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

Completed

• Conditions: Hemorrhage; Pain, Postoperative; Healing Wound; Analgesia
• Interventions: Procedure: Free gingival graft harvesting; Drug: Majezik %0.25 oral spray; Other: Crystalin oral spray; Other: Aftamed oral spray

• Registration Number: NCT05386667
• Lead Sponsor: Pamukkale University

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

Study Timeline

• Study Start: 2019-03-05
• Primary Completion: 2022-03-15
• Study Completion: 2022-03-15
• Status Verified: 2022-05
• Study First Submitted: 2022-05-18
• Study First Submitted QC: 2022-05-18
• Last Update Submitted: 2022-05-18
• Study First Posted: 2022-05-23
• Last Update Posted: 2022-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Free gingival graft harvesting	Patients were not given anything after FGG.
Flurbiprofen	Majezik %0.25 oral spray	Oral spray containing 0.075 g flurbiprofen administered after FGG
Flurbiprofen	Free gingival graft harvesting	Oral spray containing 0.075 g flurbiprofen administered after FGG
Hypochlorous acid	Crystalin oral spray	Oral spray containing hypochlorous acid applied after FGG
Hypochlorous acid	Free gingival graft harvesting	Oral spray containing hypochlorous acid applied after FGG
Hyaluronic acid	Aftamed oral spray	An oral spray containing the main component of the product is hyaluronic acid (sodium salt) with a high molecular weight of 30 mg / 100 g was given to patients after FGG
Hyaluronic acid	Free gingival graft harvesting	An oral spray containing the main component of the product is hyaluronic acid (sodium salt) with a high molecular weight of 30 mg / 100 g was given to patients after FGG

Primary Outcome Measures

Name	Time	Method
Landry's Wound Healing Index (WHI)	21 days	WHI was performed on the basis of postoperative healing characteristics categorized as tissue color, response to palpation, incision margins, and suppuration.

Secondary Outcome Measures

Name	Time	Method
Visual Analogue Scale	21 days	Recording the pain perception of the patients on a scale from 0 to 10. 0 - no pain 10 - worst pain
Color match	21 days	scoring the color match of the healed tissue area with the patient's remaining tissue
delayed bleeding	21 days	examining the patient whether there is postoperative bleeding, if there is a positive, if not, it should be recorded as negative.
burning sensation	21 days	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
complete epithelization	21 days	Examination of epithelialization with 3% oxygenated water. keeping records according to the foaming rate in the tissue

Trial Locations

Locations (1)

Pamukkale University Faculty of Dentistry Department of Periodontology; 🇹🇷 Denizli, Turkey