Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2025-12-24 @ 5:52 PM
NCT ID:
NCT03293368
Brief Summary:
After signing the informed consent, the participant will be allocated to either intervention or control group, then each participant in the intervention group will receive intralesional injections of platelet rich plasma extracted from their own blood in each visit as following:
1. 12 ml of blood will be assembled from the veins of antecubital fossa
2. PRP preparation will be done according to Mostafa et al., 2013
3. 0.5 ml of PRP will be injected per 1 cm2 of ulcerated mucosa
The second group will receive triamcinolone acetonide 40 mg injected 1 ml per 1 cm2 of ulcerated mucosa
Both groups will receive a total of 4 injection, the injections will be carried out once a week.
Pain, lesions size and remission time are the outcomes will be assessed using a numerical rating scale (Seymour, 1982), clinical score according to Thongprasom et al., 1992 and binary scale for remission time according to Conrotto et al., 2006, respectively.
Assessment of the outcomes will be carried before the trial (baseline records) and before receiving the treatment in each visit by the primary investigator (H.A.) and the blinded assessor (Dr. A.W.) separately.
Each participant will have a total of 11 visits during the trial, 5 visits will be once every week during the trial and every 2 weeks for 3 months treatment free.
Study:
NCT03293368
Study Brief:
Protocol Section:
NCT03293368