The Impact of Free Gingival Grafts on Patient Satisfaction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Oral health impact profile- 14 Scale
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Oral health impact profile- 14 Scale
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Serap Karakış Akcan
Asst. Prof
Istanbul Gelisim University