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IRCT20100427003813N12 IRCT 2022-04-14 Babol University of Medical Sciences Evaluating the effects of hyaluronic acid mucoadhesive films with two different concentrations on palatal epithelial wound healing and post-operative discomforts after free gingival graft surgery Evaluating the effects of hyaluronic acid mucoadhesive films with two different concentrations on palatal epithelial wound healing and post-operative discomforts after free gingival graft surgery 2022-04-08 anticipated 39 Complete https://irct.ir/trial/62161 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In order to randomly grouping the participants, we will use the option of generating random numbers in https://kitset.ir. Then, according to the random numbers, the first 13 numbers are in the first group, the next 13 numbers are in the second group, and the last 13 numbers are in the third group. Finally, the labeled biofilms (by the pharmacologist) are used in individuals of the all three groups, Blinding description: The biofilms containing hyaluronic acid with two different concentrations and the biofilms without hyaluronic acid are labeled with numbers by the pharmacologist and provided for the operator. The operator will be unaware of the type of biofilm used in the patient. N/A palatal epithelial wound healing and post-operative discomforts after free gingival graft surgery. Intervention 1: Intervention group 1: mucoadhesive films containing hyaluronic acid 0.8%. Intervention 2: Intervention group 2 : mucoadhesive films containing hyaluronic acid 0.2%. Intervention 3: Control group: mucoadhesive films without hyaluronic acid. 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 no more information
public Niloofar Jenabian
Ganjafrooz Ave.
Babol Iran (Islamic Republic of) 4717649811 +98 11 1229 1408 n.jenabian@mubabol.ac.ir Babol University of Medical Sciences scientific Niloofar Jenabian
Ganjafrooz Ave.
Babol Iran (Islamic Republic of) 4717649811 +98 11 1229 1408 n.jenabian@mubabol.ac.ir Babol University of Medical Sciences Iran (Islamic Republic of) Patients who required free gingival graft; Presence of sufficient donor tissue dimensions in the palate (length: 10-15 mm, width: 5-8 mm, thickness: 1-1.5 mm). 18 years no limit Both Systemic diseases and conditions affecting wound healing (such as uncontrolled diabetes, autoimmune diseases, history of alcoholism); Presence of attachment loss (greater than 3 mm) in the palatal area of ​premolars and first maxillary molars; Use of corticosteroids; Use of antibiotics in the past month; Pregnancy or breastfeeding; Smoking. Treatment - Other Treatment - Other Treatment - Other Intervention group 1: mucoadhesive films containing hyaluronic acid 0.8% Intervention group 2 : mucoadhesive films containing hyaluronic acid 0.2% Control group: mucoadhesive films without hyaluronic acid Complete epithelialization of the donor site in palate. Timepoint: 3, 7, 14, 21 and 42 days after surgery. Method of measurement: Landry 's healing index. Color matching, contour and distortion of the donor site in palate. Timepoint: 3, 7, 14, 21 and 42 days after surgery. Method of measurement: Modified Manchester Scar Proforma index. Postoperative pain. Timepoint: 3, 7, 14 and 21 days after surgery. Method of measurement: Visual analogue scale (VAS). Patient response to thermal stimulus after surgery. Timepoint: 3, 7, 14 and 21 days after surgery. Method of measurement: Visual analogue scale (VAS). Babol University of Medical Sciences Approved 2022-02-02 Research Ethics Committee of Babol University of Medical Sciences Ganj Afrooz Ave. Babol Mazandaran Iran (Islamic Republic of)