Evaluation of the Effects of Medicaments Used After Free Gingival Graft on Postoperative Complications.

Pain, Postoperative Clinical Trial

Official title:

Evaluation of the Effects of Medicaments Used After Free Gingival Graft on Postoperative Complications.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05386667
• Other study ID #: 05.03.2019/05
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Analgesia
• Healing Wound
• Hemorrhage
• Pain, Postoperative
• Postoperative Complications

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