Gingival Recession, LocalizedNCT07409558
3D Digital Assessment of Soft Tissue Changes After Modified FGG
A study testing Modified Free Gingival Graft (ModFGG) and Conventional Free Gingival Graft (FGG) in people with Gingival Recession, Localized and Soft Tissue Volume Changes, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this randomized controlled clinical trial is to evaluate the effects of conventional free gingival graft (FGG) and modified free gingival graft (ModFGG) techniques on soft tissue thickness, volumetric change, and creeping attachment in mandibular incisors using three-dimensional direct digital analysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingival Recession, Localized, Soft Tissue Volume Changes, Keratinized Tissue Deficiency
- What is being tested?
- Modified Free Gingival Graft (ModFGG) and Conventional Free Gingival Graft (FGG)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Jan 2025to 31 Jul 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Systemically healthy individuals
- Non-smokers
- Presence of localized Cairo Class II gingival recession with a vertical recession depth of ≥3 mm on the buccal surfaces of mandibular incisors
- Probing pocket depth of ≤3 mm at the tooth/teeth to be treated
- No tooth mobility (mobility grade ≤1)
- Absence of cervical composite restorations or non-carious cervical lesions
- Presence of a shallow vestibule (<5 mm)
Who cannot join
- Pregnancy or lactation
- Untreated periodontal disease
- Presence of parafunctional habits
- Poor oral hygiene, defined as a full-mouth plaque score >20%
- Malpositioned, rotated, or crowded teeth in the buccal position
- Known systemic diseases (e.g., acquired immunodeficiency syndrome, diabetes mellitus)
- Any condition or medication that may affect gingival wound healing
- ASA physical status classification III or higher
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
Kahramanmaraş Sütçü İmam University
Kahramanmaraş, Kahramanmaraş, 46000
esra bozkurt, +905533618725, dtesrabozkurt@gmail.com
About this study
Official title: Three-Dimensional Direct Digital Evaluation of Soft Tissue Volumetric Changes After Modified Free Gingival Graft Surgery: A Randomized Controlled Clinical Trial
The aim of this randomized controlled clinical trial is to evaluate the effects of conventional free gingival graft (FGG) and modified free gingival graft (ModFGG) techniques on soft tissue thickness, volumetric change, and creeping attachment in mandibular incisors using three-dimensional direct digital analysis. The study will include a total of 34 systemically healthy, non-smoking individuals with localized Cairo Class II gingival recession. Participants will be randomly assigned to the FGG (control) and ModFGG (test) groups. Clinical measurements will be performed before surgery and at 1, 3, and 6 months post-surgery. Soft tissue thickness and volumetric changes will be analyzed three-dimensionally by overlaying digital models obtained with an intraoral scanner. Gingival recession depth, keratinized tissue height, and creeping attachment will also be assessed. The aim is to provide clinical evidence regarding the effects of the modified free gingival graft technique on soft tissue stability and volumetric gains.
Read the detailed description
Keratinized tissue deficiency and gingival recession are common mucogingival problems that may compromise periodontal health, esthetics, and patient comfort. Soft tissue grafting procedures are widely used to increase tissue thickness and volume and to achieve keratinized tissue augmentation. Among autogenous grafting techniques, free gingival grafts (FGG) are considered a predictable and reliable approach for enhancing soft tissue stability and long-term marginal tissue outcomes.
Despite their effectiveness, conventional FGG procedures may exhibit postoperative shrinkage and volume reduction due to limited vascularization at the recipient site. To overcome this limitation, a modified free gingival graft (ModFGG) technique has recently been introduced. In this technique, a connective tissue pedicle flap harvested from the apical region of the recession defect is used to cover the exposed root surface prior to placement of the free gingival graft, with the aim of improving graft vascularization and enhancing wound healing. Although previous studies have reported favorable outcomes for ModFGG in terms of root coverage, keratinized tissue gain, and patient satisfaction, available evidence is largely based on two-dimensional clinical measurements.
Conventional methods used to assess soft tissue changes, such as periodontal probing, needles, and ultrasonic devices, are either invasive or limited to linear measurements, thereby restricting the evaluation of volumetric tissue alterations. Recent advances in three-dimensional digital analysis techniques allow for reliable, non-invasive, and reproducible assessment of both linear and volumetric soft tissue changes. However, to date, no clinical study has evaluated soft tissue thickness, volumetric changes, and creeping attachment following conventional FGG and ModFGG procedures in mandibular incisors using direct three-dimensional digital analysis.
This randomized controlled clinical trial aims to compare the effects of conventional free gingival graft and modified free gingival graft techniques on soft tissue thickness, volumetric changes, and creeping attachment in mandibular incisors using a direct three-dimensional digital evaluation method. Systemically healthy, non-smoking adult patients presenting with localized Cairo Class II gingival recession will be enrolled and randomly allocated to either the FGG (control) group or the ModFGG (test) group.
Clinical and digital assessments will be performed at baseline and at 1, 3, and 6 months postoperatively. Soft tissue thickness and volumetric changes will be analyzed by superimposing digital models obtained using an intraoral scanner. Additional clinical parameters, including gingival recession depth, width of keratinized tissue, and probing depth, will also be recorded. The results of this study are expected to provide high-quality evidence regarding the effectiveness of the modified free gingival graft technique in enhancing soft tissue stability and volumetric outcomes in periodontal plastic surgery.
- Being tested
- Modified Free Gingival Graft (ModFGG), Conventional Free Gingival Graft (FGG)
- Keywords
- Modified Free Gingival Graft, Free Gingival Graft, Soft Tissue Volume, Three-Dimensional Digital Analysis
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Free Gingival Graft (ModFGG)Procedure or surgery
A connective tissue pedicle flap is prepared from the apical area of the gingival recession defect and rotated coronally to cover the exposed root surface. Subsequently, a free gingival graft harvested from the palatal donor site is placed over the recipient area to enhance graft vascularization, soft tissue thickness, and volumetric stability.
Conventional Free Gingival Graft (FGG)Procedure or surgery
A free gingival graft harvested from the palatal donor site is placed onto a prepared recipient bed without the use of a connective tissue pedicle flap.
| Study group | Role | What they receive |
|---|---|---|
| Modified Free Gingival Graft (ModFGG) | Experimental | Participants in this arm will receive a modified free gingival graft (ModFGG) procedure.
A connective tissue pedicle flap will be prepared from the apical area of the recession defect and rotated coronally to cover the exposed root surface. A free gingival graft harvested from the palatal donor site will then be placed over the recipient area to enhance graft vascularization, soft tissue thickness, and volumetric stability. Receives: Procedure: Modified Free Gingival Graft (ModFGG) |
| Conventional Free Gingival Graft (FGG) | Active comparator | Participants in this arm will receive a conventional free gingival graft (FGG) procedure.
A free gingival graft harvested from the palatal donor site will be placed onto a prepared recipient bed without the use of a connective tissue pedicle flap. Receives: Procedure: Conventional Free Gingival Graft (FGG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft Tissue Volumetric Changes
Volumetric changes of the recipient site will be evaluated using three-dimensional digital models obtained with an intraoral scanner. Volumetric differences will be calculated by superimposing follow-up scans (1, 3, and 6 months) onto the baseline reference model.
Measured: Baseline, 1 month, 3 months, and 6 months
Secondary outcomes (4)
Creeping Attachment
Creeping attachment will be assessed by linear measurements of coronal migration of the gingival margin relative to the baseline position using calibrated digital images and software analysis.
Measured: Baseline, 1 month, 3 months, and 6 months
Soft Tissue Thickness Gain
Soft tissue thickness will be assessed using three-dimensional direct digital analysis by superimposing intraoral scanner-derived STL files. Horizontal soft tissue thickness measurements will be performed at 1 mm, 3 mm, and 5 mm apical to the baseline gingival margin. Soft tissue thickness gain will be calculated as the difference between baseline and 6-month measurements.
Measured: Baseline and 6 months postoperatively
Gingival Recession Depth
Gingival recession depth will be measured as the distance from the cemento-enamel junction to the gingival margin using calibrated digital photographs.
Measured: Baseline, 1 month, 3 months, and 6 months
Width of Keratinized Tissue
The width of keratinized tissue will be measured from the gingival margin to the mucogingival junction following iodine staining.
Measured: Baseline, 1 month, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start4 Jan 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gingival Recession, LocalizedStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Bozkurt, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409558
- Sponsor's protocol ID
- 2025/01
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The collected data include detailed clinical and digital intraoral scan records that may compromise participant privacy and confidentiality. In addition, informed consent for public data sharing was not obtained from participants.
Publications
Carcuac O, Derks J. Modified Free Gingival Graft Technique for Root Coverage at Mandibular Incisors: A Case Series. Int J Periodontics Restorative Dent. 2021 Mar-Apr;41(2):e37-e44. doi: 10.11607/prd.5398.
PubMed 33819324Carcuac O, Trullenque-Eriksson A, Derks J. Modified free gingival graft technique for treatment of gingival recession defects at mandibular incisors: A randomized clinical trial. J Periodontol. 2023 Jun;94(6):722-730. doi: 10.1002/JPER.22-0581. Epub 2023 Jan 30.
PubMed 36627509
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-Dimensional Direct Digital Evaluation of Soft Tissue Volumetric Changes After Modified Free Gingival Graft Surgery: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07409558
- Acronym / sponsor ID
- 2025/01
- Keywords
- Modified Free Gingival Graft, Free Gingival Graft, Soft Tissue Volume, Three-Dimensional Digital Analysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 4 Jan 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 13 Feb 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 aim of this randomized controlled clinical trial is to evaluate the effects of conventional free gingival graft (FGG) and modified free gingival graft (ModFGG) techniques on soft tissue thickness, volumetric change, and creeping attachment in mandibular incisors using three-dimensional direct digital analysis. The study will include a total of 34 systemically healthy, non-smoking individuals with localized Cairo Class II gingival recession. Participants will be randomly assigned to the FGG (control) and ModFGG (test) groups. Clinical measurements will be performed before surgery and at 1, 3, and 6 months post-surgery. Soft tissue thickness and volumetric changes will be analyzed three-dimensionally by overlaying digital models obtained with an intraoral scanner. Gingival recession depth, keratinized tissue height, and creeping attachment will also be assessed. The aim is to provide clinical evidence regarding the effects of the modified free gingival graft technique on soft tissue stability and volumetric gains.
Detailed description
Keratinized tissue deficiency and gingival recession are common mucogingival problems that may compromise periodontal health, esthetics, and patient comfort. Soft tissue grafting procedures are widely used to increase tissue thickness and volume and to achieve keratinized tissue augmentation. Among autogenous grafting techniques, free gingival grafts (FGG) are considered a predictable and reliable approach for enhancing soft tissue stability and long-term marginal tissue outcomes.
Despite their effectiveness, conventional FGG procedures may exhibit postoperative shrinkage and volume reduction due to limited vascularization at the recipient site. To overcome this limitation, a modified free gingival graft (ModFGG) technique has recently been introduced. In this technique, a connective tissue pedicle flap harvested from the apical region of the recession defect is used to cover the exposed root surface prior to placement of the free gingival graft, with the aim of improving graft vascularization and enhancing wound healing. Although previous studies have reported favorable outcomes for ModFGG in terms of root coverage, keratinized tissue gain, and patient satisfaction, available evidence is largely based on two-dimensional clinical measurements.
Conventional methods used to assess soft tissue changes, such as periodontal probing, needles, and ultrasonic devices, are either invasive or limited to linear measurements, thereby restricting the evaluation of volumetric tissue alterations. Recent advances in three-dimensional digital analysis techniques allow for reliable, non-invasive, and reproducible assessment of both linear and volumetric soft tissue changes. However, to date, no clinical study has evaluated soft tissue thickness, volumetric changes, and creeping attachment following conventional FGG and ModFGG procedures in mandibular incisors using direct three-dimensional digital analysis.
This randomized controlled clinical trial aims to compare the effects of conventional free gingival graft and modified free gingival graft techniques on soft tissue thickness, volumetric changes, and creeping attachment in mandibular incisors using a direct three-dimensional digital evaluation method. Systemically healthy, non-smoking adult patients presenting with localized Cairo Class II gingival recession will be enrolled and randomly allocated to either the FGG (control) group or the ModFGG (test) group.
Clinical and digital assessments will be performed at baseline and at 1, 3, and 6 months postoperatively. Soft tissue thickness and volumetric changes will be analyzed by superimposing digital models obtained using an intraoral scanner. Additional clinical parameters, including gingival recession depth, width of keratinized tissue, and probing depth, will also be recorded. The results of this study are expected to provide high-quality evidence regarding the effectiveness of the modified free gingival graft technique in enhancing soft tissue stability and volumetric outcomes in periodontal plastic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Free Gingival Graft (ModFGG) | Experimental | Procedure: Modified Free Gingival Graft (ModFGG)Participants in this arm will receive a modified free gingival graft (ModFGG) procedure. A connective tissue pedicle flap will be prepared from the apical area of the recession defect and rotated coronally to cover the exposed root surface. A free gingival graft harvested from the palatal donor site will then be placed over the recipient area to enhance graft vascularization, soft tissue thickness, and volumetric stability. |
| Conventional Free Gingival Graft (FGG) | Active comparator | Procedure: Conventional Free Gingival Graft (FGG)Participants in this arm will receive a conventional free gingival graft (FGG) procedure. A free gingival graft harvested from the palatal donor site will be placed onto a prepared recipient bed without the use of a connective tissue pedicle flap. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 years or older
- Systemically healthy individuals
- Non-smokers
- Presence of localized Cairo Class II gingival recession with a vertical recession depth of ≥3 mm on the buccal surfaces of mandibular incisors
- Probing pocket depth of ≤3 mm at the tooth/teeth to be treated
Key exclusion criteria (8 listed)
- Pregnancy or lactation
- Untreated periodontal disease
- Presence of parafunctional habits
- Poor oral hygiene, defined as a full-mouth plaque score >20%
- Malpositioned, rotated, or crowded teeth in the buccal position
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 |
|---|---|---|
| Modified Free Gingival Graft (ModFGG)A connective tissue pedicle flap is prepared from the apical area of the gingival recession defect and rotated coronally to cover the exposed root surface. Subsequently, a free gingival graft harvested from the palatal donor site is placed over the recipient area to enhance graft vascularization, soft tissue thickness, and volumetric stability. | Procedure or surgery | Modified Free Gingival Graft (ModFGG) |
| Conventional Free Gingival Graft (FGG)A free gingival graft harvested from the palatal donor site is placed onto a prepared recipient bed without the use of a connective tissue pedicle flap. | Procedure or surgery | Conventional Free Gingival Graft (FGG) |
Primary outcome
Soft Tissue Volumetric Changes
Time frame: Baseline, 1 month, 3 months, and 6 months
Volumetric changes of the recipient site will be evaluated using three-dimensional digital models obtained with an intraoral scanner. Volumetric differences will be calculated by superimposing follow-up scans (1, 3, and 6 months) onto the baseline reference model.
4 secondary outcomes
Creeping Attachment
Time frame: Baseline, 1 month, 3 months, and 6 months
Soft Tissue Thickness Gain
Time frame: Baseline and 6 months postoperatively
Gingival Recession Depth
Time frame: Baseline, 1 month, 3 months, and 6 months
Width of Keratinized Tissue
Time frame: Baseline, 1 month, 3 months, and 6 months
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 13 Feb 2026.
- Background: PubMed 33819324Carcuac O, Derks J. Modified Free Gingival Graft Technique for Root Coverage at Mandibular Incisors: A Case Series. Int J Periodontics Restorative Dent. 2021 Mar-Apr;41(2):e37-e44. doi: 10.11607/prd.5398.
- Background: PubMed 36627509Carcuac O, Trullenque-Eriksson A, Derks J. Modified free gingival graft technique for treatment of gingival recession defects at mandibular incisors: A randomized clinical trial. J Periodontol. 2023 Jun;94(6):722-730. doi: 10.1002/JPER.22-0581. Epub 2023 Jan 30.
- Kahramanmaraş Sütçü İmam University Clinical Research Ethics CommitteeLink provided by the sponsor.
- Individual participant dataSharing planned: No. The collected data include detailed clinical and digital intraoral scan records that may compromise participant privacy and confidentiality. In addition, informed consent for public data sharing was not obtained from participants.
Related trials for Gingival Recession, Localized
Not yet recruiting
Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
Gingival Recession Localized Moderate, Dental Implant
Recruiting
Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
Diabetes Mellitus, Gingival Recession, Generalized
Not yet recruiting
Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
Soft Tissue Augmentation, Gingival Recession Localized Moderate
Not yet recruiting
Oral Mucosa Wound Healing After Gingival Recession Treatment in Diabetic Patients. A Clinical Study.
Diabetes Mellitus, Gingival Recession, Generalized
Not yet recruiting
Clinical and Histological Evaluation of Subepithelial Connective Tissue Graft Maturation at Different Healing Timepoints, With and Without Topical Application of a Polynucleotide- and Hyaluronic Acid-Based Gel
Gingival Recession, Generalized, Gingival Recession, Localized
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 Modified Free Gingival Graft (ModFGG) and Conventional Free Gingival Graft (FGG) in people with Gingival Recession, Localized and Soft Tissue Volume Changes, run by Kahramanmaras Sutcu Imam 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 8 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 13 Feb 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 esra bozkurt (+905533618725, dtesrabozkurt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Soft Tissue Volumetric Changes (time frame: Baseline, 1 month, 3 months, and 6 months). 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 NCT07409558, which also lists 2 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 13 Feb 2026.