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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.
Full 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.
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49 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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