The Impact of Free Gingival Grafts on Patient Satisfaction

NCT07167901 | Completed

• 1 other identifier: 2024-16-79
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Free Gingival Graft; Patient Satisfaction

Outcome Measures

Primary Outcomes (2)

• Oral health impact profile- 14 Scale

  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

  Before FGG surgery and After 1 day, 1 week, and 1 month

• Satisfaction questionnaire

  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.

  1 month after the sugery

Secondary Outcomes (4)

• VAS pain scale

  1 week during after the surgery

• Number of painkillers used

  1 week during after the surgery

• Clinical periodontal index

  Before FGG surgery and 1 month after the sugery

• Operational data

  On the surgery

Study Arms (2)

Prosthetically restored teeth

EXPERIMENTAL

Prosthetically restored teeth will also be included in this group. Free gingival graft surgery will be performed

Procedure: Free Gingival Graft

Non-restored teeth

EXPERIMENTAL

Non-restored teeth will also be included in this group. Free gingival graft surgery will be performed

Procedure: Free Gingival Graft

Interventions

Free Gingival Graft PROCEDURE

All patients will undergo free gingival graft surgery by the same surgeon using the same surgical protocol.

Non-restored teeth; Prosthetically restored teeth

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Gelisim University: lead

Study Sites (1)

Istanbul Gelisim University

Istanbul, 34315, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof

Model Details: parallel clinical prospective study

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: September 11, 2025
• Study Start: October 21, 2024
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)