Gingival RecessionsDEEP-RCTNCT07521566
Histological and Clinical Evaluation of De-epithelialized Connective Tissue Grafts Obtained by Different Methods
A study testing Extraoral de-epithelialization Group and Radiofrequency De-epithelialization in people with Gingival Recessions and Gingival Recession, Mucogingival Surgery, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled clinical study aimed to evaluate the effectiveness of two different de-epithelialization techniques-extraoral scalpel and intraoral radiofrequency (RF)-used in the preparation of de-epithelialized connective tissue grafts (De-CTG) for the treatment of gingival recession. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recessions, Gingival Recession, Mucogingival Surgery
- What is being tested?
- Extraoral de-epithelialization Group and Radiofrequency De-epithelialization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Sep 2025to Jun 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntary individuals aged between 18 and 80 years
- Systemically healthy
- Non-smokers
- Patients diagnosed with periodontal health following Phase I therapy, with reduced periodontium both clinically and radiographically
- Presence of Cairo RT I and RT II gingival recession defects involving maxillary and mandibular anterior and premolar teeth
- Presence of at least 1 mm of keratinized gingiva
- Individuals not using any medications that may affect periodontal tissue health or wound healing
- Absence of any pathology in the palatal mucosa that may interfere with the surgical procedure for connective tissue harvesting
Who cannot join
- Teeth with caries, non-carious cervical lesions, or restorations in the gingival recession area
- Teeth with endodontic pathology
- Pregnant or lactating women
- Patients with cardiac pacemakers
- Teeth where the cementoenamel junction cannot be clearly identified
- Individuals for whom the use of a radiofrequency device may pose a risk
- Use of antibiotics or immunosuppressive medications within the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
This randomized controlled clinical study aimed to evaluate the effectiveness of two different de-epithelialization techniques-extraoral scalpel and intraoral radiofrequency (RF)-used in the preparation of de-epithelialized connective tissue grafts (De-CTG) for the treatment of gingival recession. A total of 48 patients were randomly assigned into two groups, and all grafts were applied in combination with coronally advanced flap (CAF) surgery. Clinical and histological outcomes, including epithelial remnants, root coverage, keratinized tissue gain, surgical duration, and postoperative patient comfort, were assessed. The study seeks to identify a reliable, operator-independent method that minimizes epithelial remnants and improves clinical outcomes and patient experience.
Read the detailed description
Gingival recession, defined as the apical displacement of the gingival margin relative to the cementoenamel junction, is a common clinical condition associated with both functional and esthetic concerns. Subepithelial connective tissue grafts (SCTG) combined with coronally advanced flap (CAF) procedures are widely regarded as the gold standard for root coverage, particularly in patients with thin gingival phenotypes. However, SCTGs may contain undesirable components such as adipose tissue, glandular structures, and neural elements, which can negatively affect graft integration and healing.
To overcome these limitations, de-epithelialized connective tissue grafts (De-CTGs) have been introduced as an alternative, offering a more homogeneous connective tissue composition. Despite their advantages, one of the major challenges associated with De-CTGs is the potential presence of residual epithelial remnants, which may impair healing and compromise clinical outcomes.
Various de-epithelialization techniques have been proposed, including the use of scalpels, burs, lasers, and more recently, radiofrequency (RF) devices. RF technology operates at ultra-high frequencies (3-4 MHz) and has been associated with minimal thermal damage, reduced tissue trauma, faster healing, and improved postoperative comfort compared to conventional methods. However, its application as a de-epithelialization technique in connective tissue graft harvesting for gingival recession treatment has not been previously investigated.
The present study was designed as a randomized controlled clinical trial involving 48 patients with gingival recession defects. Participants were randomly allocated into two groups: in the first group, De-CTGs were prepared using an extraoral scalpel technique, while in the second group, de-epithelialization was performed intraorally using an RF device. All grafts were used in conjunction with CAF surgery.
The outcomes of the study were evaluated through both clinical and histological parameters. Clinical assessments included root coverage, keratinized tissue width gain, probing depth, and clinical attachment level. Histological analysis focused on the presence or absence of epithelial remnants within the grafts. Additionally, surgical time and postoperative patient-reported outcomes, such as pain and discomfort, were recorded to assess patient-centered benefits.
The primary objective of this study is to determine an optimal de-epithelialization technique that ensures complete removal of epithelial remnants, provides ease of manipulation regardless of clinician experience, and enhances both clinical success and patient comfort. Furthermore, the study aims to explore the feasibility of RF as a practical, cost-effective, and minimally invasive alternative for graft preparation in periodontal plastic surgery.
- Being tested
- Extraoral de-epithelialization Group, Radiofrequency De-epithelialization
- Keywords
- gingival recession, connective tissue graft, radiofrequency
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extraoral de-epithelialization GroupProcedure or surgery
Extraoral de-epithelialization of connective tissue grafts using a scalpel prior to graft placement.
Radiofrequency De-epithelializationProcedure or surgery
Intraoral de-epithelialization of connective tissue grafts using a radiofrequency device prior to graft placement.
| Study group | Role | What they receive |
|---|---|---|
| Extraoral de-epithelialization Group | Experimental | Participants received de-epithelialized connective tissue grafts prepared using an extraoral scalpel technique in combination with coronally advanced flap surgery for the treatment of gingival recession defects. Receives: Procedure: Extraoral de-epithelialization Group |
| Radiofrequency De-epithelialization Group | Experimental | Participants received de-epithelialized connective tissue grafts prepared using an intraoral radiofrequency (RF) device in combination with coronally advanced flap surgery for the treatment of gingival recession defects. Receives: Procedure: Radiofrequency De-epithelialization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Epithelial Remnants
Histological evaluation of harvested grafts to determine the presence or absence of epithelial remnants after de-epithelialization using scalpel or radiofrequency methods.
Measured: At the time of surgery
Complete Root Coverage
The percentage of gingival recession defects achieving complete root coverage following treatment with de-epithelialized connective tissue grafts prepared using either scalpel or radiofrequency techniques in combination with coronally advanced flap surgery.
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start19 Sep 2025
- Primary completion6 Oct 2025
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Parallel groups
- Model description
- Two parallel groups were included in this randomized controlled clinical trial. Participants were randomly assigned to receive de-epithelialized connective tissue grafts prepared using either an extraoral scalpel technique or an intraoral radiofrequency (RF) device. All interventions were performed in combination with coronally advanced flap surgery for the treatment of gingival recession defects.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayça Muhterem, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521566
- Sponsor's protocol ID
- 691-SBAAEK
- Acronym
- DEEP-RCT
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ozcelik O, Seydaoglu G, Haytac CM. Diode laser for harvesting de-epithelialized palatal graft in the treatment of gingival recession defects: a randomized clinical trial. J Clin Periodontol. 2016 Jan;43(1):63-71. doi: 10.1111/jcpe.12487. Epub 2016 Jan 21.
PubMed 26660000Couso-Queiruga E, Gonzalez-Martin O, Stuhr S, Gamborena I, Chambrone L, Avila-Ortiz G. Comparative histological evaluation of intra- and extraorally de-epithelialized connective tissue graft samples harvested from the posterior palate region. J Periodontol. 2023 May;94(5):652-660. doi: 10.1002/JPER.22-0493. Epub 2023 Jan 30.
PubMed 36582071Azar EL, Rojas MA, Mandalunis P, Gualtieri A, Carranza N. Histological evaluation of subepithelial connective tissue grafts harvested by two different techniques: Preliminary study in humans. Acta Odontol Latinoam. 2019 Apr 1;32(1):10-16.
PubMed 31206569
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological and Clinical Evaluation of De-epithelialized Connective Tissue Grafts Obtained by Different Methods
- ClinicalTrials.gov ID
- NCT07521566
- Acronym / sponsor ID
- DEEP-RCT / 691-SBAAEK
- Keywords
- gingival recession, connective tissue graft, radiofrequency
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 19 Sep 2025 (actual)
- Primary completion
- 6 Oct 2025 (actual)
- Study completion
- Jun 2026 (estimated)
- First posted
- 13 Apr 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.
This randomized controlled clinical study aimed to evaluate the effectiveness of two different de-epithelialization techniques-extraoral scalpel and intraoral radiofrequency (RF)-used in the preparation of de-epithelialized connective tissue grafts (De-CTG) for the treatment of gingival recession. A total of 48 patients were randomly assigned into two groups, and all grafts were applied in combination with coronally advanced flap (CAF) surgery. Clinical and histological outcomes, including epithelial remnants, root coverage, keratinized tissue gain, surgical duration, and postoperative patient comfort, were assessed. The study seeks to identify a reliable, operator-independent method that minimizes epithelial remnants and improves clinical outcomes and patient experience.
Detailed description
Gingival recession, defined as the apical displacement of the gingival margin relative to the cementoenamel junction, is a common clinical condition associated with both functional and esthetic concerns. Subepithelial connective tissue grafts (SCTG) combined with coronally advanced flap (CAF) procedures are widely regarded as the gold standard for root coverage, particularly in patients with thin gingival phenotypes. However, SCTGs may contain undesirable components such as adipose tissue, glandular structures, and neural elements, which can negatively affect graft integration and healing.
To overcome these limitations, de-epithelialized connective tissue grafts (De-CTGs) have been introduced as an alternative, offering a more homogeneous connective tissue composition. Despite their advantages, one of the major challenges associated with De-CTGs is the potential presence of residual epithelial remnants, which may impair healing and compromise clinical outcomes.
Various de-epithelialization techniques have been proposed, including the use of scalpels, burs, lasers, and more recently, radiofrequency (RF) devices. RF technology operates at ultra-high frequencies (3-4 MHz) and has been associated with minimal thermal damage, reduced tissue trauma, faster healing, and improved postoperative comfort compared to conventional methods. However, its application as a de-epithelialization technique in connective tissue graft harvesting for gingival recession treatment has not been previously investigated.
The present study was designed as a randomized controlled clinical trial involving 48 patients with gingival recession defects. Participants were randomly allocated into two groups: in the first group, De-CTGs were prepared using an extraoral scalpel technique, while in the second group, de-epithelialization was performed intraorally using an RF device. All grafts were used in conjunction with CAF surgery.
The outcomes of the study were evaluated through both clinical and histological parameters. Clinical assessments included root coverage, keratinized tissue width gain, probing depth, and clinical attachment level. Histological analysis focused on the presence or absence of epithelial remnants within the grafts. Additionally, surgical time and postoperative patient-reported outcomes, such as pain and discomfort, were recorded to assess patient-centered benefits.
The primary objective of this study is to determine an optimal de-epithelialization technique that ensures complete removal of epithelial remnants, provides ease of manipulation regardless of clinician experience, and enhances both clinical success and patient comfort. Furthermore, the study aims to explore the feasibility of RF as a practical, cost-effective, and minimally invasive alternative for graft preparation in periodontal plastic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel groups were included in this randomized controlled clinical trial. Participants were randomly assigned to receive de-epithelialized connective tissue grafts prepared using either an extraoral scalpel technique or an intraoral radiofrequency (RF) device. All interventions were performed in combination with coronally advanced flap surgery for the treatment of gingival recession defects.
| Arm | Type | Receives |
|---|---|---|
| Extraoral de-epithelialization Group | Experimental | Procedure: Extraoral de-epithelialization GroupParticipants received de-epithelialized connective tissue grafts prepared using an extraoral scalpel technique in combination with coronally advanced flap surgery for the treatment of gingival recession defects. |
| Radiofrequency De-epithelialization Group | Experimental | Procedure: Radiofrequency De-epithelializationParticipants received de-epithelialized connective tissue grafts prepared using an intraoral radiofrequency (RF) device in combination with coronally advanced flap surgery for the treatment of gingival recession defects. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntary individuals aged between 18 and 80 years
- Systemically healthy
- Non-smokers
- Patients diagnosed with periodontal health following Phase I therapy, with reduced periodontium both clinically and radiographically
- Presence of Cairo RT I and RT II gingival recession defects involving maxillary and mandibular anterior and premolar teeth
Key exclusion criteria (7 listed)
- Teeth with caries, non-carious cervical lesions, or restorations in the gingival recession area
- Teeth with endodontic pathology
- Pregnant or lactating women
- Patients with cardiac pacemakers
- Teeth where the cementoenamel junction cannot be clearly identified
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 |
|---|---|---|
| Extraoral de-epithelialization GroupExtraoral de-epithelialization of connective tissue grafts using a scalpel prior to graft placement. | Procedure or surgery | Extraoral de-epithelialization Group |
| Radiofrequency De-epithelializationIntraoral de-epithelialization of connective tissue grafts using a radiofrequency device prior to graft placement. | Procedure or surgery | Radiofrequency De-epithelialization Group |
Primary outcome
Presence of Epithelial Remnants
Time frame: At the time of surgery
Histological evaluation of harvested grafts to determine the presence or absence of epithelial remnants after de-epithelialization using scalpel or radiofrequency methods.
Complete Root Coverage
Time frame: 3-6 months
The percentage of gingival recession defects achieving complete root coverage following treatment with de-epithelialized connective tissue grafts prepared using either scalpel or radiofrequency techniques in combination with coronally advanced flap surgery.
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 Apr 2026.
- Results publication: PubMed 26660000Ozcelik O, Seydaoglu G, Haytac CM. Diode laser for harvesting de-epithelialized palatal graft in the treatment of gingival recession defects: a randomized clinical trial. J Clin Periodontol. 2016 Jan;43(1):63-71. doi: 10.1111/jcpe.12487. Epub 2016 Jan 21.
- Results publication: PubMed 36582071Couso-Queiruga E, Gonzalez-Martin O, Stuhr S, Gamborena I, Chambrone L, Avila-Ortiz G. Comparative histological evaluation of intra- and extraorally de-epithelialized connective tissue graft samples harvested from the posterior palate region. J Periodontol. 2023 May;94(5):652-660. doi: 10.1002/JPER.22-0493. Epub 2023 Jan 30.
- Results publication: PubMed 31206569Azar EL, Rojas MA, Mandalunis P, Gualtieri A, Carranza N. Histological evaluation of subepithelial connective tissue grafts harvested by two different techniques: Preliminary study in humans. Acta Odontol Latinoam. 2019 Apr 1;32(1):10-16.
- Individual participant dataSharing planned: Undecided
Related trials for Gingival Recessions
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
i-PRF-Based Bioactive Matrix vs. Connective Tissue Graft in the Treatment of Gingival Recessions
Gingival Graft, Recession, Gingival
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
Active, not recruiting
Vertically Coronally Advanced Flap Versus Coronally Advanced Flap for Miller Class I Gingival Recession
Gingival Recession
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extraoral de-epithelialization Group and Radiofrequency De-epithelialization in people with Gingival Recessions and Gingival Recession, Mucogingival Surgery, run by Dokuz Eylul 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 7 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 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?
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?
Presence of Epithelial Remnants (time frame: At the time of surgery). The study lists 2 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 NCT07521566, which also lists 3 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 Apr 2026.