Insufficient Keratinized GingivaNCT07617987
Reharvested Free Gingival Grafts: 3D Shrinkage and Histological Changes
An observational study of Insufficient Keratinized Gingiva, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to evaluate the dimensional stability of free gingival grafts (FGG) and to investigate the relationship between graft shrinkage (GS) and the histological and biochemical characteristics of grafts reharvested from the same palatal donor site. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insufficient Keratinized Gingiva
- What is being tested?
- Free gingival graft and Re-harvested free gingival graft
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2026to 15 Sep 2027
- Phase
- Observational
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Systemically healthy, non-smoking individuals aged 18-65 years with insufficient keratinized gingiva (<2 mm; Lang \& Löe, 1972) involving the bilateral mandibular canine and/or premolar regions will be included in the study.
Who may be able to join
- Individuals aged between 18 and 65 years,
- Absence of any systemic disease that may adversely affect periodontal health and wound healing,
- Non-smokers,
- Periodontally healthy individuals,
- Mean plaque index (PI) score <1 following non-surgical periodontal therapy (NSPT),
- No use of antibiotics or anti-inflammatory drugs within the last 3 months,
- Not being pregnant or breastfeeding,
- Willingness to participate in the study by signing the informed consent form.
Who cannot join
- Presence of any systemic disease contraindicating surgical procedures,
- Use of medications or supplements affecting bleeding or wound healing,
- Presence of uncontrolled diabetes mellitus (HbA1c >7),
- Pregnancy or breastfeeding,
- History of chemotherapy or radiotherapy within the last 6 months,
- History of antibiotic use within the last 3 months,
Show all 9Show fewer
- Palatal mucosal thickness <3 mm or presence of palatal torus,
- Presence of deep and narrow (U-shaped) or shallow palatal vaults interfering with palatal measurements,
- Non-compliance with treatment or follow-up protocols.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Three-Dimensional Assessment of Graft Shrinkage in Relation to Histological Alterations in Reharvested Free Gingival Grafts From the Same Palatal Donor Site
The purpose of this study is to evaluate the dimensional stability of free gingival grafts (FGG) and to investigate the relationship between graft shrinkage (GS) and the histological and biochemical characteristics of grafts reharvested from the same palatal donor site. The primary objective is to investigate the relationship between histological alterations in grafts reharvested from the same donor site and graft shrinkage at the recipient site.
This study is designed as a split-mouth study in which FGGs are applied to contralateral recipient sites within the same patient. Each participant will receive two grafts: an initial graft harvested from the palatal donor site and a second graft reharvested from the same donor site 63 days after the initial procedure.
Read more
Graft dimensional changes will be evaluated using three-dimensional digital measurements. Intraoral digital scans will be obtained at baseline, immediately after surgery, and at 1 and 3 months postoperatively. GS will be assessed through superimposition of digital models.
In addition, histological, histomorphometric, and immunohistochemical analyses will be performed on tissue samples obtained from the donor site to evaluate collagen characteristics and epithelial structure. Furthermore, protein expression levels of specific markers, including collagen type I, collagen type III, and alpha-smooth muscle actin (α-SMA), will be assessed. Early wound healing at the recipient site will be evaluated using the Landry healing index at postoperative days 7, 14, and 28. In addition, biological mediators, including transforming growth factor beta 1 (TGF-β1), vascular endothelial growth factor A (VEGF-A), and platelet-derived growth factor (PDGF), will be analyzed in wound exudate samples obtained from the recipient site to biochemically assess the early healing process.
- Conditions
- Insufficient Keratinized Gingiva
- Being tested
- Free gingival graft, Re-harvested free gingival graft
- Keywords
- 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
Following adequate local anesthesia, a horizontal incision will be made at the level of the mucogingival junction to prepare the recipient bed. A split-thickness flap will be elevated without disturbing the periosteum. A free gingival graft will be harvested from the palatal donor site during the initial surgical procedure. The harvested graft will then be transferred to the recipient site, shaped to the desired dimensions, and stabilized with sutures.
Re-harvested free gingival graftProcedure or surgery
Following adequate local anesthesia, a horizontal incision will be made at the level of the mucogingival junction to prepare the recipient bed. A split-thickness flap will be elevated without disturbing the periosteum. A free gingival graft will be reharvested from the same palatal donor site 63 days after the initial surgery. The harvested graft will then be transferred to the recipient site, shaped to the desired dimensions, and stabilized with sutures.
| Study group | Role | What they receive |
|---|---|---|
| First free gingival graft | Recipient sites treated with free gingival grafts harvested from the palatal donor site during the initial surgical procedure. Receives: Procedure: Free gingival graft | |
| Re-harvested free gingival graft | Recipient sites treated with free gingival grafts re-harvested from the same palatal donor site 63 days after the initial surgery. Receives: Procedure: Re-harvested 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: Postoperative baseline (immediately after surgery)
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
Histological alterations in free gingival grafts
Histomorphometric and immunohistochemical evaluation of epithelial thickness and Type I and Type III collagen ratios in free gingival graft samples obtained from the palatal donor site.
Measured: Baseline (initial graft harvesting procedure)
Histological alterations in re-harvested free gingival grafts
Histomorphometric and immunohistochemical evaluation of epithelial thickness and Type I and Type III collagen ratios in free gingival graft samples reharvested from the same palatal donor site.
Measured: 63 days after the initial surgery (re-harvesting procedure)
Secondary outcomes (16)
Keratinized mucosa width
The apical-coronal distance from the mucosal margin to the mucogingival junction (MGJ) Measurements will be made at three points on tooth (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 tooth (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 tooth (mesiobuccal, midbuccal, distobuccal) using a periodontal probe.
Measured: 3rd month
Gingival Recession Width
The widest horizontal distance between the mesial and distal gingival margins of the recession defect at the level of the cementoenamel junction (CEJ) will be measured using a periodontal probe held horizontally.
Measured: Baseline (prior to therapy)
Gingival Recession Width
The widest horizontal distance between the mesial and distal gingival margins of the recession defect at the level of the cementoenamel junction (CEJ) will be measured using a periodontal probe held horizontally.
Measured: 1st month
Gingival Recession Width
The widest horizontal distance between the mesial and distal gingival margins of the recession defect at the level of the cementoenamel junction (CEJ) will be measured using a periodontal probe held horizontally.
Measured: 3rd month
Gingival Thickness
Following local anesthesia, measurements will be performed at the distobuccal, midbuccal, and mesiobuccal aspects of the teeth in the recipient area by inserting a #20 spreader with a silicone stopper perpendicular to the gingival surface, 2 mm apical to the gingival margin. After hard tissue contact is achieved, the distance between the tip of the spreader and the silicone stopper will be measured using a digital caliper. The mean value of the measurements will be recorded.
Measured: Baseline
Gingival Thickness
Following local anesthesia, measurements will be performed at the distobuccal, midbuccal, and mesiobuccal aspects of the teeth in the recipient area by inserting a #20 spreader with a silicone stopper perpendicular to the gingival surface, 2 mm apical to the gingival margin. After hard tissue contact is achieved, the distance between the tip of the spreader and the silicone stopper will be measured using a digital caliper. The mean value of the measurements will be recorded.
Measured: 3rd month
Landry Healing Index
Healing at the recipient site will be evaluated according to tissue color, presence of bleeding and granulation tissue, suppuration, and epithelialization. Healing will be scored on a scale ranging from 1 to 5.
Measured: 7th day
Landry Healing Index
Healing at the recipient site will be evaluated according to tissue color, presence of bleeding and granulation tissue, suppuration, and epithelialization. Healing will be scored on a scale ranging from 1 to 5.
Measured: 14th day
Landry Healing Index
Healing at the recipient site will be evaluated according to tissue color, presence of bleeding and granulation tissue, suppuration, and epithelialization. Healing will be scored on a scale ranging from 1 to 5.
Measured: 28th day
Growth factor levels in wound fluid
Wound fluid samples will be collected from the mesiocoronal, distocoronal, mesioapical, and distoapical margins of the surgical recipient site using paper strips (Periopaper®, Oraflow, Plainview, NY, USA). The strips will be gently placed at the relevant sites for 30 seconds while avoiding mechanical trauma. VEGF-A, PDGF, and TGF-β1 levels will be evaluated.
Measured: 3rd day
Growth factor levels in wound fluid
Wound fluid samples will be collected from the mesiocoronal, distocoronal, mesioapical, and distoapical margins of the surgical recipient site using paper strips (Periopaper®, Oraflow, Plainview, NY, USA). The strips will be gently placed at the relevant sites for 30 seconds while avoiding mechanical trauma. VEGF-A, PDGF, and TGF-β1 levels will be evaluated.
Measured: 7th day
Protein expression levels in free gingival grafts,
Biochemical evaluation of type I collagen, type III collagen, and α-SMA protein expression levels in free gingival graft samples obtained from the donor site.
Measured: Baseline (initial graft harvesting procedure)
Protein expression levels in free gingival grafts
Biochemical evaluation of type I collagen, type III collagen, and α-SMA protein expression levels in free gingival graft samples obtained from the same donor site.
Measured: 63 days after the initial surgery (re-harvesting procedure)
Patient reported outcomes
After the surgical procedure, patients will be asked to complete a form consisting of 3 items: (1) assessment of the intensity of postoperative pain/discomfort (by Visual Analog Scale), (2) duration of pain (in days) and (3) number of analgesic tablets taken.
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 posted1 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Ege SELMAN, Biruni University
- Investigators
- Ayşe Ege Selman, Study chair, Biruni University, Faculty of Dentistry, Department of Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617987
- Sponsor's protocol ID
- 2024- BİAEK/17-32
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Keskiner I, Aydogdu A, Balli U, Kaleli AE. Quantitative changes in palatal donor site thickness after free gingival graft harvesting: a pilot study. J Clin Periodontol. 2016 Nov;43(11):976-984. doi: 10.1111/jcpe.12592. Epub 2016 Sep 9.
PubMed 27330024Hatipoglu H, Keceli HG, Guncu GN, Sengun D, Tozum TF. Vertical and horizontal dimensional evaluation of free gingival grafts in the anterior mandible: a case report series. Clin Oral Investig. 2007 Jun;11(2):107-13. doi: 10.1007/s00784-006-0084-x. Epub 2007 Feb 9.
PubMed 17294229Pippi R. Post-Surgical Clinical Monitoring of Soft Tissue Wound Healing in Periodontal and Implant Surgery. Int J Med Sci. 2017 Jul 18;14(8):721-728. doi: 10.7150/ijms.19727. eCollection 2017.
PubMed 28824306Guglielmoni P, Promsudthi A, Tatakis DN, Trombelli L. Intra- and inter-examiner reproducibility in keratinized tissue width assessment with 3 methods for mucogingival junction determination. J Periodontol. 2001 Feb;72(2):134-9. doi: 10.1902/jop.2001.72.2.134.
PubMed 11288784Zuhr O, Baumer D, Hurzeler M. The addition of soft tissue replacement grafts in plastic periodontal and implant surgery: critical elements in design and execution. J Clin Periodontol. 2014 Apr;41 Suppl 15:S123-42. doi: 10.1111/jcpe.12185.
PubMed 24640997Parvini P, Galarraga-Vinueza ME, Obreja K, Magini RS, Sader R, Schwarz F. Prospective study assessing three-dimensional changes of mucosal healing following soft tissue augmentation using free gingival grafts. J Periodontol. 2021 Mar;92(3):400-408. doi: 10.1002/JPER.19-0640. Epub 2020 Aug 21.
PubMed 33448379Tavelli L, Barootchi S, Stefanini M, Zucchelli G, Giannobile WV, Wang HL. Wound healing dynamics, morbidity, and complications of palatal soft-tissue harvesting. Periodontol 2000. 2023 Jun;92(1):90-119. doi: 10.1111/prd.12466. Epub 2022 Dec 30.
PubMed 36583690Gumus P, Buduneli E. Graft stabilization with cyanoacrylate decreases shrinkage of free gingival grafts. Aust Dent J. 2014 Mar;59(1):57-64. doi: 10.1111/adj.12149. Epub 2014 Feb 4.
PubMed 24494804Soileau KM, Brannon RB. A histologic evaluation of various stages of palatal healing following subepithelial connective tissue grafting procedures: a comparison of eight cases. J Periodontol. 2006 Jul;77(7):1267-73. doi: 10.1902/jop.2006.050129.
PubMed 16805692Silva CO, Ribeiro Edel P, Sallum AW, Tatakis DN. Free gingival grafts: graft shrinkage and donor-site healing in smokers and non-smokers. J Periodontol. 2010 May;81(5):692-701. doi: 10.1902/jop.2010.090381.
PubMed 20429648Lang NP, Loe H. The relationship between the width of keratinized gingiva and gingival health. J Periodontol. 1972 Oct;43(10):623-7. doi: 10.1902/jop.1972.43.10.623. No abstract available.
PubMed 4507712
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-Dimensional Assessment of Graft Shrinkage in Relation to Histological Alterations in Reharvested Free Gingival Grafts From the Same Palatal Donor Site
- ClinicalTrials.gov ID
- NCT07617987
- Acronym / sponsor ID
- 2024- BİAEK/17-32
- Conditions
- Insufficient Keratinized Gingiva
- Keywords
- free gingival graft
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 1 Jun 2026 (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 dimensional stability of free gingival grafts (FGG) and to investigate the relationship between graft shrinkage (GS) and the histological and biochemical characteristics of grafts reharvested from the same palatal donor site. The primary objective is to investigate the relationship between histological alterations in grafts reharvested from the same donor site and graft shrinkage at the recipient site.
This study is designed as a split-mouth study in which FGGs are applied to contralateral recipient sites within the same patient. Each participant will receive two grafts: an initial graft harvested from the palatal donor site and a second graft reharvested from the same donor site 63 days after the initial procedure.
Graft dimensional changes will be evaluated using three-dimensional digital measurements. Intraoral digital scans will be obtained at baseline, immediately after surgery, and at 1 and 3 months postoperatively. GS will be assessed through superimposition of digital models.
In addition, histological, histomorphometric, and immunohistochemical analyses will be performed on tissue samples obtained from the donor site to evaluate collagen characteristics and epithelial structure. Furthermore, protein expression levels of specific markers, including collagen type I, collagen type III, and alpha-smooth muscle actin (α-SMA), will be assessed. Early wound healing at the recipient site will be evaluated using the Landry healing index at postoperative days 7, 14, and 28. In addition, biological mediators, including transforming growth factor beta 1 (TGF-β1), vascular endothelial growth factor A (VEGF-A), and platelet-derived growth factor (PDGF), will be analyzed in wound exudate samples obtained from the recipient site to biochemically assess the early healing process.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First free gingival graft | – | Procedure: Free gingival graftRecipient sites treated with free gingival grafts harvested from the palatal donor site during the initial surgical procedure. |
| Re-harvested free gingival graft | – | Procedure: Re-harvested free gingival graftRecipient sites treated with free gingival grafts re-harvested from the same palatal donor site 63 days after the initial surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Systemically healthy, non-smoking individuals aged 18-65 years with insufficient keratinized gingiva (<2 mm; Lang \& Löe, 1972) involving the bilateral mandibular canine and/or premolar regions will be included in the study.
Key inclusion criteria (8 listed)
- Individuals aged between 18 and 65 years,
- Absence of any systemic disease that may adversely affect periodontal health and wound healing,
- Non-smokers,
- Periodontally healthy individuals,
- Mean plaque index (PI) score <1 following non-surgical periodontal therapy (NSPT),
Key exclusion criteria (9 listed)
- Presence of any systemic disease contraindicating surgical procedures,
- Use of medications or supplements affecting bleeding or wound healing,
- Presence of uncontrolled diabetes mellitus (HbA1c >7),
- Pregnancy or breastfeeding,
- History of chemotherapy or radiotherapy within the last 6 months,
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 graftFollowing adequate local anesthesia, a horizontal incision will be made at the level of the mucogingival junction to prepare the recipient bed. A split-thickness flap will be elevated without disturbing the periosteum. A free gingival graft will be harvested from the palatal donor site during the initial surgical procedure. The harvested graft will then be transferred to the recipient site, shaped to the desired dimensions, and stabilized with sutures. | Procedure or surgery | First free gingival graft |
| Re-harvested free gingival graftFollowing adequate local anesthesia, a horizontal incision will be made at the level of the mucogingival junction to prepare the recipient bed. A split-thickness flap will be elevated without disturbing the periosteum. A free gingival graft will be reharvested from the same palatal donor site 63 days after the initial surgery. The harvested graft will then be transferred to the recipient site, shaped to the desired dimensions, and stabilized with sutures. | Procedure or surgery | Re-harvested free gingival graft |
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: Postoperative baseline (immediately after surgery)
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.
Histological alterations in free gingival grafts
Time frame: Baseline (initial graft harvesting procedure)
Histomorphometric and immunohistochemical evaluation of epithelial thickness and Type I and Type III collagen ratios in free gingival graft samples obtained from the palatal donor site.
Histological alterations in re-harvested free gingival grafts
Time frame: 63 days after the initial surgery (re-harvesting procedure)
Histomorphometric and immunohistochemical evaluation of epithelial thickness and Type I and Type III collagen ratios in free gingival graft samples reharvested from the same palatal donor site.
16 secondary outcomes
Keratinized mucosa width
Time frame: Baseline (prior to therapy)
Keratinized mucosa width
Time frame: 1st month
Keratinized mucosa width
Time frame: 3rd month
Gingival Recession Width
Time frame: Baseline (prior to therapy)
Gingival Recession Width
Time frame: 1st month
Gingival Recession Width
Time frame: 3rd month
Gingival Thickness
Time frame: Baseline
Gingival Thickness
Time frame: 3rd month
Landry Healing Index
Time frame: 7th day
Landry Healing Index
Time frame: 14th day
Landry Healing Index
Time frame: 28th day
Growth factor levels in wound fluid
Time frame: 3rd day
Growth factor levels in wound fluid
Time frame: 7th day
Protein expression levels in free gingival grafts,
Time frame: Baseline (initial graft harvesting procedure)
Protein expression levels in free gingival grafts
Time frame: 63 days after the initial surgery (re-harvesting procedure)
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 1 Jun 2026.
- Background: PubMed 27330024Keskiner I, Aydogdu A, Balli U, Kaleli AE. Quantitative changes in palatal donor site thickness after free gingival graft harvesting: a pilot study. J Clin Periodontol. 2016 Nov;43(11):976-984. doi: 10.1111/jcpe.12592. Epub 2016 Sep 9.
- Background: PubMed 17294229Hatipoglu H, Keceli HG, Guncu GN, Sengun D, Tozum TF. Vertical and horizontal dimensional evaluation of free gingival grafts in the anterior mandible: a case report series. Clin Oral Investig. 2007 Jun;11(2):107-13. doi: 10.1007/s00784-006-0084-x. Epub 2007 Feb 9.
- Background: PubMed 28824306Pippi R. Post-Surgical Clinical Monitoring of Soft Tissue Wound Healing in Periodontal and Implant Surgery. Int J Med Sci. 2017 Jul 18;14(8):721-728. doi: 10.7150/ijms.19727. eCollection 2017.
- Background: PubMed 11288784Guglielmoni P, Promsudthi A, Tatakis DN, Trombelli L. Intra- and inter-examiner reproducibility in keratinized tissue width assessment with 3 methods for mucogingival junction determination. J Periodontol. 2001 Feb;72(2):134-9. doi: 10.1902/jop.2001.72.2.134.
- Background: PubMed 24640997Zuhr O, Baumer D, Hurzeler M. The addition of soft tissue replacement grafts in plastic periodontal and implant surgery: critical elements in design and execution. J Clin Periodontol. 2014 Apr;41 Suppl 15:S123-42. doi: 10.1111/jcpe.12185.
- Background: PubMed 33448379Parvini P, Galarraga-Vinueza ME, Obreja K, Magini RS, Sader R, Schwarz F. Prospective study assessing three-dimensional changes of mucosal healing following soft tissue augmentation using free gingival grafts. J Periodontol. 2021 Mar;92(3):400-408. doi: 10.1002/JPER.19-0640. Epub 2020 Aug 21.
- Background: PubMed 36583690Tavelli L, Barootchi S, Stefanini M, Zucchelli G, Giannobile WV, Wang HL. Wound healing dynamics, morbidity, and complications of palatal soft-tissue harvesting. Periodontol 2000. 2023 Jun;92(1):90-119. doi: 10.1111/prd.12466. Epub 2022 Dec 30.
- Background: PubMed 24494804Gumus P, Buduneli E. Graft stabilization with cyanoacrylate decreases shrinkage of free gingival grafts. Aust Dent J. 2014 Mar;59(1):57-64. doi: 10.1111/adj.12149. Epub 2014 Feb 4.
- Background: PubMed 16805692Soileau KM, Brannon RB. A histologic evaluation of various stages of palatal healing following subepithelial connective tissue grafting procedures: a comparison of eight cases. J Periodontol. 2006 Jul;77(7):1267-73. doi: 10.1902/jop.2006.050129.
- Background: PubMed 20429648Silva CO, Ribeiro Edel P, Sallum AW, Tatakis DN. Free gingival grafts: graft shrinkage and donor-site healing in smokers and non-smokers. J Periodontol. 2010 May;81(5):692-701. doi: 10.1902/jop.2010.090381.
- Background: PubMed 4507712Lang NP, Loe H. The relationship between the width of keratinized gingiva and gingival health. J Periodontol. 1972 Oct;43(10):623-7. doi: 10.1902/jop.1972.43.10.623. No abstract available.
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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.
Ayşe Ege Selman study chair
Biruni University, Faculty of Dentistry, Department of Periodontology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 8 inclusion and 9 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: opening soon, as of the sponsor's last update on 1 Jun 2026. 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 Ebru Dilmen (+905435673736, 231115001@st.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 6 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 NCT07617987, which also lists 11 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 1 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.