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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05386667
Other study ID # 05.03.2019/05
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 5, 2019
Est. completion date March 15, 2022

Study information

Verified date May 2022
Source Pamukkale University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

In our study, three different medicaments were evaluated in terms of postoperative complications after free gingival grafting (FGG).


Description:

In our study, three different medicaments were evaluated in terms of postoperative complications after free gingival grafting. The effectiveness of these 3 different commercially available agents containing flurbiprofen, hyaluronic acid, and hypochlorous acid, after use 2., 4.7. and on the 14th day, wound healing and pain perception was compared with the control group. primary observation was obtained by visual analog scale, wound healing index, bleeding of tissue, color match, and amount of painkiller used by the patient were also recorded


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date March 15, 2022
Est. primary completion date March 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:- Patients with systematic conditions are classified as The American Society of Anesthesiologists Class I - Exclusion Criteria: - Pregnancy, lactation, and taking contraceptive pills. - Oversensitivity or anaphylactic reactions which contraindicate the intervention. - Orofacial neurological symptoms. - Infections at operation zone. - Psychotropic medicine, sedative, or non-steroid anti-inflammatory drugs use which can alter the sense of pain. - Pathological mental conditions (dementia, psychosis) and lack of cooperation. - Smoking - Excessive gag reflex - Operations are carried out with conscious sedation. - Patients who do not want to sign consent.

Study Design


Intervention

Drug:
Majezik %0.25 oral spray
Free gingival graft was taken from the palatal mucosa of the patients in order to increase the attached gingiva. After FGG, the patients were asked to apply this spray to the palatal mucosa 3 times a day.
Other:
Aftamed oral spray
Free gingival graft was taken from the palatal mucosa of the patients in order to increase the attached gingiva. After FGG, the patients were asked to apply this spray to the palatal mucosa 3 times a day.
Crystalin oral spray
Free gingival graft was taken from the palatal mucosa of the patients in order to increase the attached gingiva. After FGG, the patients were asked to apply this spray to the palatal mucosa 3 times a day.
Procedure:
Free gingival graft harvesting
Free gingival graft was taken from the palatal mucosa of the patients in order to increase the attached gingiva.

Locations

Country Name City State
Turkey Pamukkale University Faculty of Dentistry Department of Periodontology Denizli

Sponsors (1)

Lead Sponsor Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Hassan A, Ahmed E, Ghalwash D, Elarab AE. Clinical Comparison of MEBO and Hyaluronic Acid Gel in the Management of Pain after Free Gingival Graft Harvesting: A Randomized Clinical Trial. Int J Dent. 2021 Aug 14;2021:2548665. doi: 10.1155/2021/2548665. eCollection 2021. — View Citation

Isler SC, Eraydin N, Akkale H, Ozdemir B. Oral flurbiprofen spray for mucosal graft harvesting at the palatal area: A randomized placebo-controlled study. J Periodontol. 2018 Oct;89(10):1174-1183. doi: 10.1002/JPER.17-0381. Epub 2018 Aug 29. — View Citation

Yildirim S, Özener HÖ, Dogan B, Kuru B. Effect of topically applied hyaluronic acid on pain and palatal epithelial wound healing: An examiner-masked, randomized, controlled clinical trial. J Periodontol. 2018 Jan;89(1):36-45. doi: 10.1902/jop.2017.170105. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Landry's Wound Healing Index (WHI) WHI was performed on the basis of postoperative healing characteristics categorized as tissue color, response to palpation, incision margins, and suppuration. 21 days
Secondary Visual Analogue Scale Recording the pain perception of the patients on a scale from 0 to 10. 0 - no pain 10 - worst pain 21 days
Secondary Color match scoring the color match of the healed tissue area with the patient's remaining tissue 21 days
Secondary delayed bleeding examining the patient whether there is postoperative bleeding, if there is a positive, if not, it should be recorded as negative. 21 days
Secondary burning sensation Evaluation of the burning sensation felt in the healing area of the patient's palate from 0 to 10. 0-no burning sensation 10- excessive burning 21 days
Secondary complete epithelization Examination of epithelialization with 3% oxygenated water. keeping records according to the foaming rate in the tissue 21 days
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