Evaluation of the effectiveness of a composite dressing in pain and bleeding control of the palatal graft donor site and comparison with collagen sponge

Evaluation of the effect of using a composite dressing in combination with a collagen sponge on controlling bleeding and pain at the palatal donor site, compared to the use of a collagen sponge alone.

A randomized, double-blind, controlled clinical trial with parallel groups will be conducted on 40 patients, using permuted block randomization.

This randomized, double-blind trial at Mashhad Dental School will assign eligible patients who sign the informed consent form, to either the intervention (composite dressing + collagen sponge) or control group (collagen sponge alone). A blinded assessor will record palatal wound management time. Patients will report daily pain and delayed bleeding via Visual Analogue Scale for 7 days post surgery. After one week, analgesic intake (mg), discomfort, chewing difficulty, stress, and willingness to treat will be assessed using Visual Analogue Scaleby a blinded evaluator.

Inclusion Criteria: Patients with mucogingival defects requiring graft surgery, Palatal soft tissue thickness ≥ 2 mm, Palatal vault depth ≥ 12 mm. Exclusion Criteria: Any medical contraindications or systemic conditions affecting periodontium, Smoking, alcohol use, plaque index > 20%, Known allergies, prior palatal autogenous graft harvesting, Palatal lesions or use of maxillary palatal appliances/dentures.

In the control group, a collagen sponge alone will be applied to the palatal donor site and in the intervention group, both a collagen sponge and a composite shield will be used to manage bleeding and pain at the donor site.

Pain measurement based on the Visual Analogue Scale index and the amount of ibuprofen consumed by the patient during the first week after surgery (mg)

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.

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.

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.

The data access period will begin 6 months after the publication of the study results.

Academic researchers

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.

The data can be shared upon request via email at z.moslehi99@gmail.com

The data will be provided within a short period after the request is received.