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IRCT20231118060098N1 IRCT 2024-01-12 Tehran University of Medical Sciences The effect of pineapple gel on palatal wound healing after gingival graft Investigating The Effect Of Bromelain Gel Added To Periodontal Pack Compared To Periodontal Pack Alone On The Healing Of Palatal Wound Resulting From Harvesting The Free Gingival Graft On Patients With Keratinized Gingival Width Deficiency Who Are Candidates For Gingival Grafting; A Parallel Clinical Trial Study 2024-03-10 anticipated 28 Complete https://irct.ir/trial/73837 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The samples are randomly divided into two groups using balance block randomization (size = 4). For this purpose, the allocation method in each of the blocks is determined using Excel software in such a way that at least 2 samples of any intervention are in each block. The randomization process is carried out by the study methodology consultant. The type of allocation after randomization is noted in the envelope with numbers 1 to 28 for each sample. When conducting the study, the operator opens the envelopes in order and aware of the type of sample's allocation at the time of intervention, Blinding description: People entered in the study, knowing that they are participating in a research study, are blinded to the allocation to the desired treatment group, and the statistical analyzer is blinded to the type of surgical technique performed in each patient. Both groups receive periodontal packs with the same color, taste and shape, so the patient does not know the presence or absence of gel under the pack. 3 Palate wound. Intervention 1: Intervention group: In this study free gingival graft surgery is performed by removing the graft from the palate area, 1% bromelain gel, a polymer gel made from mixing biocompatible polymer and water (at high temperature) and a microbial protector that is allowed to be used in the mouth (to prevent microbial contamination), with the active ingredient of the study that It is bromelain powder. After surgery, 1% bromelain gel is placed on the wound area for patients in this group, and after applying the gel, a periodontal pack is placed on the palatal wound area. The gel is applied on the area on the day of surgery and two days later. Intervention 2: Control group: Free gingival graft surgery is performed by removing the graft from the palate area. After the surgery, no gel is placed on the wound area of the patients in this group, and only periodontal pack is placed on the area of the palate wound. 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 Fateme Godarzi Moghadam
Dental school; not reaching Hakim highway; At the end of North Kargar street
Tehran Iran (Islamic Republic of) 1439955991 +98 21 4279 4000 fateme.godarzii1998@gmail.com Tehran University of Medical Sciences scientific Fateme Godarzi Moghadam
Dental school; not reaching Hakim highway; At the end of North Kargar street
Tehran Iran (Islamic Republic of) 1439955991 +98 21 4279 4000 fateme.godarzii1998@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients over 18 years old The need for free gingival graft around the tooth or implant Systemically healthy Non-smokers Graft dimensions 10 mm wide and 15 to 20 mm long 18 years no limit Both Active gag reflex Presence of periodontal disease Lack of sensation Mobility and occlusal trauma Missing canine teeth up to maxillary first molar Additional forces including mechanical forces from orthodontics and traumatic occlusion Systemic diseases that are contraindications for periodontal surgeries or have interactions by tissue repair Pregnancy and breastfeeding Treatment - Drugs Treatment - Surgery Intervention group: In this study free gingival graft surgery is performed by removing the graft from the palate area, 1% bromelain gel, a polymer gel made from mixing biocompatible polymer and water (at high temperature) and a microbial protector that is allowed to be used in the mouth (to prevent microbial contamination), with the active ingredient of the study that It is bromelain powder. After surgery, 1% bromelain gel is placed on the wound area for patients in this group, and after applying the gel, a periodontal pack is placed on the palatal wound area. The gel is applied on the area on the day of surgery and two days later. Control group: Free gingival graft surgery is performed by removing the graft from the palate area. After the surgery, no gel is placed on the wound area of the patients in this group, and only periodontal pack is placed on the area of the palate wound. The average area of the remaining wound in the palate. Timepoint: Days 7, 14, 21 and 28 after surgery. Method of measurement: Image J computer program to check the area of the remaining wound. The amount of bleeding after surgery. Timepoint: The first 3 days after surgery. Method of measurement: Questionnaire and observation. The degree of color matching. Timepoint: Days 7, 14, 21 and 28 after surgery. Method of measurement: Adobe Photoshop CS3 computer program to check Brightness parameters. The amount of epithelialization. Timepoint: Days 7, 14, 21 and 28 after surgery. Method of measurement: Using 3% H2O2 and observing oxygen bubbles. Average index of pain and discomfort. Timepoint: Days 7, 14, 21 and 28 after surgery. Method of measurement: Questionnaire and VAS chart. Lundry's healing index next. Timepoint: Days 7, 14, 21 and 28 after surgery. Method of measurement: Direct touch and examination by a specialist. Tehran University of Medical Sciences Approved 2023-10-21 Ethics committee of Tehran University of Medical Sciences Dental school; not reaching Hakim highway; At the end of North Kargar street Tehran Tehran Iran (Islamic Republic of)