Clinical trial NCT05386667: Evaluation of the Effects of Medicaments Used After Free Gingival Graft on Postoperative Complications.
Official title: Evaluation of the Effects of Medicaments Used After Free Gingival Graft on Postoperative Complications.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Healing Wound
Hemorrhage
Analgesia
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population of the study consists of all patients, who were planned to be applied free gingival graft for mucogingival surgery

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

Detailed 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

Eligibility criteria: Inclusion Criteria:- Patients with systematic conditions are classified as The American Society of Anesthesiologists Class I

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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.

Primary outcomes:
measure: Landry's Wound Healing Index (WHI)
timeFrame: 21 days
Secondary outcomes:
measure: Visual Analogue Scale
timeFrame: 21 days
measure: Color match
timeFrame: 21 days
measure: delayed bleeding
timeFrame: 21 days
measure: burning sensation
timeFrame: 21 days
measure: complete epithelization
timeFrame: 21 days
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University Faculty of Dentistry Department of Periodontology
Study officials:
affiliation: Pamukkale Univesity
name: AYSAN LEKTEMUR ALPAN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: Yildirim S, Ozener HO, 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.