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IRCT20260502069226N1 IRCT 2026-06-22 Oroumia University of Medical Sciences The Effect of Flowable Composite Application Following Palatal Soft Tissue Harvesting Evaluation of the Effect of Flowable Resin Composite on Pain and Wound Healing After Bilateral Standardized Palatal Soft Tissue Harvesting: A Randomized Clinical Trial 2026-05-21 anticipated 10 Complete https://irct.ir/trial/89770 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: Following the confirmation of inclusion and exclusion criteria, informed consent will be obtained from the patients. Then, the right or left side of each patient will be randomly assigned to receive either the intervention or the standard dressing. Patients will be informed of the difference in the dressings on the two sides, but they will remain blinded to which side is assigned to the intervention or the control group. To maintain the blinding of the assessor, pain intensity on the VAS will be recorded by an individual who solely evaluates the pain of each side separately without being aware of the intervention type. Furthermore, before the clinical assessment and EHI scoring, the dressings on both sides will be removed by a separate individual to ensure the assessor remains blinded to the treatment allocation. N/A Free Gingival Graft. Intervention 1: Intervention Group: Free gingival graft (FGG) is one of the effective soft tissue grafting methods for increasing the width and thickness of keratinized gingiva and correcting mucogingival defects. In this study, one palatal side will be randomly selected as the intervention side for the harvest of keratinized gingiva. After tissue harvesting, the site will be covered with a gelatinous collagen sponge (Hemospon® ,Maquira Dental Group). This will then be secured with interrupted 5-0 monofilament sutures (SUPALON, supa medical devices). Additionally, a thin layer of light-curable flowable composite resin (DenFil Flow,Vericom Co.) applied using an applicator tip, will be placed over the sponge. This application aims to ensure complete coverage of the wound area without creating excess thickness that could cause discomfort. To mechanically stabilize the flowable composite resin on the dressing, sutures passed around or through the collagen sponge will be arranged in a cross-linked network or matrix. The composite resin will be placed within and upon this suture network, ensuring the material is firmly fixed in the wound site. The composite will then be polymerized using a dental light-curing unit for the duration recommended by the manufacturer (typically 20-40 seconds). Post-operative Care: Patients will receive one Novafen capsule (a combination drug containing 325 mg acetaminophen, 200 mg ibuprofen, and 40 mg caffeine) every 6 hours as a pain reliever. This will be administered uniformly to all patients to eliminate any confounding factors. Intervention 2: Control group: The contralateral side of the palate will be designated as the control. The wound will be covered with a gelatinous collagen sponge (Hemospon® ,Maquira Dental Group) and then secured with interrupted, non-absorbable 5-0 monofilament sutures (SUPALON, supa medical devices), ensuring complete adaptation without tension. Unlike the intervention side, this will not be covered with a flowable composite. Post-operative Care: Patients will receive one Novafen Iran Daru capsule (a combination drug containing 325 mg acetaminophen, 200 mg ibuprofen, and 40 mg caffeine) every 6 hours as a pain reliever. This will be administered uniformly to all patients to eliminate any confounding factors.". 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 Sajad Farrokhi
School of Dentistry, Mohtasham Street, Molavi 2, Behdari District, Urmia
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3365 0728 s.farrokhi007@gmail.com Oroumia University of Medical Sciences scientific Sajad Farrokhi
School of Dentistry, Mohtasham Street, Molavi 2, Behdari District, Urmia
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3365 0728 S.farrokhi007@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Clinical Indication for Bilateral Free Gingival Graft in the Mandibular Premolar/Molar Region Age between 18 and 65 years Desired General Health Ability to Comply With Postoperative Instructions and Attend Follow‑Up Appointments 18 years 65 years Both Smoking or other behaviors known to impair wound healing Pre-existing allergy to the materials used in the study K05 Gingivitis and periodontal diseases Treatment - Surgery Treatment - Surgery Intervention Group: Free gingival graft (FGG) is one of the effective soft tissue grafting methods for increasing the width and thickness of keratinized gingiva and correcting mucogingival defects. In this study, one palatal side will be randomly selected as the intervention side for the harvest of keratinized gingiva. After tissue harvesting, the site will be covered with a gelatinous collagen sponge (Hemospon® ,Maquira Dental Group). This will then be secured with interrupted 5-0 monofilament sutures (SUPALON, supa medical devices). Additionally, a thin layer of light-curable flowable composite resin (DenFil Flow,Vericom Co.) applied using an applicator tip, will be placed over the sponge. This application aims to ensure complete coverage of the wound area without creating excess thickness that could cause discomfort. To mechanically stabilize the flowable composite resin on the dressing, sutures passed around or through the collagen sponge will be arranged in a cross-linked network or matrix. The composite resin will be placed within and upon this suture network, ensuring the material is firmly fixed in the wound site. The composite will then be polymerized using a dental light-curing unit for the duration recommended by the manufacturer (typically 20-40 seconds). Post-operative Care: Patients will receive one Novafen capsule (a combination drug containing 325 mg acetaminophen, 200 mg ibuprofen, and 40 mg caffeine) every 6 hours as a pain reliever. This will be administered uniformly to all patients to eliminate any confounding factors. Control group: The contralateral side of the palate will be designated as the control. The wound will be covered with a gelatinous collagen sponge (Hemospon® ,Maquira Dental Group) and then secured with interrupted, non-absorbable 5-0 monofilament sutures (SUPALON, supa medical devices), ensuring complete adaptation without tension. Unlike the intervention side, this will not be covered with a flowable composite. Post-operative Care: Patients will receive one Novafen Iran Daru capsule (a combination drug containing 325 mg acetaminophen, 200 mg ibuprofen, and 40 mg caffeine) every 6 hours as a pain reliever. This will be administered uniformly to all patients to eliminate any confounding factors." Degree of wound healing. Timepoint: Clinical assessment of the wound 14 days after the intervention. Method of measurement: Modified Early Wound Healing Index score. Postoperative pain intensity. Timepoint: On days 1, 3, 7, and 14 post-intervention. Method of measurement: Visual Analogue Scale. Oroumia University of Medical Sciences Approved 2026-01-28 Research Ethics Committees of Urmia University of Medical Sciences Urmia University of Medical Sciences, Orzhans Alley, Resalat St. ,Urmia urmia West Azarbaijan Iran (Islamic Republic of)