Insufficient Keratinized GingivaNCT06399198
Three-dimensional Changes in Free Gingival Grafts Around Dental Implants
A study testing Free gingival graft in people with Insufficient Keratinized Gingiva, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to evaluate the stability of the free gingival graft dimensions around dental implants and to compare three-dimensional changes according to smoking status. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insufficient Keratinized Gingiva
- 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
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Nov 2024to 10 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Periodontal and peri-implant tissue health
- Good oral hygiene (plaque accumulation <20%)
- Either around the functioning implant or in patients scheduled for second-stage surgery following implant surgery <2 mm keratinized gingiva on the vestibular side of the implant
- No systemic disease and medication use that may affect soft tissue healing.
- Volunteering to participate in the study
Who cannot join
- Systemic disease that is a contraindication to the surgical procedure,
- Uncontrolled diabetes (HbA1c > 7),
- Being pregnant or breastfeeding,
- Autoimmune and/or inflammatory diseases of the oral cavity,
- Active periodontal disease,
- Incorrectly positioned implants
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Biruni University
Istanbul
Ayşe Ege SELMAN
About this study
Official title: Evaluation of the Three-dimensional Changes in Free Gingival Grafts Around Dental Implants
The purpose of this study is to evaluate the stability of the free gingival graft dimensions around dental implants and to compare three-dimensional changes according to smoking status. Its primary goal is to provide an answer to:
Is this grafting procedure stable around dental implants? Are there any differences in tissue stability between smoker and non-smoker patients?
Read more
Our study consists of 2 groups:
The first group includes smoker patients who need free gingival grafts around their dental implants (n=16).
The second group includes non-smoker patients who need free gingival grafts around their dental implants (n=16).
Clinical measurements will be recorded at the baseline, 1st month, 3rd month, and 6th month of the study. An intraoral digital scanner will be used to measure the dimension changes of the graft at the baseline, after the surgery, 1st month, 3rd month, and 6th month of the study. Wound healing will be evaluated on postoperative days 10, 1 month, 3 months, and 6 months. Visual Analog Scale will be used to measure postoperative pain, and the number of painkillers taken will be recorded.
- Conditions
- Insufficient Keratinized Gingiva
- Being tested
- Free gingival graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free gingival graftProcedure or surgery
After adequate local anesthesia is achieved, a horizontal incision will be placed at mucogingival junction level to prepare the recipient bed. A split-thickness flap will be raised without disturbing the periosteum. A free gingival graft will be obtained from the palate. The graft will be shaped and sutured to the recipient surface.
| Study group | Role | What they receive |
|---|---|---|
| smoker | Experimental | Not described Receives: Procedure: Free gingival graft |
| non-smoker | Experimental | Not described Receives: Procedure: Free gingival graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
The three-dimensional changes of free gingival graft
An intraoral digital scanner will be used to assess the graft's dimensions alterations.
Measured: Baseline
The three-dimensional changes of free gingival graft.
An intraoral digital scanner will be used to assess the graft's dimensions alterations.
Measured: 1st month
The three-dimensional changes of free gingival graft
An intraoral digital scanner will be used to assess the graft's dimensions alterations.
Measured: 3rd month
The three-dimensional changes of free gingival graft
An intraoral digital scanner will be used to assess the graft's dimensions alterations.
Measured: 6th month
Secondary outcomes (25)
Plaque index
0: Absence of microbial plaque
Thin plaque layer at the mucosal margin, only detectable by scraping with a probe Moderate layer of plaque in the along the mucosal margin; interdental spaces free, but plaque is visible to naked eye Abundant plaque along with the mucosal margin; interdental places filled with plaque
Measured: Baseline
Plaque index
0: Absence of microbial plaque
Thin plaque layer at the mucosal margin, only detectable by scraping with a probe Moderate layer of plaque in the along the mucosal margin; interdental spaces free, but plaque is visible to naked eye Abundant plaque along with the mucosal margin; interdental places filled with plaque
Measured: 1st month
Plaque index
0: Absence of microbial plaque
Thin plaque layer at the mucosal margin, only detectable by scraping with a probe Moderate layer of plaque in the along the mucosal margin; interdental spaces free, but plaque is visible to naked eye Abundant plaque along with the mucosal margin; interdental places filled with plaque
Measured: 3rd month
Plaque index
0: Absence of microbial plaque
Thin plaque layer at the mucosal margin, only detectable by scraping with a probe Moderate layer of plaque in the along the mucosal margin; interdental spaces free, but plaque is visible to naked eye Abundant plaque along with the mucosal margin; interdental places filled with plaque
Measured: 6th month
Gingival Index
0: normal gingiva
mild inflammation - slight change in color and slight edema but no bleeding on probing moderate inflammation - redness, edema and glazing, bleeding on probing severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding
Measured: Baseline (prior to therapy)
Gingival Index
0: normal gingiva
mild inflammation - slight change in color and slight edema but no bleeding on probing moderate inflammation - redness, edema and glazing, bleeding on probing severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding
Measured: 1st month
Gingival Index
0: normal gingiva
mild inflammation - slight change in color and slight edema but no bleeding on probing moderate inflammation - redness, edema and glazing, bleeding on probing severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding
Measured: 3rd month
Gingival Index
0: normal gingiva
mild inflammation - slight change in color and slight edema but no bleeding on probing moderate inflammation - redness, edema and glazing, bleeding on probing severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding
Measured: 6th month
Bleeding on probing
Bleeding on probing A bleeding-on-probing percentage score assessed as the proportion of bleeding sites (dichotomous yes/no evaluation) when stimulated by a standardized manual probe with a controlled (~25 g) force to the bottom of the sulcus/pocket at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) on all present teeth/ implants.
Measured: Baseline
Bleeding on probing
Bleeding on probing A bleeding-on-probing percentage score assessed as the proportion of bleeding sites (dichotomous yes/no evaluation) when stimulated by a standardized manual probe with a controlled (~25 g) force to the bottom of the sulcus/pocket at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) on all present teeth/ implants.
Measured: 1st month
Bleeding on probing
Bleeding on probing A bleeding-on-probing percentage score assessed as the proportion of bleeding sites (dichotomous yes/no evaluation) when stimulated by a standardized manual probe with a controlled (~25 g) force to the bottom of the sulcus/pocket at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) on all present teeth/ implants.
Measured: 3rd month
Bleeding on probing
Bleeding on probing A bleeding-on-probing percentage score assessed as the proportion of bleeding sites (dichotomous yes/no evaluation) when stimulated by a standardized manual probe with a controlled (~25 g) force to the bottom of the sulcus/pocket at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) on all present teeth/ implants.
Measured: 6th month
Keratinized mucosa width
The apical-coronal distance from the mucosal margin to the mucogingival junction (MGJ) Measurements will be made at three points on implants (mesiobuccal, midbuccal, distobuccal) using a periodontal probe.
Measured: Baseline (prior to therapy)
Keratinized mucosa width
The apical-coronal distance from the mucosal margin to the mucogingival junction (MGJ) Measurements will be made at three points on implants (mesiobuccal, midbuccal, distobuccal) using a periodontal probe.
Measured: 1st month
Keratinized mucosa width
The apical-coronal distance from the mucosal margin to the mucogingival junction (MGJ) Measurements will be made at three points on implants (mesiobuccal, midbuccal, distobuccal) using a periodontal probe.
Measured: 3rd month
Keratinized mucosa width
The apical-coronal distance from the mucosal margin to the mucogingival junction (MGJ) Measurements will be made at three points on implants (mesiobuccal, midbuccal, distobuccal) using a periodontal probe.
Measured: 6th month
Probing depth
Probing pocket depth: The distance from the base of the pocket to the mucosal margin. Measurements will be made at six points on all teeth/ implants (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) using a periodontal probe.
Measured: Baseline
Probing depth
Probing pocket depth: The distance from the base of the pocket to the mucosal margin. Measurements will be made at six points on all teeth/ implants (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) using a periodontal probe.
Measured: 1st month
Probing depth
Probing pocket depth: The distance from the base of the pocket to the mucosal margin. Measurements will be made at six points on all teeth/ implants (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) using a periodontal probe.
Measured: 3rd month
Probing depth
Probing pocket depth: The distance from the base of the pocket to the mucosal margin. Measurements will be made at six points on all teeth/ implants (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) using a periodontal probe.
Measured: 6th month
Wound healing
Presence of infection (yes/no), soft tissue dehiscence (yes/no), and graft failure (yes/no) will be recorded.
Measured: 10th day
Wound healing
Presence of infection (yes/no), soft tissue dehiscence (yes/no), and graft failure (yes/no) will be recorded.
Measured: 1st month
Wound healing
Presence of infection (yes/no), soft tissue dehiscence (yes/no), and graft failure (yes/no) will be recorded.
Measured: 3rd month
Wound healing
Presence of infection (yes/no), soft tissue dehiscence (yes/no), and graft failure (yes/no) will be recorded.
Measured: 6th month
Patient reported outcomes
After the surgical procedure, patients will be asked to complete a form consisting of 4 items: (1) assessment of the intensity of postoperative pain/discomfort (by Visual Analog Scale), (2) duration of pain (in days), (3) number of analgesic tablets taken, and (4) willingness to undergo the same surgery again (yes/no).
Measured: 10th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start10 Nov 2024
- Primary completion10 Jul 2025 (estimated)
- Study completion10 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insufficient Keratinized GingivaStudies of the same condition, open and under way.
- More trials run by Biruni 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Ege SELMAN, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399198
- Sponsor's protocol ID
- free gingival graft dimention
- Status last verified
- Nov 2024
- First submitted
- 1 May 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Three-dimensional Changes in Free Gingival Grafts Around Dental Implants
- ClinicalTrials.gov ID
- NCT06399198
- Acronym / sponsor ID
- free gingival graft dimention
- Conditions
- Insufficient Keratinized Gingiva
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 10 Nov 2024 (actual)
- Primary completion
- 10 Jul 2025 (estimated)
- Study completion
- 10 Jul 2025 (estimated)
- First posted
- 3 May 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 study is to evaluate the stability of the free gingival graft dimensions around dental implants and to compare three-dimensional changes according to smoking status. Its primary goal is to provide an answer to:
Is this grafting procedure stable around dental implants? Are there any differences in tissue stability between smoker and non-smoker patients?
Our study consists of 2 groups:
The first group includes smoker patients who need free gingival grafts around their dental implants (n=16).
The second group includes non-smoker patients who need free gingival grafts around their dental implants (n=16).
Clinical measurements will be recorded at the baseline, 1st month, 3rd month, and 6th month of the study. An intraoral digital scanner will be used to measure the dimension changes of the graft at the baseline, after the surgery, 1st month, 3rd month, and 6th month of the study. Wound healing will be evaluated on postoperative days 10, 1 month, 3 months, and 6 months. Visual Analog Scale will be used to measure postoperative pain, and the number of painkillers taken will be recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| smoker | Experimental | Procedure: Free gingival graft |
| non-smoker | Experimental | Procedure: Free gingival graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Periodontal and peri-implant tissue health
- Good oral hygiene (plaque accumulation <20%)
- Either around the functioning implant or in patients scheduled for second-stage surgery following implant surgery <2 mm keratinized gingiva on the vestibular side of the implant
- No systemic disease and medication use that may affect soft tissue healing.
- Volunteering to participate in the study
Key exclusion criteria (6 listed)
- Systemic disease that is a contraindication to the surgical procedure,
- Uncontrolled diabetes (HbA1c > 7),
- Being pregnant or breastfeeding,
- Autoimmune and/or inflammatory diseases of the oral cavity,
- Active periodontal disease,
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 graftAfter adequate local anesthesia is achieved, a horizontal incision will be placed at mucogingival junction level to prepare the recipient bed. A split-thickness flap will be raised without disturbing the periosteum. A free gingival graft will be obtained from the palate. The graft will be shaped and sutured to the recipient surface. | Procedure or surgery | non-smoker, smoker |
Primary outcome
The three-dimensional changes of free gingival graft
Time frame: Baseline
An intraoral digital scanner will be used to assess the graft's dimensions alterations.
The three-dimensional changes of free gingival graft.
Time frame: 1st month
An intraoral digital scanner will be used to assess the graft's dimensions alterations.
The three-dimensional changes of free gingival graft
Time frame: 3rd month
An intraoral digital scanner will be used to assess the graft's dimensions alterations.
The three-dimensional changes of free gingival graft
Time frame: 6th month
An intraoral digital scanner will be used to assess the graft's dimensions alterations.
25 secondary outcomes
Plaque index
Time frame: Baseline
Plaque index
Time frame: 1st month
Plaque index
Time frame: 3rd month
Plaque index
Time frame: 6th month
Gingival Index
Time frame: Baseline (prior to therapy)
Gingival Index
Time frame: 1st month
Gingival Index
Time frame: 3rd month
Gingival Index
Time frame: 6th month
Bleeding on probing
Time frame: Baseline
Bleeding on probing
Time frame: 1st month
Bleeding on probing
Time frame: 3rd month
Bleeding on probing
Time frame: 6th month
Keratinized mucosa width
Time frame: Baseline (prior to therapy)
Keratinized mucosa width
Time frame: 1st month
Keratinized mucosa width
Time frame: 3rd month
Keratinized mucosa width
Time frame: 6th month
Probing depth
Time frame: Baseline
Probing depth
Time frame: 1st month
Probing depth
Time frame: 3rd month
Probing depth
Time frame: 6th month
Wound healing
Time frame: 10th day
Wound healing
Time frame: 1st month
Wound healing
Time frame: 3rd month
Wound healing
Time frame: 6th month
Patient reported outcomes
Time frame: 10th day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
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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.
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 Insufficient Keratinized Gingiva, run by Biruni 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 5 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: looking for participants now, as of the sponsor's last update on 27 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayse E Selman (+905366393184, aselman@biruni.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The three-dimensional changes of free gingival graft (time frame: Baseline). The study lists 4 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 27 Nov 2024.