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

Study Overview
=================
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.

Official Title
-----------------
The Evaluation of Free Gingival Graft Operations Around Implant or Teeth on Quality of Life: Parallel-controlled Prospective Clinical Trial

Conditions
-----------------
Patient Reported Outcome

Intervention / Treatment
-----------------
* Procedure: Free Gingival Graft


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The participants were defined as two study groups: Test Group (TG) consists of patients have free gingival graft around dental implant patients and Control Group (CG) consists of patients have free gingival graft around the teeth.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Free gingival graft around dental implant patients<br>Test Group (TG) consists of patients have free gingival graft around dental implant patients | Procedure: Free Gingival Graft<br>* In the recipient area, a half-thickness flap with two vertical incision widths was removed with a horizontal incision with 15C blades from the mucogingival junction. The recipient site was determined such that one or two teeth or one tooth extends into the mesial and distal regions of the tooth. Muscle attachments were dissected and FGG was placed on recipient bed and non-resorbable monofilament sutures were used for fixing the four corners of the graft.<br>|
| Active Comparator: Free gingival graft around the teeth<br>Control Group (CG) consists of patients have free gingival graft around the teeth. | Procedure: Free Gingival Graft<br>* In the recipient area, a half-thickness flap with two vertical incision widths was removed with a horizontal incision with 15C blades from the mucogingival junction. The recipient site was determined such that one or two teeth or one tooth extends into the mesial and distal regions of the tooth. Muscle attachments were dissected and FGG was placed on recipient bed and non-resorbable monofilament sutures were used for fixing the four corners of the graft.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | The questions that contains 12 items and that give subcategorized about functional limitations, pain and discomfort, psychological impacts, and behavioral impact. | Baseline, postoperative 1., 2., 3., 4., 5., 6. and 7. days and first month. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age | 18-65 years | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
quality of life, graft