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IRCT20260505069264N1 IRCT 2026-05-17 Tehran University of Medical Sciences Evaluation of the effect of Tissue Adhesive on Palatal Wound healing Efficacy of Cyanoacrylate Tissue Adhesive (GLUBRAN® Tiss 2) Versus CoePak Periodontal Dressing on Palatal Wound After Following Free Gingival Graft Harvesting: A Randomized Double-Blind Clinical Trial 2026-07-23 anticipated 28 Recruiting https://irct.ir/trial/89868 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, participants are allocated to the two groups randomly and in a 1:1 equal ratio. For this purpose, random blocks of size four are generated using Excel software, such that within each block, two participants are assigned to the intervention group and two to the control group. The determination of which individual is assigned to which group is carried out randomly by a statistician who has no role in the conduct of the study, Blinding description: The allocation list will be kept in sealed envelopes until the start of surgery. Additionally, during the study, the blinding process will be maintained for patients and the data analyst to prevent bias. 3 Assessment of wound healing, pain intensity, and patient quality of life after palatal graft harvesting. Intervention 1: Intervention group: Patients in this group received GLUBRAN® 2 tissue adhesive on the palatal area after surgery. Intervention 2: Control group: Participants in this group received only 4‑0 silk sutures and Coe‑Pak periodontal dressing on the palatal area after surgery. The sutures were removed after two weeks. 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 -
public Farhan Gholamian baee
North karegar blv. dental faculity of tehran university
Tehran Iran (Islamic Republic of) 1439955934 +98 21 8801 5950 f_gholamianb@razi.tums.ac.ir Tehran University of Medical Sciences scientific Hoori Asl Roosta
End of North Kargar Street, before Shahid Hakim Highway, School of Dentistry, Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) 1439955934 +98 21 4279 4000 roosta.hoori@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients between 18 and 60 years of age Systemically healthy (ASA I) Without consumption of cigarettes, electronic cigarettes, waterpipe, or other forms of tobacco Having a clinical need for free gingival graft surgery around a tooth or dental implant 18 years 60 years Both Severe gag reflex Active periodontal diseases Tooth mobility Occlusal traumas Absence from follow-up sessions Systemic diseases that impair proper tissue healing or contraindicate periodontal surgery (e.g., diabetes, high-dose steroid use, pregnancy, radiotherapy, chemotherapy, coagulation disorders, or use of drugs that interfere with wound healing) Treatment - Other Treatment - Other Intervention group: Patients in this group received GLUBRAN® 2 tissue adhesive on the palatal area after surgery. Control group: Participants in this group received only 4‑0 silk sutures and Coe‑Pak periodontal dressing on the palatal area after surgery. The sutures were removed after two weeks. Assessment of patient pain intensity. Timepoint: Up to two weeks after surgery. Method of measurement: Pain intensity is measured using the VAS (Visual Analog Scale). Presence of bleeding. Timepoint: Up to one weeks after surgery. Method of measurement: through a questionnaire. Quality of life. Timepoint: One, two, three, and four weeks after surgery. Method of measurement: via the OHIP-14 questionnaire. Epithelialization of the wound area. Timepoint: One, two, three, and four weeks after surgery. Method of measurement: Via application of hydrogen peroxide (H₂O₂) to the wound and evaluation of the extent of bubbling. Color match of the area. Timepoint: One, two, three, and four weeks after surgery. Method of measurement: Analyzed using Adobe Photoshop CC 2017 software, the color difference between the healed area and the surrounding healthy tissue will be measured using standard colorimetric parameters, including brightness. Residual wound area. Timepoint: One, two, three, and four weeks after surgery. Method of measurement: Standardized images will be taken of the wound site in the palatal area using a Canon EOS 800D camera. The wound surface area will be calculated and recorded in square millimeters using ImageJ software (NIH, Bethesda, USA). Tehran University of Medical Sciences Approved 2026-04-20 The Ethics Committee of Tehran University of Medical Sciences Tehran, end of North Kargar Street, before Shahid Hakim Highway, School of Dentistry, Tehran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)