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

NCT07258472 | Completed

• 1 other identifier: B.30.2.AYD.0.00.00-480.2/130
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Recession; Dental Anxiety; Quality of Life

Keywords

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

Outcome Measures

Primary Outcomes (2)

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

  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

  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 Outcomes (6)

• 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

Other Outcomes (4)

• Graft Dimensions (Vertical Height and Horizontal Width)

  At surgery (baseline)

• Graft Thickness (GT)

  At surgery (baseline)

• Recipient Site Dimensions (Horizontal Width and Vertical Depth)

  At surgery (baseline)

Study Arms (1)

Free Gingival Graft (FGG) Surgery

EXPERIMENTAL

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

Interventions

Free Gingival Graft (FGG) Surgery PROCEDURE

Free Gingival Graft (FGG) Surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Gelisim University: lead
• Istanbul Aydın University: collaborator

Study Sites (1)

Istanbul Gelisim University

Istanbul, 34315, Turkey (Türkiye)

Location

Related Publications (9)

• Zucchelli G, Tavelli L, McGuire MK, Rasperini G, Feinberg SE, Wang HL, Giannobile WV. Autogenous soft tissue grafting for periodontal and peri-implant plastic surgical reconstruction. J Periodontol. 2020 Jan;91(1):9-16. doi: 10.1002/JPER.19-0350. Epub 2019 Oct 6.

  PMID: 31461778 BACKGROUND

• Bitencourt FV, Cardoso De David S, Schutz JDS, Otto Kirst Neto A, Visioli F, Fiorini T. Minimizing patient morbidity after free gingival graft harvesting:A triple-blind randomized-controlled clinical trial. Clin Oral Implants Res. 2022 Jun;33(6):622-633. doi: 10.1111/clr.13923. Epub 2022 Apr 6.

  PMID: 35305280 RESULT

• Mounssif I, Bentivogli V, Rendon A, Gissi DB, Maiani F, Mazzotti C, Mele M, Sangiorgi M, Zucchelli G, Stefanini M. Patient-reported outcome measures after periodontal surgery. Clin Oral Investig. 2023 Dec;27(12):7715-7724. doi: 10.1007/s00784-023-05362-y. Epub 2023 Nov 9.

  PMID: 37940683 RESULT

• Zucchelli G, Mounssif I, Mazzotti C, Montebugnoli L, Sangiorgi M, Mele M, Stefanini M. Does the dimension of the graft influence patient morbidity and root coverage outcomes? A randomized controlled clinical trial. J Clin Periodontol. 2014 Jul;41(7):708-16. doi: 10.1111/jcpe.12256. Epub 2014 May 8.

  PMID: 24708394 RESULT

• Ozcelik O, Haytac MC, Seydaoglu G. Immediate post-operative effects of different periodontal treatment modalities on oral health-related quality of life: a randomized clinical trial. J Clin Periodontol. 2007 Sep;34(9):788-96. doi: 10.1111/j.1600-051X.2007.01120.x.

  PMID: 17716314 RESULT

• Fardal O, McCulloch CA. Impact of anxiety on pain perception associated with periodontal and implant surgery in a private practice. J Periodontol. 2012 Sep;83(9):1079-85. doi: 10.1902/jop.2011.110562. Epub 2011 Dec 19.

  PMID: 22181682 RESULT

• Croog SH, Baume RM, Nalbandian J. Pre-surgery psychological characteristics, pain response, and activities impairment in female patients with repeated periodontal surgery. J Psychosom Res. 1995 Jan;39(1):39-51. doi: 10.1016/0022-3999(94)00089-n.

  PMID: 7760302 RESULT

• McGrath C, Bedi R. The association between dental anxiety and oral health-related quality of life in Britain. Community Dent Oral Epidemiol. 2004 Feb;32(1):67-72. doi: 10.1111/j.1600-0528.2004.00119.x.

  PMID: 14961842 RESULT

• Sen DO, Sengul BI, Yarkac FU, Oncu E. Impact of platelet-rich fibrin derivatives on patient morbidity and quality of life in palatal donor sites following free gingival graft surgery: a randomized clinical trial. Clin Oral Investig. 2024 Nov 7;28(12):631. doi: 10.1007/s00784-024-06023-4.

  PMID: 39505777 RESULT

MeSH Terms

Conditions

Gingival Recession

Interventions

fibrinopeptides gamma; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• serap karakış akcan, DDS,PhD

  stanbul Gelişim University, Faculty of Dentistry, Department of Periodontology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor doctor, DDS, PhD

Model Details: 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.

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: December 2, 2025
• Study Start: August 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)