Free Gingival Graft Volume Change(DIMENSIONAL)NCT06250179
3D VOLUMETRIC CHANGE OF THE PALATAL DONOR REGION IN WOUND HEALING
A study testing free gingiva graft surgery in people with Free Gingival Graft Volume Change, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this clinical trial is planned to be conducted with 45 individuals aged between 18-65, with Cairo type I gingival recession and patients requiring free gingival surgery. It was aimed to investigate when the palatal mucosa will return to its previous volume in the donor area and the effect of smoking. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Free Gingival Graft Volume Change
- What is being tested?
- free gingiva graft surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2024to 1 Dec 2024
- 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
- Volunteers aged 18 and over
- Treatments with Cairo type I gingival treatment and requiring free gingival surgery
- There is no psychiatric, mental or physical disability
- My son has not received periodontal treatment within 6 months.
- Being systemically healthy
- Having at least 20 teeth in your entire mouth
Show all 10Show fewer
- Getting diagnosed with healthy gums
- Not using any medication
- Not pregnant
- Not having used any antibiotics, anti-inflammatory or any other medication that will swell the periodontal tissues in the last 6 months for any reason.
Who cannot join
- 1) Being outside the inclusion criteria and not agreeing to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this clinical trial is planned to be conducted with 45 individuals aged between 18-65, with Cairo type I gingival recession and patients requiring free gingival surgery. It was aimed to investigate when the palatal mucosa will return to its previous volume in the donor area and the effect of smoking. The main questions it aims to answer are:
- Evaluation of 3D volume change of the palatal donor area from which free gingival graft was taken
- determining how long it takes for the palatal mucosa to regain its original shape and thickness Participants will be asked to comply with postoperative recommendations and pay attention to oral hygiene.
Read more
If there is a comparison group: Researchers use it to see if smoking affects the volume change in the donor area.
They will compare non-smokers with clinically healthy gums, 'light' smokers who report smoking less than 5 cigarettes per day and patients with clinically healthy gums, and ex-smokers with clinically healthy gums who have not smoked for 5 years.
Read the detailed description
This study is planned to be conducted with 45 individuals aged between 18-65 who applied to Necmettin Erbakan University Faculty of Dentistry Department of Periodontology for various reasons. In the Department of Periodontology, each patient diagnosed with periodontal disease after clinical and radiological evaluation is initially treated with phase-1 treatment. In addition, the treatment of patients with mucogingival problems (gingival recession, keratinized gingival insufficiency, shallow vestibule depth) whose phase-1 treatment has been completed in our periodontology clinic continues (with free gingival graft and connective tissue graft surgery, etc.). Pre- and post-operative clinical measurements and photographs of patients for whom surgical procedures are planned are taken and kept in our archive.
In this prospectively planned study, the palatal area of patients who have received an indication for free gingival surgery for any reason and who meet the inclusion criteria and have agreed to participate in the study will be scanned with an intraoral scanner before and after the procedure, and the changes in palate volume will be monitored at 1st and 3rd month follow-ups.
Inclusion and exclusion criteria (limitations):
Study inclusion criteria:
- Volunteers aged 18 and over
- Patients with Cairo type I gingival recession and requiring free gingival surgery
- Not having a psychiatric, mental or physical disability
- Not having received periodontal treatment in the last 6 months
- Being systemically healthy
- Having at least 20 teeth in your entire mouth
- Getting diagnosed with healthy gums
- Not using any medication
- Not being pregnant
- Not having used any antibiotics, anti-inflammatory or any other drugs that may affect periodontal tissues in the last 6 months for any reason.
Exclusion criteria from the study:
- Being outside the inclusion criteria and not agreeing to participate in the study individual selection If the patients who come to the Periodontology Clinic Secretariat for periodontal treatment meet the inclusion criteria of the study whose Phase-1 treatment has been completed, the patients who accept the study and those who sign the consent form will be included in the study.
Considering the possibility of participants dropping out of the study, the number of individuals to be included in each group was determined as 15 and it is planned to be conducted with 45 individuals in total.
Group 1: Patients who are non-smokers and have clinically healthy gums Group 2: 'Light' smokers who report smoking less than 5 cigarettes per day and patients with clinically healthy gums Group 3: Patients with clinically healthy gums and ex-smokers who have not smoked for 5 years.
An intraoral optical scanner (TRIOS, 3Shape) will be used to obtain digital models as STL files at baseline (before surgery) and at 1 and 3 months. STL files will be imported into a digital imaging software (Geomagic Control X®) to measure donor site volume changes over time. All digital volumetric analyzes will be performed. STL files from baseline and follow-up visits will be overlaid and matched using the most appropriate algorithm. Stable anatomical landmarks (teeth and contralateral palate) will be used to perform overlay of models to guarantee maximum accuracy of digital analysis. Observed volumetric results are planned to include: average volumetric (Volume) changes, average distance between surfaces (difference in average thickness of the reconstructed volume; DD), and linear dimensional changes (LD) at points 3, 5, and 7 mm. Patient age, gender, and graft dimensions (width, height, and thickness) will also be recorded. The primary outcome of this study is to observe the post-operative dimensional changes of donor areas at different follow-up periods by evaluating them in volumetric and linear dimensions. The secondary outcome is to evaluate volumetric outcomes (such as gender, age, and graft size) together with patient (including smoking) and surgery-related factors that may affect the outcome.
- Conditions
- Free Gingival Graft Volume Change
- Being tested
- free gingiva graft surgery
- Keywords
- free gingival graft, cigarette, 3D scanning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
free gingiva graft surgeryProcedure or surgery
For insufficient gingival height in patients, the free gingival graft taken from the palate will be sutured to the relevant area.
| Study group | Role | What they receive |
|---|---|---|
| Non-smoking patients | Experimental | The patient will receive a free gingival graft for insufficient keratinized gingival height. Receives: Procedure: free gingiva graft surgery |
| 'Light' smokers who report smoking less than 5 cigarettes per day | Active comparator | The patient will receive a free gingival graft for insufficient keratinized gingival height. Receives: Procedure: free gingiva graft surgery |
| Non-smoker for 5 years, quit smoking patients | Active comparator | The patient will receive a free gingival graft for insufficient keratinized gingival height. Receives: Procedure: free gingiva graft surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examination of volume change in the palatal donor region in smoking and non-smoking patients
It was aimed to examine the volume change among the 3 groups in our study by looking at its connection with smoking. A study plan was created by comparing the 3D shape device on which the scans were made with Geomatic Control X and looking at the volume change.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start10 Jul 2024
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Free Gingival Graft Volume ChangeStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Collaborators
- DİLEK ÖZKAN ŞEN
- Responsible party
- Principal investigator, FATMA SARAÇ, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250179
- Sponsor's protocol ID
- necmettinerbakanü
- Acronym
- (DIMENSIONAL)
- Status last verified
- Jul 2024
- First submitted
- 1 Feb 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Free gingiva in non-smoking patients with insufficient keratinized gingival height and clinically healthy gingiva, 'light' smokers who report smoking less than 5 cigarettes per day and patients with clinically healthy gingiva, and patients with healthy gingiva who have quit smoking and have not smoked for 5 years. It was aimed to evaluate the 3D volume change of the grafted palatal donor area, to determine the volumetric change in the donor area and how long it took for the palatal mucosa to regain its original shape and thickness.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D VOLUMETRIC CHANGE OF THE PALATAL DONOR REGION IN WOUND HEALING
- ClinicalTrials.gov ID
- NCT06250179
- Acronym / sponsor ID
- (DIMENSIONAL) / necmettinerbakanü
- Conditions
- Free Gingival Graft Volume Change
- Keywords
- free gingival graft, cigarette, 3D scanning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Collaborators
- DİLEK ÖZKAN ŞEN
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 8 Feb 2024 (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.
The purpose of this clinical trial is planned to be conducted with 45 individuals aged between 18-65, with Cairo type I gingival recession and patients requiring free gingival surgery. It was aimed to investigate when the palatal mucosa will return to its previous volume in the donor area and the effect of smoking. The main questions it aims to answer are:
- Evaluation of 3D volume change of the palatal donor area from which free gingival graft was taken
- determining how long it takes for the palatal mucosa to regain its original shape and thickness Participants will be asked to comply with postoperative recommendations and pay attention to oral hygiene.
If there is a comparison group: Researchers use it to see if smoking affects the volume change in the donor area.
They will compare non-smokers with clinically healthy gums, 'light' smokers who report smoking less than 5 cigarettes per day and patients with clinically healthy gums, and ex-smokers with clinically healthy gums who have not smoked for 5 years.
Detailed description
This study is planned to be conducted with 45 individuals aged between 18-65 who applied to Necmettin Erbakan University Faculty of Dentistry Department of Periodontology for various reasons. In the Department of Periodontology, each patient diagnosed with periodontal disease after clinical and radiological evaluation is initially treated with phase-1 treatment. In addition, the treatment of patients with mucogingival problems (gingival recession, keratinized gingival insufficiency, shallow vestibule depth) whose phase-1 treatment has been completed in our periodontology clinic continues (with free gingival graft and connective tissue graft surgery, etc.). Pre- and post-operative clinical measurements and photographs of patients for whom surgical procedures are planned are taken and kept in our archive.
In this prospectively planned study, the palatal area of patients who have received an indication for free gingival surgery for any reason and who meet the inclusion criteria and have agreed to participate in the study will be scanned with an intraoral scanner before and after the procedure, and the changes in palate volume will be monitored at 1st and 3rd month follow-ups.
Inclusion and exclusion criteria (limitations):
Study inclusion criteria:
- Volunteers aged 18 and over
- Patients with Cairo type I gingival recession and requiring free gingival surgery
- Not having a psychiatric, mental or physical disability
- Not having received periodontal treatment in the last 6 months
- Being systemically healthy
- Having at least 20 teeth in your entire mouth
- Getting diagnosed with healthy gums
- Not using any medication
- Not being pregnant
- Not having used any antibiotics, anti-inflammatory or any other drugs that may affect periodontal tissues in the last 6 months for any reason.
Exclusion criteria from the study:
- Being outside the inclusion criteria and not agreeing to participate in the study individual selection If the patients who come to the Periodontology Clinic Secretariat for periodontal treatment meet the inclusion criteria of the study whose Phase-1 treatment has been completed, the patients who accept the study and those who sign the consent form will be included in the study.
Considering the possibility of participants dropping out of the study, the number of individuals to be included in each group was determined as 15 and it is planned to be conducted with 45 individuals in total.
Group 1: Patients who are non-smokers and have clinically healthy gums Group 2: 'Light' smokers who report smoking less than 5 cigarettes per day and patients with clinically healthy gums Group 3: Patients with clinically healthy gums and ex-smokers who have not smoked for 5 years.
An intraoral optical scanner (TRIOS, 3Shape) will be used to obtain digital models as STL files at baseline (before surgery) and at 1 and 3 months. STL files will be imported into a digital imaging software (Geomagic Control X®) to measure donor site volume changes over time. All digital volumetric analyzes will be performed. STL files from baseline and follow-up visits will be overlaid and matched using the most appropriate algorithm. Stable anatomical landmarks (teeth and contralateral palate) will be used to perform overlay of models to guarantee maximum accuracy of digital analysis. Observed volumetric results are planned to include: average volumetric (Volume) changes, average distance between surfaces (difference in average thickness of the reconstructed volume; DD), and linear dimensional changes (LD) at points 3, 5, and 7 mm. Patient age, gender, and graft dimensions (width, height, and thickness) will also be recorded. The primary outcome of this study is to observe the post-operative dimensional changes of donor areas at different follow-up periods by evaluating them in volumetric and linear dimensions. The secondary outcome is to evaluate volumetric outcomes (such as gender, age, and graft size) together with patient (including smoking) and surgery-related factors that may affect the outcome.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-smoking patients | Experimental | Procedure: free gingiva graft surgeryThe patient will receive a free gingival graft for insufficient keratinized gingival height. |
| 'Light' smokers who report smoking less than 5 cigarettes per day | Active comparator | Procedure: free gingiva graft surgeryThe patient will receive a free gingival graft for insufficient keratinized gingival height. |
| Non-smoker for 5 years, quit smoking patients | Active comparator | Procedure: free gingiva graft surgeryThe patient will receive a free gingival graft for insufficient keratinized gingival height. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Volunteers aged 18 and over
- Treatments with Cairo type I gingival treatment and requiring free gingival surgery
- There is no psychiatric, mental or physical disability
- My son has not received periodontal treatment within 6 months.
- Being systemically healthy
Key exclusion criteria (1 listed)
- 1) Being outside the inclusion criteria and not agreeing to participate in the study
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 gingiva graft surgeryFor insufficient gingival height in patients, the free gingival graft taken from the palate will be sutured to the relevant area. | Procedure or surgery | 'Light' smokers who report smoking less than 5 cigarettes per day, Non-smoker for 5 years, quit smoking patients, Non-smoking patients |
Primary outcome
Examination of volume change in the palatal donor region in smoking and non-smoking patients
Time frame: 3 months
It was aimed to examine the volume change among the 3 groups in our study by looking at its connection with smoking. A study plan was created by comparing the 3D shape device on which the scans were made with Geomatic Control X and looking at the volume change.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Individual participant dataSharing planned: Yes. Free gingiva in non-smoking patients with insufficient keratinized gingival height and clinically healthy gingiva, 'light' smokers who report smoking less than 5 cigarettes per day and patients with clinically healthy gingiva, and patients with healthy gingiva who have quit smoking and have not smoked for 5 years. It was aimed to evaluate the 3D volume change of the grafted palatal donor area, to determine the volumetric change in the donor area and how long it took for the palatal mucosa to regain its original shape and thickness.
Related trials for Free Gingival Graft Volume Change
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3D Digital Assessment of Soft Tissue Changes After Modified FGG
Gingival Recession, Localized, Soft Tissue Volume Changes
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 gingiva graft surgery in people with Free Gingival Graft Volume Change, run by Necmettin Erbakan 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 10 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 Jul 2024. 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?
Results are not available in the source record.
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?
Examination of volume change in the palatal donor region in smoking and non-smoking patients (time frame: 3 months). 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 25 Jul 2024.