Impact of Preoperative Anxiety on Postoperative Quality of Life After Free Gingival Graft Surgery (FGG-QoL)

November 20, 2025 updated by: Serap Karakış Akcan, Istanbul Gelisim University

Multidimensional Assessment of Preoperative Anxiety and Quality of Life on Postoperative Patient-Reported Outcomes Following 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: Free Gingival Graft (FGG) Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline, Day 1-7, and 1 month after surgery
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)
Baseline and 1 month after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline, Day 1-7, and 1 month after surgery
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)
Day 1-7 after surgery
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
Day 1-7 after surgery
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)
Baseline and 1 month postoperatively
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)
Baseline and 1 month postoperatively
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)
Baseline and 1 month postoperatively.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
At surgery (baseline)
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)
At surgery (baseline)
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)
At surgery (baseline)
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)
At surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Gelisim University

Collaborators

Istanbul Aydın University

Investigators

  • Principal Investigator: serap karakış akcan, DDS,PhD, stanbul Gelişim University, Faculty of Dentistry, Department of Periodontology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

September 4, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Actual)

December 2, 2025

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B.30.2.AYD.0.00.00-480.2/130

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Quality of Life

Clinical Trials on Free Gingival Graft (FGG) Surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe