Gingival Recession, LocalizedNCT06737120
Effect of Modified Free Gingival Graft and Conventional Free Gingival Graft on Gingival Recession
A study testing Mod-fgg and Fgg in people with Gingival Recession, Localized and Keratinized Tissue, run by AYSE HUMEYRA ORUC at 1 site in Turkey (Türkiye).
Trial summary
The aim of this clinical study is to understand whether the modified free gingival graft technique is superior to the conventional free gingival graft: Will gingival recession completely close in modified free gingival grafting areas? Will there be a significant increase in the amount of keratinized gingiva in… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession, Localized, Keratinized Tissue, Free Gingival Graft
- What is being tested?
- Mod-fgg and Fgg
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2024to 30 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be systemically healthy.
- Not smoking.
- Individuals aged 18 years and over.
- Shallow vestibule (≤5 mm).
- The periodontal pocket depth of the tooth/teeth to be treated should be ≤3 mm and the degree of tooth mobility should be ≤1.
- There should be no cervical composite restoration and no caries-free lesions on the teeth to be treated.
- Presence of Cairo Type 1 class gingival recession on the buccal surface of at most 2 of the mandibular incisors.
Who cannot join
- pregnancy
- untreated periodontal disease
- parafunctional habits
- poor oral hygiene (persistent whole mouth plaque index > 20%)
- iodine allergy
- excessive dental crowding or misalignment of teeth.
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: Comparison of Conventional and Modified Free Gingival Graft Techniques in Treating Mandibular Incisor Gingival Recession: a Randomized Clinical Study
The aim of this clinical study is to understand whether the modified free gingival graft technique is superior to the conventional free gingival graft:
Will gingival recession completely close in modified free gingival grafting areas? Will there be a significant increase in the amount of keratinized gingiva in modified free gingival grafting participants compared to traditional free gingival grafting participants? Participants will visit our clinic in the 1st, 3rd and 6th months. Necessary clinical parameter measurements will be made by the clinician.
Read the detailed description
This study will include individuals who come to Necmettin Erbakan University Faculty of Dentistry, Department of Periodontology for various reasons and agree to participate in the study (those who sign the 'informed consent form'). Radiographic and clinical evaluations are routinely performed during the periodontal examination of each patient applying to the periodontology clinic, and routine periodontal status records are taken and archived before and after each planned treatment.
The study was designed as a randomised controlled clinical trial in which 30 patients underwent free gingival grafting (FGG) operation and 30 patients underwent modified free gingival grafting operation (mod-FG). Clinical parameters of the patients were planned to be measured 1 week before, 1 month, 3 months and 6 months after the operation.
The following clinical measurements will be taken by a single investigator at baseline (1 week before surgery) and at 1, 3, 6 and 12 months after surgery:
- Gingival Recession Depth: The distance from the enamel-cementum border to the gingival margin will be measured with an accuracy of 0.1 mm.
- Recession width: The horizontal distance from the widest part of the recession at the enamel-cementum junction to the mesial and distal starting borders, measured with an accuracy of 0.1 mm.
- Keratised Tissue Height: The distance from the gingival margin to the mucogingival junction will be measured with an accuracy of 0.1 mm.
- Papil width: The length of the horizontal line connecting the zenith points of two neighbouring teeth, measured with an accuracy of 0.1 mm.
- Papil height: The length of the vertical distance from the papillary apex to the line passing through the zenith points of the teeth, measured with an accuracy of 0.1 mm.
- Tissue thickness: It will be measured 2 mm apical to the gingival margin in the mid-buccal region under topical anaesthesia with a root canal instrument fitted with a rubber stopper and the distance between the tip of the root canal instrument and the rubber stopper will be measured with a digital caliper.
- Pocket Depth: The distance between the base of the pocket and the free gingival margin will be measured with the help of a periodontal Williams probe at six points for each tooth and the pocket depth will be recorded.
After the initial examination, each person will be given individual oral hygiene instructions and will receive professional dental cleaning, root planing and polishing with a low abrasive polishing paste and a rubber band. Surgical treatment will be planned after adequate personal plaque control has been achieved.
The included participants will be randomly allocated into two groups: conventional free gingival graft (FGG, control) or modified free gingival graft (ModFGG, test). Random allocation will be done in a 1:1 ratio based on a computer-generated number list. Under local anaesthesia, the exposed root surfaces will be cleaned with Gracey curettes and rinsed thoroughly with saline. One of the following two procedures will be performed according to group allocation.
The primary outcome will be the reduction in gingival recession. Sample size calculation will be performed using a 5% significance level and 95% power, assuming that the critical difference in gingival recession reduction between the groups at the end of 12 months is 1.7 mm and the standard deviation is 1.2 mm.
Statistical analysis will be performed using the Statistical Package for the Social Sciences (SPSS) version 23 (IBM Corp., Armonk, NY). Data will be expressed as mean and standard deviation. Data normality will be assessed using the Kolmogorov-Smirnov test. Differences between parameter means in intra-group comparisons of SDG and modSDG groups will be evaluated using One-way ANOVA (Bonferroni post-hoc) test. Differences between the 2 groups in terms of gingival recession, changes in keratinized tissue height and probing depth, and percentage root coverage will be evaluated by regression analysis using time point and group distribution as main and interaction terms. Results will be expressed as predicted values and 95% confidence intervals. p<0.05 will be considered statistically significant.
- Being tested
- Mod-fgg, Fgg
- Keywords
- modified free gingival graft, free gingival graft, gingival recession
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mod-fggProcedure or surgery
Following an intrasulcular incision, 2 mm long horizontal incisions will be made on each side at the level of the gum line. From these incisions, divergent vertical release incisions will be made extending towards the alveolar mucosa. To prepare the recipient area, a thin partial thickness flap will be lifted and then removed. A foil template will be obtained by measuring the dimensions of the resulting area.
A horizontal incision will be made apical to the exposed root area of the target teeth at a distance corresponding to the height of the exposed root surface. Starting from the endpoints of this incision, two more slightly divergent incisions will be made in the coronal direction. Thus, a connective tissue pedicle flap will be formed and carefully separated from the periosteum. The pedicle graft will be turned over the exposed root surface and fixed with bioabsorbable sutures. The palatal graft will be sutured to cover the connective tissue.
FggProcedure or surgery
The surgical procedures to be performed in this group will be the same as in the modified free gingival graft group, but no connective tissue pedicle flap will be performed.
| Study group | Role | What they receive |
|---|---|---|
| modified free gingival graft | Experimental | A connective tissue pedicle flap will be applied before a free gingival graft is placed in the recipient area. Receives: Procedure: Mod-fgg |
| traditional free gingival graft | Experimental | Not described Receives: Procedure: Fgg |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of preoperative periodontal parameters
To determine the baseline condition, preoperative measurement of periodontal parameters (amount of keratinized tissue, papilla height, papilla width, probing pocket depth, amount of recession, tissue thickness) will be recorded in millimeters using a periodontal probe.
Measured: Preoperatively, before the start of treatment.
Preoperative Intraoral Photographs Capture and Evaluation
Intraoral photographs of patients will be taken before surgery. These photographs will be used to meet the situation before and after treatment. The photographs will be taken with a high-performance digital camera under standardized angles and lighting.
Unit of Measurement:
General condition of oral structures (% change rate).
Measured: Preoperatively, before the start of treatment.
gingival index measurement
The status of gingival health will be assessed using the Gingival Index (Loe and Silness, 1963). This measurement will be made to determine the degree of gingival inflammation and will be scored on a scale from 0 (healthy gingiva) to 3 (severe inflammation and bleeding).
Unit of Measurement: 0-3 scale.
Measured: Preoperatively, before the start of treatment.
Plaque Index (PI) measurement
The degree of plaque accumulation on the tooth surfaces will be assessed using the Plaque Index (Silness and Loe, 1964). The assessment will be made on a scale from 0 (no plaque) to 3 (entire tooth surface covered with plaque). This measurement will be used to objectively determine the degree of plaque formation.Unit of Measurement: 0-3 scale.
Measured: Preoperatively, before the start of treatment.
Secondary outcomes (4)
Measurement of Periodontal Parameters
Postoperative measurement of periodontal parameters will be recorded using a periodontal probe in millimeters at 1, 3 and 6 months. The parameters include the amount of keratinized tissue, papilla height, papilla width, probing pocket depth , the amount of recession and tissue thickness.
Measured: 1,3 and 6 months post-operation.
Post-Operative Photographing and Evaluation
After surgery, intraoral photographs of patients will be taken at 1, 3 and 6 months. These photographs will be used to analyze the changes that occur after treatment. The photographs will be taken with a high-resolution digital camera under standardized angles and lighting conditions. The evaluation will be performed using specific parameters to measure aesthetic and functional changes.Unit of Measurement:General condition of oral structures (% change rate).
Measured: 1,3 and 6 months post-operation.
gingival index measurement
The status of gingival health will be assessed using the Gingival Index (Loe and Silness, 1963). This measurement will be made to determine the degree of gingival inflammation and will be scored on a scale from 0 (healthy gingiva) to 3 (severe inflammation and bleeding).
Unit of Measurement: 0-3 scale.
Measured: 1,3 and 6 months post-operation.
Plaque Index (PI) measurement
The degree of plaque accumulation on tooth surfaces will be assessed using the Plaque Index (Silness and Loe, 1964). The measurement will be made on a scale from 0 (no plaque) to 3 (entire tooth surface covered with plaque). This index will be used to evaluate oral hygiene and treatment effectiveness.
Measurement Unit: 0-3 scale.
Measured: 1,3 and 6 months post-operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start30 Dec 2024 (estimated)
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Jul 2025 (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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AYSE HUMEYRA ORUC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, AYSE HUMEYRA ORUC, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737120
- Sponsor's protocol ID
- ModifiedFreeGingivalGraft
- Status last verified
- Dec 2024
- First submitted
- 3 Dec 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Camargo PM, Melnick PR, Kenney EB. The use of free gingival grafts for aesthetic purposes. Periodontol 2000. 2001;27:72-96. doi: 10.1034/j.1600-0757.2001.027001072.x. No abstract available.
PubMed 11551301Carcuac 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 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conventional and Modified Free Gingival Graft Techniques in Treating Mandibular Incisor Gingival Recession: a Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06737120
- Acronym / sponsor ID
- ModifiedFreeGingivalGraft
- Keywords
- modified free gingival graft, free gingival graft, gingival recession
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- AYSE HUMEYRA ORUCUniversity, hospital or other
- Study start
- 30 Dec 2024 (estimated)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 17 Dec 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 aim of this clinical study is to understand whether the modified free gingival graft technique is superior to the conventional free gingival graft:
Will gingival recession completely close in modified free gingival grafting areas? Will there be a significant increase in the amount of keratinized gingiva in modified free gingival grafting participants compared to traditional free gingival grafting participants? Participants will visit our clinic in the 1st, 3rd and 6th months. Necessary clinical parameter measurements will be made by the clinician.
Detailed description
This study will include individuals who come to Necmettin Erbakan University Faculty of Dentistry, Department of Periodontology for various reasons and agree to participate in the study (those who sign the 'informed consent form'). Radiographic and clinical evaluations are routinely performed during the periodontal examination of each patient applying to the periodontology clinic, and routine periodontal status records are taken and archived before and after each planned treatment.
The study was designed as a randomised controlled clinical trial in which 30 patients underwent free gingival grafting (FGG) operation and 30 patients underwent modified free gingival grafting operation (mod-FG). Clinical parameters of the patients were planned to be measured 1 week before, 1 month, 3 months and 6 months after the operation.
The following clinical measurements will be taken by a single investigator at baseline (1 week before surgery) and at 1, 3, 6 and 12 months after surgery:
- Gingival Recession Depth: The distance from the enamel-cementum border to the gingival margin will be measured with an accuracy of 0.1 mm.
- Recession width: The horizontal distance from the widest part of the recession at the enamel-cementum junction to the mesial and distal starting borders, measured with an accuracy of 0.1 mm.
- Keratised Tissue Height: The distance from the gingival margin to the mucogingival junction will be measured with an accuracy of 0.1 mm.
- Papil width: The length of the horizontal line connecting the zenith points of two neighbouring teeth, measured with an accuracy of 0.1 mm.
- Papil height: The length of the vertical distance from the papillary apex to the line passing through the zenith points of the teeth, measured with an accuracy of 0.1 mm.
- Tissue thickness: It will be measured 2 mm apical to the gingival margin in the mid-buccal region under topical anaesthesia with a root canal instrument fitted with a rubber stopper and the distance between the tip of the root canal instrument and the rubber stopper will be measured with a digital caliper.
- Pocket Depth: The distance between the base of the pocket and the free gingival margin will be measured with the help of a periodontal Williams probe at six points for each tooth and the pocket depth will be recorded.
After the initial examination, each person will be given individual oral hygiene instructions and will receive professional dental cleaning, root planing and polishing with a low abrasive polishing paste and a rubber band. Surgical treatment will be planned after adequate personal plaque control has been achieved.
The included participants will be randomly allocated into two groups: conventional free gingival graft (FGG, control) or modified free gingival graft (ModFGG, test). Random allocation will be done in a 1:1 ratio based on a computer-generated number list. Under local anaesthesia, the exposed root surfaces will be cleaned with Gracey curettes and rinsed thoroughly with saline. One of the following two procedures will be performed according to group allocation.
The primary outcome will be the reduction in gingival recession. Sample size calculation will be performed using a 5% significance level and 95% power, assuming that the critical difference in gingival recession reduction between the groups at the end of 12 months is 1.7 mm and the standard deviation is 1.2 mm.
Statistical analysis will be performed using the Statistical Package for the Social Sciences (SPSS) version 23 (IBM Corp., Armonk, NY). Data will be expressed as mean and standard deviation. Data normality will be assessed using the Kolmogorov-Smirnov test. Differences between parameter means in intra-group comparisons of SDG and modSDG groups will be evaluated using One-way ANOVA (Bonferroni post-hoc) test. Differences between the 2 groups in terms of gingival recession, changes in keratinized tissue height and probing depth, and percentage root coverage will be evaluated by regression analysis using time point and group distribution as main and interaction terms. Results will be expressed as predicted values and 95% confidence intervals. p<0.05 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| modified free gingival graft | Experimental | Procedure: Mod-fggA connective tissue pedicle flap will be applied before a free gingival graft is placed in the recipient area. |
| traditional free gingival graft | Experimental | Procedure: Fgg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- To be systemically healthy.
- Not smoking.
- Individuals aged 18 years and over.
- Shallow vestibule (≤5 mm).
- The periodontal pocket depth of the tooth/teeth to be treated should be ≤3 mm and the degree of tooth mobility should be ≤1.
Key exclusion criteria (6 listed)
- pregnancy
- untreated periodontal disease
- parafunctional habits
- poor oral hygiene (persistent whole mouth plaque index > 20%)
- iodine allergy
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 |
|---|---|---|
| Mod-fggFollowing an intrasulcular incision, 2 mm long horizontal incisions will be made on each side at the level of the gum line. From these incisions, divergent vertical release incisions will be made extending towards the alveolar mucosa. To prepare the recipient area, a thin partial thickness flap will be lifted and then removed. A foil template will be obtained by measuring the dimensions of the resulting area. A horizontal incision will be made apical to the exposed root area of the target teeth at a distance corresponding to the height of the exposed root surface. Starting from the endpoints of this incision, two more slightly divergent incisions will be made in the coronal direction. Thus, a connective tissue pedicle flap will be formed and carefully separated from the periosteum. The pedicle graft will be turned over the exposed root surface and fixed with bioabsorbable sutures. The palatal graft will be sutured to cover the connective tissue. | Procedure or surgery | modified free gingival graft |
| FggThe surgical procedures to be performed in this group will be the same as in the modified free gingival graft group, but no connective tissue pedicle flap will be performed. | Procedure or surgery | traditional free gingival graft |
Primary outcome
measurement of preoperative periodontal parameters
Time frame: Preoperatively, before the start of treatment.
To determine the baseline condition, preoperative measurement of periodontal parameters (amount of keratinized tissue, papilla height, papilla width, probing pocket depth, amount of recession, tissue thickness) will be recorded in millimeters using a periodontal probe.
Preoperative Intraoral Photographs Capture and Evaluation
Time frame: Preoperatively, before the start of treatment.
Intraoral photographs of patients will be taken before surgery. These photographs will be used to meet the situation before and after treatment. The photographs will be taken with a high-performance digital camera under standardized angles and lighting. Unit of Measurement: General condition of oral structures (% change rate).
gingival index measurement
Time frame: Preoperatively, before the start of treatment.
The status of gingival health will be assessed using the Gingival Index (Loe and Silness, 1963). This measurement will be made to determine the degree of gingival inflammation and will be scored on a scale from 0 (healthy gingiva) to 3 (severe inflammation and bleeding). Unit of Measurement: 0-3 scale.
Plaque Index (PI) measurement
Time frame: Preoperatively, before the start of treatment.
The degree of plaque accumulation on the tooth surfaces will be assessed using the Plaque Index (Silness and Loe, 1964). The assessment will be made on a scale from 0 (no plaque) to 3 (entire tooth surface covered with plaque). This measurement will be used to objectively determine the degree of plaque formation.Unit of Measurement: 0-3 scale.
4 secondary outcomes
Measurement of Periodontal Parameters
Time frame: 1,3 and 6 months post-operation.
Post-Operative Photographing and Evaluation
Time frame: 1,3 and 6 months post-operation.
gingival index measurement
Time frame: 1,3 and 6 months post-operation.
Plaque Index (PI) measurement
Time frame: 1,3 and 6 months post-operation.
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 17 Dec 2024.
- Background: PubMed 11551301Camargo PM, Melnick PR, Kenney EB. The use of free gingival grafts for aesthetic purposes. Periodontol 2000. 2001;27:72-96. doi: 10.1034/j.1600-0757.2001.027001072.x. No abstract available.
- 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.
- Individual participant dataSharing planned: No
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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 Mod-fgg and Fgg in people with Gingival Recession, Localized and Keratinized Tissue, run by AYSE HUMEYRA ORUC 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 7 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: opening soon, as of the sponsor's last update on 17 Dec 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 ayşe hümeyra oruç (+90 0332 220 00 26, ayse61836@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of preoperative periodontal parameters (time frame: Preoperatively, before the start of treatment.). 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?
On the ClinicalTrials.gov record for NCT06737120, 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 17 Dec 2024.