the palate. Finally, it is fixed in the intended place with stitches. Then, in patients, periodontal dressing is used in the fixation place. Intervention 2: Control group: Free gingival graft surgery is performed in the edentulous area posterior of the mandible. After preparing the recipient bed, the graft is harvested from the palate. Finally, the grafted tissue is fixed in the intended place with sutures. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Amirmohammad Dolatabadi
No. 31, Safavyan Alley, Sattar Khan Street, Tehran
Tehran Iran (Islamic Republic of) 1444783911 +98 21 6656 0137 armd.dolatabadi@gmail.com Tehran University of Medical Sciences scientific Neda Moslemi
North Kargar St, Tehran University of Medical Sciences Faculty of Dentistry
Tehran Iran (Islamic Republic of) 1439955934 +98 21 4279 4500 neda_moslemi@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) People who have placed at least two implants at the posterior of mandible due to partial edentulousness (as the most posterior teeth). Patients who have insufficient vestibular depth at the implants placement site. 18 years no limit Both Systemic disease that interferes with wound healing. Alcohol and drug abuse Cigarette smoking Uncontrolled periodontal disease Pregnant and lactating mothers Patients with parafunctional habits Treatment - Surgery Treatment - Surgery Intervention group:Free gingival graft surgery is performed in the edentulous area posterior of the mandible. The graft is harvested from the palate. Finally, it is fixed in the intended place with stitches. Then, in patients, periodontal dressing is used in the fixation place. Control group: Free gingival graft surgery is performed in the edentulous area posterior of the mandible. After preparing the recipient bed, the graft is harvested from the palate. Finally, the grafted tissue is fixed in the intended place with sutures. Vestibular depth. Timepoint: At the beginning of the study, 1 month after surgery, 3 months after surgery. Method of measurement: Intraoral scanner. Keratinized gingiva. Timepoint: At the beginning of the study, 1 month after surgery, 3 months after surgery. Method of measurement: Periodontal probe. Tehran University of Medical Sciences Approved 2023-11-15 Ethics Committee of Tehran University of Medical Sciences No. 31, Safavyan Alley, Sattar Khan Street, Tehran Tehran Tehran Iran (Islamic Republic of)