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

I

Istanbul Gelisim University

Status

Completed

Conditions

Dental Anxiety
Quality of Life
Gingival Recession

Treatments

Procedure: Free Gingival Graft (FGG) Surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT07258472
B.30.2.AYD.0.00.00-480.2/130

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Health Services Research

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

36 participants in 1 patient group

Free Gingival Graft (FGG) Surgery
Experimental group
Description:
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.
Treatment:
Procedure: Free Gingival Graft (FGG) Surgery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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