]>
IRCT20250513065721N2 IRCT 2025-06-21 Mashhad University of Medical Sciences The effect of composite dressing on pain and bleeding control at the gingival graft donor site Evaluation of the effectiveness of a composite dressing in pain and bleeding control of the palatal graft donor site and comparison with collagen sponge 2025-06-22 anticipated 40 Complete https://irct.ir/trial/84287 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization will be used to ensure equal allocation of participants into the two study groups. Since the study includes two groups, the possible block permutations will be AB and BA. One of these blocks will be randomly selected, and participants will be assigned sequentially based on the selected block. For instance, if block AB is selected, the first participant will be allocated to Group A, the second to Group B, and the process will continue accordingly until all participants are assigned. This method ensures that both groups will have an equal number of participants. To maintain allocation concealment, the surgical information for each participant will be prepared in advance and placed in sealed, opaque, sequentially numbered envelopes. These envelopes will be handed to the surgeon by the surgical nurse immediately prior to each procedure, Blinding description: The surgeon and patients cannot be blinded due to the nature of the surgery and the physical differences in the procedures. Data analysts are unaware of the group allocation to avoid any bias. The induviduals responsible for recordinf patient-reported outcomes related to pain and bleeding during follow-up visits are also blinded. N/A palatal donor site for gingival graft. Intervention 1: Intervention group: Patients with mucogingival defects requiring gingival graft surgery will receive a composite dressing in combination with a resorbable collagen sponge to control bleeding and pain at the palatal donor site. After harvesting the autogenous gingival graft from the palate, a hemostatic collagen sponge will be placed over the wound, followed by placement of a pre-fabricated composite dressing. This dressing will be stabilized using a cross-mattress suture. The composite shield will be chairside-fabricated before surgery. First, the graft harvesting area is outlined. A rectangular frame is formed around this area using flowable composite and light-cured. The interior of the frame is then filled with additional flowable composite and cured. The fabricated composite dressing is gently removed from the palate and stored for placement at the end of surgery. Intervention 2: Control group: Patients with mucogingival defects requiring gingival graft surgery will receive only a resorbable collagen sponge to manage bleeding and pain at the palatal donor site. In this group, the wound will be covered with a resorbable collagen sponge with local hemostatic properties and stabilized using a cross-mattress suture. Yes - There is a plan to make this available What will be shared: Data related to age, gender, baseline and follow-up photographs of the donor site, palatal soft tissue thickness, dimensions (length, width, thickness) of the harvested graft, exact graft harvesting location on the palate, the amount of ibuprofen consumed by patients, and patient-reported Visual Analog Scale (VAS) scores at specified time points can be shared while maintaining confidentiality and excluding any personally identifiable information. When: The data access period will begin 6 months after the publication of the study results. To whom: Academic researchers Conditions: If other researchers require access to the data, methodology, or analyses used in this study for the purpose of writing articles or theses, the data can be shared while maintaining confidentiality and excluding any patient-identifying information. Where to obtain: The data can be shared upon request via email at z.moslehi99@gmail.com How to obtain: The data will be provided within a short period after the request is received. Comments:
public Moein Khojaste
Vakilabad Boulevard, Ferdowsi University West Gate, Faculty of Dentistry
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 Moein.Khojaste@yahoo.com Mashhad University of Medical Sciences scientific Farid Shiezade
Vakilabad Boulevard, Ferdowsi University West Gate, Faculty of Dentistry
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 shiezadehfr@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients with mucogingival defects (including lack of keratinized gingival width, gingival recession, insufficient vestibular depth) around teeth and implants, who require gum grafting surgery. The minimum thickness of the patient's palatal soft tissue should be 2 mm. The minimum height of patient's palatal vault should be 12 mm. 18 years no limit Both The presence of debilitating systemic disease, coagulation disorders, or any disease that has a significant impact on periodontal tissues (such as diabetes) Patients with known allergy to any of the materials used in the study Patients with gagging reflex patients with ongoing orthodontic treatment with palatal appliance Patients who wear maxillary dentures or overdentures that cover the palatal area. Patients with history of previous palatal soft tissue harvesting Presence of oral lesions in the palate Inability to maintain oral hygiene with at least 80% of plaque-free surfaces. Smoking and alcohol consumption. Z52.89 Donor of other specified organs or tissues Treatment - Surgery Treatment - Surgery Intervention group: Patients with mucogingival defects requiring gingival graft surgery will receive a composite dressing in combination with a resorbable collagen sponge to control bleeding and pain at the palatal donor site. After harvesting the autogenous gingival graft from the palate, a hemostatic collagen sponge will be placed over the wound, followed by placement of a pre-fabricated composite dressing. This dressing will be stabilized using a cross-mattress suture. The composite shield will be chairside-fabricated before surgery. First, the graft harvesting area is outlined. A rectangular frame is formed around this area using flowable composite and light-cured. The interior of the frame is then filled with additional flowable composite and cured. The fabricated composite dressing is gently removed from the palate and stored for placement at the end of surgery. Control group: Patients with mucogingival defects requiring gingival graft surgery will receive only a resorbable collagen sponge to manage bleeding and pain at the palatal donor site. In this group, the wound will be covered with a resorbable collagen sponge with local hemostatic properties and stabilized using a cross-mattress suture. Postoperative pain. Timepoint: Daily during the first 7 days and on day 14 postoperatively. Method of measurement: Using the patient-reported Visual Analog Scale and the amount of ibuprofen consumed (in milligrams). Donor site working time. Timepoint: during surgical process. Method of measurement: with stopwatch. Presence and severity of post surgical delayed bleeding. Timepoint: Daily for the first 7 days post surgical. Method of measurement: Patient-reported Visual Analogue Scale. Postoperative complications ( including necrosis, infection, and hematoma) in the palatal donor site. Timepoint: on day 7 post surgical. Method of measurement: visual clinical evaluation. The patient's willingness to undergo the same surgery again if needed. Timepoint: on day 7 post surgical. Method of measurement: Patient-reported Visual Analogue Scale. Postoperative discomfort and Inability to chew. Timepoint: on day 7 post surgical. Method of measurement: Patient-reported Visual Analogue Scale. Gingival graft dimensions (length, width, thickness). Timepoint: after harvesting the graft from palatal site. Method of measurement: Using a periodontal probe (in millimeters). Palatal soft tissue thickness at the mesial, distal, and central parts of the designated graft site. Timepoint: during surgical process before harvesting the graft from palatal site. Method of measurement: Using a local anesthesia needle with a stopper and a gauge accurate to 0.1 mm. Mashhad University of Medical Sciences Approved 2025-06-07 Ethics committee of Mashhad University of Medical Sciences Vakilabad Boulevard, Ferdowsi University West Gate, Faculty of Dentistry Mashhad Razavi Khorasan Iran (Islamic Republic of)