Multidimensional Assessment of Preoperative Anxiety and Quality of Life on Postoperative Patient-Reported Outcomes Following Free Gingival Graft Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in Oral Health Impact Profile-14 (OHIP-14) Total Score
研究概览
简要总结
This study investigates the effect of free gingival graft (FGG) surgery on patients' oral health-related quality of life (QoL) during the first postoperative month and evaluates the role of preoperative anxiety on postoperative QoL outcomes. Thirty-six participants indicated for FGG surgery due to insufficient keratinized gingiva were included. The Oral Health Impact Profile-14 (OHIP-14) was administered preoperatively, daily during the first postoperative week, and at one month. Preoperative anxiety levels were assessed using the State-Trait Anxiety Inventory (STAI-S and STAI-T). Postoperative pain was evaluated with the Visual Analog Scale (VAS) for seven days. Demographic and lifestyle variables, including age, gender, educational status, marital status, and smoking status, were recorded. Clinical parameters such as plaque and gingival indices and keratinized tissue width were measured preoperatively and one month postoperatively. Intraoperative surgical data, including graft vertical height, horizontal width, thickness, and recipient site dimensions, were documented. Statistical analysis will determine the relationship between preoperative anxiety and postoperative QoL, as well as the influence of surgical and demographic factors on patient-reported outcomes.
详细描述
Free gingival graft (FGG) procedures are widely used to increase keratinized gingiva and manage mucogingival problems. Despite predictable clinical outcomes, these surgeries are associated with postoperative discomfort, donor site morbidity, and aesthetic limitations that may negatively affect patient quality of life (QoL). Preoperative anxiety is also considered an important factor influencing postoperative pain perception and recovery.
This prospective clinical study was conducted between August 2016 and May 2017 to evaluate the effect of FGG surgery on oral health-related quality of life (OHQoL) and to investigate the relationship between preoperative anxiety and postoperative outcomes. Thirty-six participants who met the eligibility criteria underwent FGG surgery following phase I periodontal therapy.
Preoperative assessments included demographic data, plaque index, gingival index, keratinized tissue width, and anxiety levels measured using the State-Trait Anxiety Inventory (STAI-S and STAI-T). The OHIP-14 questionnaire was completed one week before surgery, on the day of surgery, daily for the first seven postoperative days, and at one month.
Intraoperative variables recorded included graft vertical height, horizontal width, thickness, and recipient site dimensions. Postoperative assessments included OHIP-14 scores, Visual Analog Scale (VAS) scores for pain collected daily for seven days, the number of analgesics used, and clinical measurements of gingival indices and keratinized tissue width at one month.
The primary outcome is the change in OHIP-14 scores over time and their association with preoperative anxiety. Secondary outcomes include postoperative pain, analgesic consumption, and the influence of surgical and demographic parameters on QoL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- 是
入选标准
- •Age between 18 and 65 years
- •Systemically healthy
- •Non-smokers or smoking fewer than 10 cigarettes per day
- •Healthy periodontal and peri-implant tissues
- •Presence of ≤2 teeth or implants in the recipient area with keratinized tissue width (KTW) < 1 mm
- •Not pregnant or lactating
- •No bleeding disorders
- •Not taking medications that could interfere with wound healing
- •Provided complete responses to all follow-up questionnaires
排除标准
- •Previous history of periodontal surgical treatment
- •Difficulty reading or understanding the questionnaires
- •Failure to follow the study timeline (e.g., missed or late responses)
- •Presence of active periapical or peri-implant infection at the surgical site
研究组 & 干预措施
Free Gingival Graft (FGG) Surgery
All participants underwent free gingival graft (FGG) surgery using a standardized protocol performed by the same surgical team. Local anesthesia was administered, a half-thickness flap was prepared, and grafts harvested from the palatal donor site were secured with sutures. Postoperative care included analgesics and chlorhexidine mouth rinse. Sutures and periodontal dressing were removed at day 14.
干预措施: Free Gingival Graft (FGG) Surgery (Procedure)
结局指标
主要结局
Change in Oral Health Impact Profile-14 (OHIP-14) Total Score
时间窗: Baseline, Day 1-7, and 1 month after surgery
Oral health-related quality of life will be evaluated using the Oral Health Impact Profile-14 (OHIP-14), as derived and validated by Slade (1997, Community Dent Oral Epidemiol, 25: 284-90). Each of the 14 items is scored on a 0-5 scale (0 = never, 5 = very often), producing a total score ranging from 0 to 70. Higher scores indicate poorer oral health-related quality of life. Changes in total OHIP-14 scores will be recorded from baseline to postoperative Day 1-7 and 1 month. Unit of Measure: Score (0-70)
Correlation Between Preoperative Anxiety Levels (STAI-S and STAI-T) and Postoperative OHIP-14 Score Changes
时间窗: Baseline and 1 month after surgery
Correlation between changes in Oral Health Impact Profile-14 (OHIP-14) scores and preoperative anxiety levels will be evaluated using the State-Trait Anxiety Inventory (STAI-S for state anxiety and STAI-T for trait anxiety). Each STAI subscale ranges from 20 to 80, with higher scores indicating greater anxiety. Correlation analysis (Pearson's r or Spearman's ρ) will be performed to determine whether baseline anxiety levels are associated with postoperative changes in OHIP-14 total scores. Unit of Measure: Correlation coefficient (r)
次要结局
- Correlation Between OHIP-14 Scores and Demographic and Surgical Factors(Baseline, Day 1-7, and 1 month after surgery)
- Postoperative Pain Intensity (VAS)(Day 1-7 after surgery)
- Analgesic Consumption During the First Postoperative Week(Day 1-7 after surgery)
- Plaque Index Score (Silness-Löe)(Baseline and 1 month postoperatively)
- Gingival Index Score (Löe-Silness)(Baseline and 1 month postoperatively)
- Keratinized Tissue Width (mm)(Baseline and 1 month postoperatively.)
研究者
Serap Karakış Akcan
Assistant professor doctor, DDS, PhD
Istanbul Gelisim University