The Evaluation of Free Gingival Graft Operations Around Implant or Teeth on Quality of Life

Not Applicable

Completed

• Conditions: Patient Reported Outcome
• Interventions: Procedure: Free Gingival Graft

• Registration Number: NCT04813081
• Lead Sponsor: University of Beykent

Brief Summary

The purpose of this study is to evaluate the quality of life of patients who underwent FGG surgery around the natural tooth and as a second surgery after the implant operation, in comparison with general oral health assesment index(GOHAI).

Detailed Description

Thirty-two participants were included who were referred to the periodontology clinic suffering insufficient keratinized gingiva / mucosa deficiency around the implant and / or tooth/teeth. GOHAI-total and GOHAI psychological impact, functional limitation, pain and discomfort, behavioral impact subcategories were recorded at before and postoperative first week and 30th day. Also, satisfaction questionnaires, number of painkillers and visual analog scale values were recorded.

Study Timeline

• Study Start: 2017-05-01
• Primary Completion: 2019-01-31
• Study Completion: 2019-03-04
• Status Verified: 2021-03
• Study First Submitted: 2021-03-18
• Study First Submitted QC: 2021-03-23
• Last Update Submitted: 2021-03-23
• Study First Posted: 2021-03-24
• Last Update Posted: 2021-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Non-smoking
• Teeth and implants with keratinized gingiva width <1 mm
• A healthy periodontal and peri-implant condition
• Patients who didn't have ever experience periodontal surgery had first oral surgery experience with dental FGG operation for the first time
• Patients who underwent implant surgery for the first oral surgery experience
• Maximum two teeth/implants on recipient area

Exclusion Criteria

• Patients receiving any medication to disrupt wound healing
• Lactation or pregnancy
• Caries or defects on the tooth root surface
• Periapical lesion in the recipient area active periodontal disease
• Patients who have previously had periodontal or oral surgery experiences

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Free gingival graft around dental implant patients	Free Gingival Graft	Test Group (TG) consists of patients have free gingival graft around dental implant patients
Free gingival graft around the teeth	Free Gingival Graft	Control Group (CG) consists of patients have free gingival graft around the teeth.

Primary Outcome Measures

Name	Time	Method
General Oral Health Assesment Index (GOHAI) scores- intragroup comparisons change between from baseline to other follow-up times and intergroup comparisons all follow-up times	Baseline, postoperative 1., 2., 3., 4., 5., 6. and 7. days and first month.	The questions that contains 12 items and that give subcategorized about functional limitations, pain and discomfort, psychological impacts, and behavioral impact.

Secondary Outcome Measures

Name	Time	Method
Age	baseline	18-65 years

Trial Locations

Locations (1)

Beykent University Faculty of Dentistry; 🇹🇷 Istanbul, Turkey