Free Gingival GraftNCT07167901
The Impact of Free Gingival Grafts on Patient Satisfaction
A study testing Free Gingival Graft in people with Free Gingival Graft and Patient Satisfaction, run by Istanbul Gelisim University at 1 site in Turkey (Türkiye).
Trial summary
This study compares the effects of free gingival graft (FGG) surgery on prosthetically restored and non-restored teeth regarding patients' oral quality of life using various scales. Patients with insufficient attached gingiva who are indicated for free gingival graft surgery will be included in this study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Free Gingival Graft, Patient Satisfaction
- What is being tested?
- Free Gingival Graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Oct 2024to 30 May 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between the ages of 18-65
- The patient does not have any systemic disease
- The patient is cooperative
- Patients with keratinized mucosa deficiency or insufficiency (less than 1 mm)
Who cannot join
- regnant and breastfeeding patients
- Mentally retarded patients
- Patients who smoke more than 10 cigarettes per day
- Patients with bleeding disorders or anticoagulant medication use
- Patients who use medications that suppress the immune system or impair healing
- Patients who do not answer the questions in a timely manner and cannot cooperate
Trial locations and contacts
1 site in 1 country.
About this study
This study compares the effects of free gingival graft (FGG) surgery on prosthetically restored and non-restored teeth regarding patients' oral quality of life using various scales. Patients with insufficient attached gingiva who are indicated for free gingival graft surgery will be included in this study. We will collect demographic data, including age, gender for all patients who meet the inclusion criteria. Prior to the surgery, all patients will have their oral periodontal indices and their scores on the Oral Health Impact Profile-14 (OHIP-14) recorded. All patients will undergo free gingival graft surgery using the same surgical technique, and we will record operation details such as graft dimensions and the location of the recipient bed. The OHIP-14 will be completed three times: once one day, one week, and again one month after the surgery. Additionally, a satisfaction questionnaire will be administered one month post-operation, and a visual analog scale (VAS) for pain will be collected during one week after the surgery. Following statistical analysis of the collected data, we will report on the impact of the free gingival graft surgery on oral health-related quality of life. The distribution of OHIP-14 scores, satisfaction survey results, and VAS pain scale data will be analyzed in relation to demographic characteristics and their association with surgical data.
Read the detailed description
This clinical study is designed to evaluate the impact of free gingival graft (FGG) surgery on oral health-related quality of life in patients with insufficient attached gingiva. Participants will be recruited from the Departments of Periodontology at Istanbul Gelişim University and Kütahya Health Sciences University.
All participants will receive phase I periodontal treatment and oral hygiene instructions prior to surgery. After a four-week healing period, FGG surgery will be performed using a standardized surgical technique. Surgical data, including graft dimensions and recipient site location, will be recorded during the procedure.
Participants will be categorized into two groups based on the presence or absence of prosthetic restoration on the treated tooth:
Group 1: Non-restored teeth
Group 2: Prosthetically restored teeth
Clinical periodontal indices will be assessed at baseline and postoperatively. Oral health-related quality of life will be evaluated using the OHIP-14 questionnaire administered at baseline, one day, one week, and one month following surgery. Patient-reported outcomes will include a satisfaction questionnaire at one month and a visual analog scale (VAS) for postoperative pain during the first week. The number of analgesics consumed will also be recorded.
The primary objective is to compare changes in OHIP-14 scores between groups over time. Secondary outcomes include postoperative pain, patient satisfaction, and the association of clinical and surgical parameters with quality of life measures.
Data will be analyzed using descriptive and inferential statistics. Normality of distribution will be tested, and comparisons between repeated measures and groups will be conducted with appropriate parametric or non-parametric tests. Correlation analyses will be performed to examine relationships between clinical, surgical, and patient-reported variables. The calculated sample size is 49 participants, accounting for potential dropouts.
- Conditions
- Free Gingival Graft, Patient Satisfaction
- Being tested
- Free Gingival Graft
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free Gingival GraftProcedure or surgery
All patients will undergo free gingival graft surgery by the same surgeon using the same surgical protocol.
| Study group | Role | What they receive |
|---|---|---|
| Prosthetically restored teeth | Experimental | Prosthetically restored teeth will also be included in this group. Free gingival graft surgery will be performed Receives: Procedure: Free Gingival Graft |
| Non-restored teeth | Experimental | Non-restored teeth will also be included in this group. Free gingival graft surgery will be performed Receives: Procedure: Free Gingival Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral health impact profile- 14 Scale
Oral health impact profile- 14 Scale OHIP-14 questionnaire: OHIP-14 consists of 14 questions and Likert scale is used (0=Never, 1=Rarely, 2=Sometimes, 3=Frequently and 4=Always). In the evaluation of OHIP-14, scoring is done separately in 7 categories under the main titles of functional limitation, physical pain, psychological discomfort, physical disability, psychological disability and handicap and the total score obtained by the sum of all these category scores
Measured: Before FGG surgery and After 1 day, 1 week, and 1 month
Satisfaction questionnaire
The satisfaction survey consists of 13 questions and is answered as yes or no. The patient's level of satisfaction with the treatment will be assessed with a 13-question survey asked 1 month after the Free Gingival Graft treatment.
Measured: 1 month after the sugery
Secondary outcomes (4)
VAS pain scale
VAS VISUAL ANALOG SCALE (VAS) PAIN SCALE: The post-operative pain levels of the patients will be evaluated with the VAS pain scale. The pain felt will be marked on the VAS pain scale. On the horizontal scale, 0 means no pain, and 100 means unbearable pain.
Measured: 1 week during after the surgery
Number of painkillers used
Number of painkillers used
Measured: 1 week during after the surgery
Clinical periodontal index
Clinical periodontal measurements are given below. Plaque index Gingival index Bleeding index on probing Pocket depth Clinical attachment level Keratinized gingival width
Measured: Before FGG surgery and 1 month after the sugery
Operational data
Graft width (mm) Graft length (mm) Graft thickness(mm) Graft volume (Graft width x Graft length x Graft thickness ) Recipient bed location (maxilla-mandible, anterior-posterior)
Measured: On the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start21 Oct 2024
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Free Gingival GraftStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- parallel clinical prospective study
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Gelisim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serap Karakış Akcan, Istanbul Gelisim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167901
- Sponsor's protocol ID
- 2024-16-79
- Status last verified
- Sep 2025
- First submitted
- 9 Jul 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It can be shared if the responsible researcher is contacted.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Free Gingival Grafts on Patient Satisfaction
- ClinicalTrials.gov ID
- NCT07167901
- Acronym / sponsor ID
- 2024-16-79
- Conditions
- Free Gingival Graft, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Istanbul Gelisim UniversityUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares the effects of free gingival graft (FGG) surgery on prosthetically restored and non-restored teeth regarding patients' oral quality of life using various scales. Patients with insufficient attached gingiva who are indicated for free gingival graft surgery will be included in this study. We will collect demographic data, including age, gender for all patients who meet the inclusion criteria. Prior to the surgery, all patients will have their oral periodontal indices and their scores on the Oral Health Impact Profile-14 (OHIP-14) recorded. All patients will undergo free gingival graft surgery using the same surgical technique, and we will record operation details such as graft dimensions and the location of the recipient bed. The OHIP-14 will be completed three times: once one day, one week, and again one month after the surgery. Additionally, a satisfaction questionnaire will be administered one month post-operation, and a visual analog scale (VAS) for pain will be collected during one week after the surgery. Following statistical analysis of the collected data, we will report on the impact of the free gingival graft surgery on oral health-related quality of life. The distribution of OHIP-14 scores, satisfaction survey results, and VAS pain scale data will be analyzed in relation to demographic characteristics and their association with surgical data.
Detailed description
This clinical study is designed to evaluate the impact of free gingival graft (FGG) surgery on oral health-related quality of life in patients with insufficient attached gingiva. Participants will be recruited from the Departments of Periodontology at Istanbul Gelişim University and Kütahya Health Sciences University.
All participants will receive phase I periodontal treatment and oral hygiene instructions prior to surgery. After a four-week healing period, FGG surgery will be performed using a standardized surgical technique. Surgical data, including graft dimensions and recipient site location, will be recorded during the procedure.
Participants will be categorized into two groups based on the presence or absence of prosthetic restoration on the treated tooth:
Group 1: Non-restored teeth
Group 2: Prosthetically restored teeth
Clinical periodontal indices will be assessed at baseline and postoperatively. Oral health-related quality of life will be evaluated using the OHIP-14 questionnaire administered at baseline, one day, one week, and one month following surgery. Patient-reported outcomes will include a satisfaction questionnaire at one month and a visual analog scale (VAS) for postoperative pain during the first week. The number of analgesics consumed will also be recorded.
The primary objective is to compare changes in OHIP-14 scores between groups over time. Secondary outcomes include postoperative pain, patient satisfaction, and the association of clinical and surgical parameters with quality of life measures.
Data will be analyzed using descriptive and inferential statistics. Normality of distribution will be tested, and comparisons between repeated measures and groups will be conducted with appropriate parametric or non-parametric tests. Correlation analyses will be performed to examine relationships between clinical, surgical, and patient-reported variables. The calculated sample size is 49 participants, accounting for potential dropouts.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- parallel clinical prospective study
| Arm | Type | Receives |
|---|---|---|
| Prosthetically restored teeth | Experimental | Procedure: Free Gingival GraftProsthetically restored teeth will also be included in this group. Free gingival graft surgery will be performed |
| Non-restored teeth | Experimental | Procedure: Free Gingival GraftNon-restored teeth will also be included in this group. Free gingival graft surgery will be performed |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being between the ages of 18-65
- The patient does not have any systemic disease
- The patient is cooperative
- Patients with keratinized mucosa deficiency or insufficiency (less than 1 mm)
Key exclusion criteria (6 listed)
- regnant and breastfeeding patients
- Mentally retarded patients
- Patients who smoke more than 10 cigarettes per day
- Patients with bleeding disorders or anticoagulant medication use
- Patients who use medications that suppress the immune system or impair healing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Free Gingival GraftAll patients will undergo free gingival graft surgery by the same surgeon using the same surgical protocol. | Procedure or surgery | Non-restored teeth, Prosthetically restored teeth |
Primary outcome
Oral health impact profile- 14 Scale
Time frame: Before FGG surgery and After 1 day, 1 week, and 1 month
Oral health impact profile- 14 Scale OHIP-14 questionnaire: OHIP-14 consists of 14 questions and Likert scale is used (0=Never, 1=Rarely, 2=Sometimes, 3=Frequently and 4=Always). In the evaluation of OHIP-14, scoring is done separately in 7 categories under the main titles of functional limitation, physical pain, psychological discomfort, physical disability, psychological disability and handicap and the total score obtained by the sum of all these category scores
Satisfaction questionnaire
Time frame: 1 month after the sugery
The satisfaction survey consists of 13 questions and is answered as yes or no. The patient's level of satisfaction with the treatment will be assessed with a 13-question survey asked 1 month after the Free Gingival Graft treatment.
4 secondary outcomes
VAS pain scale
Time frame: 1 week during after the surgery
Number of painkillers used
Time frame: 1 week during after the surgery
Clinical periodontal index
Time frame: Before FGG surgery and 1 month after the sugery
Operational data
Time frame: On the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: No. It can be shared if the responsible researcher is contacted.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free Gingival Graft in people with Free Gingival Graft and Patient Satisfaction, 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 4 inclusion and 6 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 11 Sep 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?
Oral health impact profile- 14 Scale (time frame: Before FGG surgery and After 1 day, 1 week, and 1 month). 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?
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 11 Sep 2025.