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Impact of Preoperative Anxiety on Postoperative Quality of Life After Free Gingival Graft Surgery

Multidimensional Assessment of Preoperative Anxiety and Quality of Life on Postoperative Patient-Reported Outcomes Following Free Gingival Graft Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07258472
Acronym
FGG-QoL
Enrollment
36
Registered
2025-12-02
Start date
2016-08-31
Completion date
2017-05-31
Last updated
2025-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Anxiety, Gingival Recession, Quality of Life

Keywords

free gingival graft, Oral Health-Related Quality of Life (OHRQoL), State-Trait Anxiety Inventory (STAI), Patient-Reported Outcomes

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREFree Gingival Graft (FGG) Surgery

Sponsors

Istanbul Aydın University
CollaboratorOTHER
Istanbul Gelisim University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Single-arm interventional study in which all participants undergo free gingival graft surgery and are evaluated for preoperative anxiety, postoperative pain, and quality of life outcomes.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

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 *

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Oral Health Impact Profile-14 (OHIP-14) Total ScoreBaseline, Day 1-7, and 1 month after surgeryOral 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 ChangesBaseline and 1 month after surgeryCorrelation 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)

Secondary

MeasureTime frameDescription
Analgesic Consumption During the First Postoperative WeekDay 1-7 after surgeryParticipants recorded the number of analgesic tablets taken each day during the first postoperative week. Total analgesic consumption will be calculated as the sum of doses taken over 7 days. Unit of Measure: Number of tablets per week
Postoperative Pain Intensity (VAS)Day 1-7 after surgeryPostoperative pain intensity will be assessed daily during the first postoperative week using a 100-mm Visual Analog Scale (VAS), where 0 represents no pain and 100 represents the worst imaginable pain. Higher scores indicate greater pain intensity. Unit of Measure: Score (0-100 mm)
Plaque Index Score (Silness-Löe)Baseline and 1 month postoperativelyPlaque Index (Silness-Löe) scores will be recorded at baseline and 1 month after surgery to evaluate plaque accumulation around the treated sites. Each surface is scored from 0 to 3, where 0 indicates no plaque and 3 indicates abundant soft deposits. Higher scores indicate greater plaque accumulation. Unit of Measure: Score (0-3)
Gingival Index Score (Löe-Silness)Baseline and 1 month postoperativelyGingival Index (Löe-Silness) scores will be recorded at baseline and 1 month after surgery to evaluate gingival inflammation around the treated sites. Each surface is scored from 0 to 3, where 0 indicates normal gingiva and 3 indicates severe inflammation with ulceration or spontaneous bleeding. Higher scores indicate more severe gingival inflammation. Unit of Measure: Score (0-3)
Keratinized Tissue Width (mm)Baseline and 1 month postoperatively.Description: The width of keratinized tissue will be measured in millimeters using a periodontal probe from the gingival margin to the mucogingival junction at baseline and 1 month after free gingival graft surgery. Unit of Measure: Millimeters (mm)
Correlation Between OHIP-14 Scores and Demographic and Surgical FactorsBaseline, Day 1-7, and 1 month after surgeryCorrelation analyses will be performed to evaluate the relationship between postoperative OHIP-14 total scores and demographic (age, gender, education, marital status, smoking status) and surgical factors (graft dimensions, recipient site dimensions, operation duration). Unit of Measure: Correlation coefficient (r)

Other

MeasureTime frameDescription
Surgery DurationAt surgeryThe duration of surgery will be recorded in minutes, measured from the first incision until placement of the final suture using a stopwatch. Unit of Measure: Minutes (min)
Graft Thickness (GT)At surgery (baseline)Description: The graft thickness will be measured in millimeters using a manual caliper at the mid-point of the harvested graft during surgery. Unit of Measure: Millimeters (mm)
Recipient Site Dimensions (Horizontal Width and Vertical Depth)At surgery (baseline)The recipient site horizontal width (RHW) will be measured as the widest mesio-distal distance, and the recipient site vertical depth (RVD) as the deepest apico-coronal distance, using a manual caliper during surgery. Unit of Measure: Millimeters (mm)
Graft Dimensions (Vertical Height and Horizontal Width)At surgery (baseline)The vertical height (GVH) and horizontal width (GHW) of the free gingival graft will be measured in millimeters during surgery using a manual caliper. The graft vertical height will be recorded as the apico-coronal dimension, and the horizontal width as the mesio-distal dimension of the harvested graft. Unit of Measure: Millimeters (mm)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026