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Gingival RecessionFGG-QoLNCT07258472

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

A study testing Free Gingival Graft (FGG) Surgery in people with Gingival Recession and Dental Anxiety, run by Istanbul Gelisim University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
Free Gingival Graft (FGG) Surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteTurkey (Türkiye)
Study dates
Aug 2016to May 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • No bleeding disorders
  • Not taking medications that could interfere with wound healing
  • Provided complete responses to all follow-up questionnaires

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul Gelisim University

    Istanbul, 34315

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
Free Gingival Graft (FGG) Surgery
Keywords
free gingival graft, Oral Health-Related Quality of Life (OHRQoL), State-Trait Anxiety Inventory (STAI), Patient-Reported Outcomes
Medical subject headings
Gingival Recession

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Free Gingival Graft (FGG) SurgeryProcedure or surgery

Study groups in NCT07258472
Study groupRoleWhat they receive
Free Gingival Graft (FGG) SurgeryExperimentalAll 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.
Receives: Procedure: Free Gingival Graft (FGG) Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Baseline, Day 1-7, and 1 month after surgery

  2. 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)

    Measured: Baseline and 1 month after surgery

Secondary outcomes (6)
  1. Correlation Between OHIP-14 Scores and Demographic and Surgical Factors

    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)

    Measured: Baseline, Day 1-7, and 1 month after surgery

  2. Postoperative Pain Intensity (VAS)

    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)

    Measured: Day 1-7 after surgery

  3. Analgesic Consumption During the First Postoperative Week

    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

    Measured: Day 1-7 after surgery

  4. Plaque Index Score (Silness-Löe)

    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)

    Measured: Baseline and 1 month postoperatively

  5. Gingival Index Score (Löe-Silness)

    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)

    Measured: Baseline and 1 month postoperatively

  6. Keratinized Tissue Width (mm)

    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)

    Measured: Baseline and 1 month postoperatively.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2025
  2. Study startAug 2016
  3. Primary completionMay 2017
  4. Study completionMay 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
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.
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07258472
Sponsor's protocol ID
B.30.2.AYD.0.00.00-480.2/130
Acronym
FGG-QoL
Status last verified
Nov 2025
First submitted
4 Sep 2025
Last updated
2 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared.

Publications

  • 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.

    PubMed 31461778
  • 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.

    PubMed 35305280
  • 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.

    PubMed 37940683
  • 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.

    PubMed 24708394
  • 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.

    PubMed 17716314
  • 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.

    PubMed 22181682
  • 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.

    PubMed 7760302
  • 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.

    PubMed 14961842
  • 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.

    PubMed 39505777

Questions about this trial

What is this clinical trial studying?

A study testing Free Gingival Graft (FGG) Surgery in people with Gingival Recession and Dental Anxiety, run by Istanbul Gelisim University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Oral Health Impact Profile-14 (OHIP-14) Total Score (time frame: Baseline, Day 1-7, and 1 month after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07258472, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.

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