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NCT Number: NCT07258472

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

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.

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Key information

Conditions

Gingival Recession Dental Anxiety Gingival Diseases Mouth Diseases Periodontal Atrophy Periodontal Diseases Quality of Life Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Gelisim University

Istanbul, 34315, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Free Gingival Graft (FGG) Surgery

Procedure

Primary outcomes

  1. Change in Oral Health Impact Profile-14 (OHIP-14) Total Score

    Time frame: 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)

  2. Correlation Between Preoperative Anxiety Levels (STAI-S and STAI-T) and Postoperative OHIP-14 Score Changes

    Time frame: 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)

Secondary outcomes

  1. Correlation Between OHIP-14 Scores and Demographic and Surgical Factors

    Time frame: Baseline, Day 1-7, and 1 month after surgery

    Correlation 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)

  2. Postoperative Pain Intensity (VAS)

    Time frame: Day 1-7 after surgery

    Postoperative 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)

  3. Analgesic Consumption During the First Postoperative Week

    Time frame: Day 1-7 after surgery

    Participants 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

  4. Plaque Index Score (Silness-Löe)

    Time frame: Baseline and 1 month postoperatively

    Plaque 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)

  5. Gingival Index Score (Löe-Silness)

    Time frame: Baseline and 1 month postoperatively

    Gingival 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)

  6. Keratinized Tissue Width (mm)

    Time frame: 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)

Other outcomes

  1. Graft Dimensions (Vertical Height and Horizontal Width)

    Time frame: 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)

  2. Graft Thickness (GT)

    Time frame: 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)

  3. Recipient Site Dimensions (Horizontal Width and Vertical Depth)

    Time frame: 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)

  4. Surgery Duration

    Time frame: At surgery

    The 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)

Sponsors and collaborators

Lead sponsor

Istanbul Gelisim University

Other

Collaborators

  • Istanbul Aydın University

Registry information

Official study title

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

Acronym: FGG-QoL

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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