Gingival RecessionsNCT07100808
Evaluation of the Clinical Efficacy of De-Epithelialized Free Gingival Graft in the Treatment of Gingival Recessions
A study testing Using the tunnel technique in the treatment of gingival recession in people with Gingival Recessions, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the clinical effectiveness of three techniques used in combination with the tunnel method for the treatment of multiple gingival recessions: subepithelial connective tissue graft (SCTG Group), scalpel-de-epithelialized free gingival graft (Scalpel Group), and Erbium, Chromium… Read more about this study
- Who is it for?
- Ages 19 to 52 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recessions
- What is being tested?
- Using the tunnel technique in the treatment of gingival recession
- 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
- 27 Oct 2021to 24 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 52 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Presence of Miller Class I or II recession defects in at least two adjacent teeth in the maxillary or mandibular arch
- Recession depth ≥ 2 mm
- Recession areas present on intact, caries-free teeth with no restorations
Who cannot join
- ▪ History of periodontal surgery in the target area within the past 6 months
- Use of antibiotics within the past 6 months
- Pregnancy or lactation
- Presence of Miller Class III or IV gingival recession
- Recession defects on molar teeth
- Undergoing orthodontic treatment,
- Presence of parafunctional habits
- Individuals with contraindications for periodontal surgery were excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Clinical Efficacy of Subepithelial Connective Tissue Graft and Free Gingival Graft De-Epithelialized With Two Different Methods in the Treatment of Gingival Recessions
The aim of this study is to evaluate the clinical effectiveness of three techniques used in combination with the tunnel method for the treatment of multiple gingival recessions: subepithelial connective tissue graft (SCTG Group), scalpel-de-epithelialized free gingival graft (Scalpel Group), and Erbium, Chromium: Yttrium-Scandium-Gallium-Garnet (Er,Cr:YSGG) laser-de-epithelialized free gingival graft (Laser Group).
Read the detailed description
Gingival recession is not only one of the most common aesthetic and functional problems of the periodontium, but also one of the most complex conditions in terms of etiology and treatment modalities. Subepithelial connective tissue grafts (SCTG), applied in combination with various techniques, are considered the gold standard in the treatment of gingival recession. In cases where a surgical approach is indicated, coronally advanced flap (CAF) or graft-based subepithelial connective tissue procedures in combination with the tunnel technique (TT) have been reported to be successfully utilized.
The use of de-epithelialized free gingival graft (De-epFGG) as a connective tissue graft (CTG) represents another treatment option for managing gingival recession.
With advancements in laser technology, lasers with various wavelengths are increasingly being used as alternatives to scalpels in numerous intraoral surgical procedures. Considering the advantageous properties of erbium lasers, which are among the most prominent dental lasers, their use has also been demonstrated for preparing recipient sites for free gingival grafts (FGG). There are only a limited number of studies in the literature investigating the combination of De-epithelialized Free Gingival Graft (De-epFGG) with the Tunnel Technique (TT). The aim of this study is to evaluate the clinical effectiveness of SCTG, scalpel-based De-epFGG, and Er,Cr:YSGG laser-based De-epFGG techniques, all applied in combination with the tunnel technique, in the treatment of Miller Class I and II multiple gingival recessions.
The study hypothesis is that the percentage of root coverage achieved using De-epFGG (scalpel and laser methods) would be comparable and that these methods could serve as strong alternatives to SCTG.
- Conditions
- Gingival Recessions
- Being tested
- Using the tunnel technique in the treatment of gingival recession
- Keywords
- Laser Therapy, Gingival Recession, autografts
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using the tunnel technique in the treatment of gingival recessionProcedure or surgery
Also called Mucogingival surgery
Microsurgical periodontal instruments were used during surgical procedures. In this study, specially developed tunnel instruments (Helmunt Zepf, Seitingen-Oberflacht, Germany) were used to mobilize the gingivo-papillary unit and prepare the supraperiosteal tunnel bed. After passing the coronal edge of the alveolar bone with the tunnel instrument placed in the soft tissue, it was advanced towards the apical mucogingival junction with small, circular movements. This procedure was repeated by entering from the sulcus of each tooth. Care was taken to ensure that the prepared flaps were in the same layer and opened towards each other. In the interdental areas, the papillary complex was carefully separated from the periosteum and mobilized in the buccal direction. Thus, mobilization of the entire buccal soft tissue complex was achieved in the coronal direction. After these procedures, it was checked whether the flap covered the recession areas without tension.
| Study group | Role | What they receive |
|---|---|---|
| Subepithelial Connective Tissue Grafts Group | Active comparator | The single incision technique was used as a guide for harvesting the SCTG from the palatal region. After achieving hemostasis in the palatal area, the incision site was primarily closed using 4-0 silk sutures with a cross-suture technique. The graft, held with guide sutures, was slid beneath the interdental papillae and placed into the tunnel bed. The elevated papillary complex was sutured together with the graft using 5-0 monofilament sutures (Neoplene, polypropylene, Turkey) and secured coronally and over the root surface, covering the graft, using vertical double-cross sutures. The surgical procedure, suturing technique, and sutures used on the recipient site were standardized across all groups. Receives: Procedure: Using the tunnel technique in the treatment of gingival recession |
| •Scalpel-based De-epFGG Group | Active comparator | In this group, the De-epFGG technique recommended by Zucchelli et al. was applied. The epithelial layer on the outer surface of the harvested graft was removed by holding a 15C scalpel (Swann-Morton LTD, Sheffield, England) parallel to the surface. The prepared CTG was then placed in the tunnel bed at the desired position using guide sutures. Receives: Procedure: Using the tunnel technique in the treatment of gingival recession |
| Er,Cr:YSGG Laser-based De-epFGG Group | Active comparator | Before the laser application, patients were asked to wear the necessary protective eyewear. The graft dimensions required for the recipient site were marked on the palatal donor area using a 15C scalpel.
The donor site was irradiated with a 2780 nm Er,Cr:YSGG laser (WaterLase iPlus; USA Biolase Technology Inc., Irvine, CA), and the de-epithelialization procedure was completed intraorally. The surface layer formed as a result of the laser application was removed using a moist sponge. Receives: Procedure: Using the tunnel technique in the treatment of gingival recession |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of Root Coverage (RCP)
In this study, the difference between the root surface coverage rate in areas with gingival recession was evaluated by subtracting the 6th month recession depth from the pre-treatment recession depth.
Measured: Baseline and 6 months
Clinical Attachment Level
The distance from the mid-buccal point of the teeth to the groove/pocket base based on the cemento-enamel junction was measured in mm with a periodontal probe.
Measured: baseline and 6th months
Recession Depth
The mid-buccal point of the teeth with gingival recession was measured with a periodontal probe, taking the cemento-enamel junction as the basis, until the coronal part of the gingival margin.
Measured: baseline and 6th month
Width of Keratinized Tissue
Clinically, it is determined by subtracting the distance between the free gingival margin and the mucogingival line from the distance to the groove/pocket base.
Measured: baseline and 6th month
Transgingival Gingival Thickness
In this study, gingival thickness was determined by the transgingival probing method.
Measured: baseline and 6th month
Gingival İndex
Loe ve Silness, 1963 (0-3, skor)
Measured: Baseline and 6th month
Plaque Index
Silness ve Löe, 1966
Measured: baseline and 6th month
Probing Depth
Each tooth was measured from the gingival margin to the sulcus base using a periodontal Williams probe, and probing depths were recorded.
Measured: baseline and 6th month
Secondary outcomes (1)
Oral Health Impact Profile-14 and Provoked Sensitivity (PS),
Postoperative morbidity was assessed using quality of life measurements (Oral Health Impact Profile-14, OHIP-14), provoked sensitivity (PS), and the operation durations of the groups. PS was evaluated preoperatively at the recession sites to detect dentin hypersensitivity by applying a 3-second air spray provocation administered by the clinician.
Measured: baseline and 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start27 Oct 2021
- Primary completion24 Mar 2022
- Study completion24 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gingival RecessionsStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazli Zeynep Alpaslan, Ankara Yildirim Beyazıt University
- Investigators
- Nazlı Z ALPASLAN, Principal investigator, Ankara Yildirim Beyazit University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100808
- Sponsor's protocol ID
- 17.06.2020/14
- Status last verified
- Jul 2025
- First submitted
- 3 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bakhishov H, Isler SC, Bozyel B, Yildirim B, Tekindal MA, Ozdemir B. De-epithelialized gingival graft versus subepithelial connective tissue graft in the treatment of multiple adjacent gingival recessions using the tunnel technique: 1-year results of a randomized clinical trial. J Clin Periodontol. 2021 Jul;48(7):970-983. doi: 10.1111/jcpe.13452. Epub 2021 Apr 7.
PubMed 33751615
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Efficacy of Subepithelial Connective Tissue Graft and Free Gingival Graft De-Epithelialized With Two Different Methods in the Treatment of Gingival Recessions
- ClinicalTrials.gov ID
- NCT07100808
- Acronym / sponsor ID
- 17.06.2020/14
- Conditions
- Gingival Recessions
- Keywords
- Laser Therapy, Gingival Recession, autografts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 24 Mar 2022 (actual)
- Study completion
- 24 Mar 2022 (actual)
- First posted
- 3 Aug 2025 (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 study is to evaluate the clinical effectiveness of three techniques used in combination with the tunnel method for the treatment of multiple gingival recessions: subepithelial connective tissue graft (SCTG Group), scalpel-de-epithelialized free gingival graft (Scalpel Group), and Erbium, Chromium: Yttrium-Scandium-Gallium-Garnet (Er,Cr:YSGG) laser-de-epithelialized free gingival graft (Laser Group).
Detailed description
Gingival recession is not only one of the most common aesthetic and functional problems of the periodontium, but also one of the most complex conditions in terms of etiology and treatment modalities. Subepithelial connective tissue grafts (SCTG), applied in combination with various techniques, are considered the gold standard in the treatment of gingival recession. In cases where a surgical approach is indicated, coronally advanced flap (CAF) or graft-based subepithelial connective tissue procedures in combination with the tunnel technique (TT) have been reported to be successfully utilized.
The use of de-epithelialized free gingival graft (De-epFGG) as a connective tissue graft (CTG) represents another treatment option for managing gingival recession.
With advancements in laser technology, lasers with various wavelengths are increasingly being used as alternatives to scalpels in numerous intraoral surgical procedures. Considering the advantageous properties of erbium lasers, which are among the most prominent dental lasers, their use has also been demonstrated for preparing recipient sites for free gingival grafts (FGG). There are only a limited number of studies in the literature investigating the combination of De-epithelialized Free Gingival Graft (De-epFGG) with the Tunnel Technique (TT). The aim of this study is to evaluate the clinical effectiveness of SCTG, scalpel-based De-epFGG, and Er,Cr:YSGG laser-based De-epFGG techniques, all applied in combination with the tunnel technique, in the treatment of Miller Class I and II multiple gingival recessions.
The study hypothesis is that the percentage of root coverage achieved using De-epFGG (scalpel and laser methods) would be comparable and that these methods could serve as strong alternatives to SCTG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subepithelial Connective Tissue Grafts Group | Active comparator | Procedure: Using the tunnel technique in the treatment of gingival recessionThe single incision technique was used as a guide for harvesting the SCTG from the palatal region. After achieving hemostasis in the palatal area, the incision site was primarily closed using 4-0 silk sutures with a cross-suture technique. The graft, held with guide sutures, was slid beneath the interdental papillae and placed into the tunnel bed. The elevated papillary complex was sutured together with the graft using 5-0 monofilament sutures (Neoplene, polypropylene, Turkey) and secured coronally and over the root surface, covering the graft, using vertical double-cross sutures. The surgical procedure, suturing technique, and sutures used on the recipient site were standardized across all groups. |
| •Scalpel-based De-epFGG Group | Active comparator | Procedure: Using the tunnel technique in the treatment of gingival recessionIn this group, the De-epFGG technique recommended by Zucchelli et al. was applied. The epithelial layer on the outer surface of the harvested graft was removed by holding a 15C scalpel (Swann-Morton LTD, Sheffield, England) parallel to the surface. The prepared CTG was then placed in the tunnel bed at the desired position using guide sutures. |
| Er,Cr:YSGG Laser-based De-epFGG Group | Active comparator | Procedure: Using the tunnel technique in the treatment of gingival recessionBefore the laser application, patients were asked to wear the necessary protective eyewear. The graft dimensions required for the recipient site were marked on the palatal donor area using a 15C scalpel. The donor site was irradiated with a 2780 nm Er,Cr:YSGG laser (WaterLase iPlus; USA Biolase Technology Inc., Irvine, CA), and the de-epithelialization procedure was completed intraorally. The surface layer formed as a result of the laser application was removed using a moist sponge. |
Who may qualify
- Ages
- 19 to 52 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Presence of Miller Class I or II recession defects in at least two adjacent teeth in the maxillary or mandibular arch
- Recession depth ≥ 2 mm
- Recession areas present on intact, caries-free teeth with no restorations
Key exclusion criteria (8 listed)
- ▪ History of periodontal surgery in the target area within the past 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 |
|---|---|---|
| Using the tunnel technique in the treatment of gingival recessionAlso: Mucogingival surgeryMicrosurgical periodontal instruments were used during surgical procedures. In this study, specially developed tunnel instruments (Helmunt Zepf, Seitingen-Oberflacht, Germany) were used to mobilize the gingivo-papillary unit and prepare the supraperiosteal tunnel bed. After passing the coronal edge of the alveolar bone with the tunnel instrument placed in the soft tissue, it was advanced towards the apical mucogingival junction with small, circular movements. This procedure was repeated by entering from the sulcus of each tooth. Care was taken to ensure that the prepared flaps were in the same layer and opened towards each other. In the interdental areas, the papillary complex was carefully separated from the periosteum and mobilized in the buccal direction. Thus, mobilization of the entire buccal soft tissue complex was achieved in the coronal direction. After these procedures, it was checked whether the flap covered the recession areas without tension. | Procedure or surgery | Er,Cr:YSGG Laser-based De-epFGG Group, Subepithelial Connective Tissue Grafts Group, •Scalpel-based De-epFGG Group |
Primary outcome
The percentage of Root Coverage (RCP)
Time frame: Baseline and 6 months
In this study, the difference between the root surface coverage rate in areas with gingival recession was evaluated by subtracting the 6th month recession depth from the pre-treatment recession depth.
Clinical Attachment Level
Time frame: baseline and 6th months
The distance from the mid-buccal point of the teeth to the groove/pocket base based on the cemento-enamel junction was measured in mm with a periodontal probe.
Recession Depth
Time frame: baseline and 6th month
The mid-buccal point of the teeth with gingival recession was measured with a periodontal probe, taking the cemento-enamel junction as the basis, until the coronal part of the gingival margin.
Width of Keratinized Tissue
Time frame: baseline and 6th month
Clinically, it is determined by subtracting the distance between the free gingival margin and the mucogingival line from the distance to the groove/pocket base.
Transgingival Gingival Thickness
Time frame: baseline and 6th month
In this study, gingival thickness was determined by the transgingival probing method.
Gingival İndex
Time frame: Baseline and 6th month
Loe ve Silness, 1963 (0-3, skor)
Plaque Index
Time frame: baseline and 6th month
Silness ve Löe, 1966
Probing Depth
Time frame: baseline and 6th month
Each tooth was measured from the gingival margin to the sulcus base using a periodontal Williams probe, and probing depths were recorded.
1 secondary outcome
Oral Health Impact Profile-14 and Provoked Sensitivity (PS),
Time frame: baseline and 6th month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Results publication: PubMed 33751615Bakhishov H, Isler SC, Bozyel B, Yildirim B, Tekindal MA, Ozdemir B. De-epithelialized gingival graft versus subepithelial connective tissue graft in the treatment of multiple adjacent gingival recessions using the tunnel technique: 1-year results of a randomized clinical trial. J Clin Periodontol. 2021 Jul;48(7):970-983. doi: 10.1111/jcpe.13452. Epub 2021 Apr 7.
- 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. This study is not recruiting at the moment.
Nazlı Z ALPASLAN principal investigator
Ankara Yildirim Beyazit University, Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Using the tunnel technique in the treatment of gingival recession in people with Gingival Recessions, run by Yuzuncu Yil 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 3 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: finished, as of the sponsor's last update on 3 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of Root Coverage (RCP) (time frame: Baseline and 6 months). The study lists 8 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 NCT07100808, which also lists 1 linked publication.
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 3 Aug 2025.