The Impact of Free Gingival Grafts on Patient Satisfaction

Not Applicable

Completed

• Conditions: Free Gingival Graft; Patient Satisfaction

• Registration Number: NCT07167901
• Lead Sponsor: Istanbul Gelisim University

Brief Summary

This study compares the effects of free gingival graft (FGG) surgery on prosthetically restored and non-restored teeth regarding patients' oral quality of life using various scales. Patients with insufficient attached gingiva who are indicated for free gingival graft surgery will be included in this study. We will collect demographic data, including age, gender for all patients who meet the inclusion criteria. Prior to the surgery, all patients will have their oral periodontal indices and their scores on the Oral Health Impact Profile-14 (OHIP-14) recorded. All patients will undergo free gingival graft surgery using the same surgical technique, and we will record operation details such as graft dimensions and the location of the recipient bed. The OHIP-14 will be completed three times: once one day, one week, and again one month after the surgery. Additionally, a satisfaction questionnaire will be administered one month post-operation, and a visual analog scale (VAS) for pain will be collected during one week after the surgery. Following statistical analysis of the collected data, we will report on the impact of the free gingival graft surgery on oral health-related quality of life. The distribution of OHIP-14 scores, satisfaction survey results, and VAS pain scale data will be analyzed in relation to demographic characteristics and their association with surgical data.

Detailed Description

This clinical study is designed to evaluate the impact of free gingival graft (FGG) surgery on oral health-related quality of life in patients with insufficient attached gingiva. Participants will be recruited from the Departments of Periodontology at Istanbul Gelişim University and Kütahya Health Sciences University.

All participants will receive phase I periodontal treatment and oral hygiene instructions prior to surgery. After a four-week healing period, FGG surgery will be performed using a standardized surgical technique. Surgical data, including graft dimensions and recipient site location, will be recorded during the procedure.

Participants will be categorized into two groups based on the presence or absence of prosthetic restoration on the treated tooth:

Group 1: Non-restored teeth

Group 2: Prosthetically restored teeth

Clinical periodontal indices will be assessed at baseline and postoperatively. Oral health-related quality of life will be evaluated using the OHIP-14 questionnaire administered at baseline, one day, one week, and one month following surgery. Patient-reported outcomes will include a satisfaction questionnaire at one month and a visual analog scale (VAS) for postoperative pain during the first week. The number of analgesics consumed will also be recorded.

The primary objective is to compare changes in OHIP-14 scores between groups over time. Secondary outcomes include postoperative pain, patient satisfaction, and the association of clinical and surgical parameters with quality of life measures.

Data will be analyzed using descriptive and inferential statistics. Normality of distribution will be tested, and comparisons between repeated measures and groups will be conducted with appropriate parametric or non-parametric tests. Correlation analyses will be performed to examine relationships between clinical, surgical, and patient-reported variables. The calculated sample size is 49 participants, accounting for potential dropouts.

Study Timeline

• Study Start: 2024-10-21
• Primary Completion: 2025-05-30
• Study Completion: 2025-05-30
• Study First Submitted: 2025-07-09
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-04
• Last Update Submitted: 2025-09-04
• Study First Posted: 2025-09-11
• Last Update Posted: 2025-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• Being between the ages of 18-65
• The patient does not have any systemic disease
• The patient is cooperative
• Patients with keratinized mucosa deficiency or insufficiency (less than 1 mm)

Exclusion Criteria

• regnant and breastfeeding patients
• Mentally retarded patients
• Patients who smoke more than 10 cigarettes per day
• Patients with bleeding disorders or anticoagulant medication use
• Patients who use medications that suppress the immune system or impair healing
• Patients who do not answer the questions in a timely manner and cannot cooperate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Oral health impact profile- 14 Scale	Before FGG surgery and After 1 day, 1 week, and 1 month	Oral health impact profile- 14 Scale OHIP-14 questionnaire: OHIP-14 consists of 14 questions and Likert scale is used (0=Never, 1=Rarely, 2=Sometimes, 3=Frequently and 4=Always). In the evaluation of OHIP-14, scoring is done separately in 7 categories under the main titles of functional limitation, physical pain, psychological discomfort, physical disability, psychological disability and handicap and the total score obtained by the sum of all these category scores
Satisfaction questionnaire	1 month after the sugery	The satisfaction survey consists of 13 questions and is answered as yes or no. The patient's level of satisfaction with the treatment will be assessed with a 13-question survey asked 1 month after the Free Gingival Graft treatment.

Secondary Outcome Measures

Name	Time	Method
VAS pain scale	1 week during after the surgery	VAS VISUAL ANALOG SCALE (VAS) PAIN SCALE: The post-operative pain levels of the patients will be evaluated with the VAS pain scale. The pain felt will be marked on the VAS pain scale. On the horizontal scale, 0 means no pain, and 100 means unbearable pain.
Number of painkillers used	1 week during after the surgery	Number of painkillers used
Clinical periodontal index	Before FGG surgery and 1 month after the sugery	Clinical periodontal measurements are given below. Plaque index Gingival index Bleeding index on probing Pocket depth Clinical attachment level Keratinized gingival width
Operational data	On the surgery	Graft width (mm) Graft length (mm) Graft thickness(mm) Graft volume (Graft width x Graft length x Graft thickness ) Recipient bed location (maxilla-mandible, anterior-posterior)

Trial Locations

Locations (1)

Istanbul Gelisim University; Istanbul, Turkey (Türkiye)