Gingival Recession, Plastic SurgeryNCT07064603
Clinical Evaluation of (TCAF) Versus (CAF) Combined With Connective Tissue Graft in the Treatment of Multiple RT2 Gingival Recession Sites
A study testing TCAF in people with Gingival Recession, Plastic Surgery, run by Cairo University.
Trial summary
the aim of the study is to evaluate the changes in gingival recession depth reduction following, treatment of multiple RT2 recession with tunnel coronal advanced flap in comparison to coronal advanced flap, both combined with connective tissue graft Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingival Recession, Plastic Surgery
- What is being tested?
- TCAF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Dec 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
- Patients age 18 years or older.
- Multiple adjacent recession defect classified as RT2.
- Patients with healthy systemic condition (Mazzotti et al., 2023).
- An esthetic concern or hypersensitivity associated with GR
- The gingival recessions must have at least 1.5 mm of KTW.
- Presence of an identified CEJ (A step ≤ 1mm of the CEJ level)
Who cannot join
- Full-mouth plaque and bleeding scores >20 (O'Leary et al., 1972)
- Patients with active periodontal disease;
- Intake of any medications known to affect gingival homeostasis or to interfere with wound healing
- Pregnancy and nursing women
- Smokers: a contraindication for any plastic periodontal surgery (Khuller, 2009).
- Absence of cervical restorations, crowding or malalignment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Evaluation of Tunneled Coronally Advanced Flap (TCAF) Versus Coronally Advanced Flap (CAF) Combined With Connective Tissue Graft in the Treatment of Multiple RT2 Gingival Recession Sites: A Randomized Controlled Clinical Trial
the aim of the study is to evaluate the changes in gingival recession depth reduction following, treatment of multiple RT2 recession with tunnel coronal advanced flap in comparison to coronal advanced flap, both combined with connective tissue graft
Read the detailed description
Several techniques for gingival recession defects have been developed for treatment such as are pedicle soft-tissue graft (rotational flap procedures, advanced flap procedure and tunneling), free soft-tissue graft (epithelialized and subepithelial connective tissue graft) and regenerative procedures (barrier membrane or biologic mediators.
The coronally advanced flap and the tunneling technique are the most commonly performed surgical approaches for treating gingival recessions. Barootchi et al. 2024 conducted a clinical study using tunnel coronal advanced flap technique(TCAF) for treating multiple RT2 gingival recession defects ,in order to combine the advantage of both better access and graft stabilization in CAF and the preservation of the integrity of the papilla and better blood supply to the graft present in tunneling technique. From the previous study it was concluded that the combination of both techniques in the same surgical design can improve both the flap and graft vascularization and enhance clinical, esthetic, and patient-reported outcomes. To our knowledge, there is no conducted randomized clinical trials comparing the tunneled coronally advanced flap technique to the coronally advanced flap for gingival depth reduction in multiple RT2 recessions.
So, this clinical trial aims to address this gap of the literature.
- Conditions
- Gingival Recession, Plastic Surgery
- Being tested
- TCAF
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCAFProcedure or surgery
tunnel coronal advanced flap
| Study group | Role | What they receive |
|---|---|---|
| CORONAL ADVANCED FLAP WITH CONNECTIVE TISSUE GRAFT | Active comparator | The surgical papillae will be elevated using split thickness manner while maintaining the blade in a nearly parallel position to the root.
* The flap apical to the exposed root will be elevated in a full-thickness The full thickness flap covers the avascular root exposure.
* The releasing vertical incisions will be elevated protect the underlying bone in the lateral areas of the flap.
* The part of the flap apical to bone exposure will be elevated by split-thickness, this step will be done so it is possible to move the flap passively in the coronal direction.
* To permit the coronal advancement of the flap, all muscle insertions present in the thickness of the flap will be eliminated. This will be done by keeping the blade parallel to the external mucosal surface.
The connective tissue graft, is harvested from the hard palate (donor site) then it will be sutured in the surgical recipient site then covered by the coronal advancement of the flap and suturing it. Receives: Procedure: TCAF |
| Tunnel coronal advanced flap with connective tissue graft | Experimental | only one surgical papilla will be elevated. The papilla chosen for incision must be with the least interproximal attachment loss. A slightly divergent vertical incision extending beyond the mucogingival junction then a horizontal incision at a distance equal to the recession depth plus 1 mm apical to the papilla tip. The other papillae integrity is preserved , and will be detached using tunneling miniblades and papilla elevator. The flap will be tunneled till the planned papilla .Connective tissue graft will be harvested the graft will be inserted underneath the flap and tunneled below the non-incised papillae. The TCAF is coronally advanced and stabilized 2 mm above the CEJ with sling and simple interrupted sutures at the level of the papillae and simple interrupted sutures for the vertical incision Further coronal advancement of the tunneled papilla with a suspended suture around the with a composite stop Receives: Procedure: TCAF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival recession depth reduction (GRD)
Measured: ONE YEAR
Secondary outcomes (9)
Percentage of mean root coverage (MRC %)
Measured: one year
Percentage of complete root coverage (CRC%)
Measured: one year
Gingival Recession width
Measured: one year
Keratinized tissue width (KTW)
Measured: one year
Probing pocket depth
Measured: one year
Root coverage esthetic score
10 is the ideal esthetic score
Zero points will be assigned if the final position of the gingival margin is equal or apical to the previous recession depth (failure of root coverage procedure), irrespective of color, the presence of a scar, MTC, or MGJ.
Zero points will also be assigned when a partial or total loss of interproximal papilla (black triangle) occurred following the treatment
Measured: one year
Volumetric soft tissue changes
Measured: one year
Post-operative pain
Visual Analogue Scale (VAS) with numerical scale from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first 2 weeks postoperatively
Measured: 2 Week post-operative
Post-operative patient satisfaction
A 3-item questionnaire will be given to the patients to be answered using a 7-point answer scale for assessing their satisfaction with the whole surgical procedure and the achieved results of the procedure performed.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival Recession, Plastic SurgeryStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, may mohamed kamal, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064603
- Sponsor's protocol ID
- 2025-17-1
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Tunneled Coronally Advanced Flap (TCAF) Versus Coronally Advanced Flap (CAF) Combined With Connective Tissue Graft in the Treatment of Multiple RT2 Gingival Recession Sites: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07064603
- Acronym / sponsor ID
- 2025-17-1
- Conditions
- Gingival Recession, Plastic Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 14 Jul 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 the study is to evaluate the changes in gingival recession depth reduction following, treatment of multiple RT2 recession with tunnel coronal advanced flap in comparison to coronal advanced flap, both combined with connective tissue graft
Detailed description
Several techniques for gingival recession defects have been developed for treatment such as are pedicle soft-tissue graft (rotational flap procedures, advanced flap procedure and tunneling), free soft-tissue graft (epithelialized and subepithelial connective tissue graft) and regenerative procedures (barrier membrane or biologic mediators.
The coronally advanced flap and the tunneling technique are the most commonly performed surgical approaches for treating gingival recessions. Barootchi et al. 2024 conducted a clinical study using tunnel coronal advanced flap technique(TCAF) for treating multiple RT2 gingival recession defects ,in order to combine the advantage of both better access and graft stabilization in CAF and the preservation of the integrity of the papilla and better blood supply to the graft present in tunneling technique. From the previous study it was concluded that the combination of both techniques in the same surgical design can improve both the flap and graft vascularization and enhance clinical, esthetic, and patient-reported outcomes. To our knowledge, there is no conducted randomized clinical trials comparing the tunneled coronally advanced flap technique to the coronally advanced flap for gingival depth reduction in multiple RT2 recessions.
So, this clinical trial aims to address this gap of the literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CORONAL ADVANCED FLAP WITH CONNECTIVE TISSUE GRAFT | Active comparator | Procedure: TCAFThe surgical papillae will be elevated using split thickness manner while maintaining the blade in a nearly parallel position to the root. * The flap apical to the exposed root will be elevated in a full-thickness The full thickness flap covers the avascular root exposure. * The releasing vertical incisions will be elevated protect the underlying bone in the lateral areas of the flap. * The part of the flap apical to bone exposure will be elevated by split-thickness, this step will be done so it is possible to move the flap passively in the coronal direction. * To permit the coronal advancement of the flap, all muscle insertions present in the thickness of the flap will be eliminated. This will be done by keeping the blade parallel to the external mucosal surface. The connective tissue graft, is harvested from the hard palate (donor site) then it will be sutured in the surgical recipient site then covered by the coronal advancement of the flap and suturing it. |
| Tunnel coronal advanced flap with connective tissue graft | Experimental | Procedure: TCAFonly one surgical papilla will be elevated. The papilla chosen for incision must be with the least interproximal attachment loss. A slightly divergent vertical incision extending beyond the mucogingival junction then a horizontal incision at a distance equal to the recession depth plus 1 mm apical to the papilla tip. The other papillae integrity is preserved , and will be detached using tunneling miniblades and papilla elevator. The flap will be tunneled till the planned papilla .Connective tissue graft will be harvested the graft will be inserted underneath the flap and tunneled below the non-incised papillae. The TCAF is coronally advanced and stabilized 2 mm above the CEJ with sling and simple interrupted sutures at the level of the papillae and simple interrupted sutures for the vertical incision Further coronal advancement of the tunneled papilla with a suspended suture around the with a composite stop |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients age 18 years or older.
- Multiple adjacent recession defect classified as RT2.
- Patients with healthy systemic condition (Mazzotti et al., 2023).
- An esthetic concern or hypersensitivity associated with GR
- The gingival recessions must have at least 1.5 mm of KTW.
Key exclusion criteria (6 listed)
- Full-mouth plaque and bleeding scores >20 (O'Leary et al., 1972)
- Patients with active periodontal disease;
- Intake of any medications known to affect gingival homeostasis or to interfere with wound healing
- Pregnancy and nursing women
- Smokers: a contraindication for any plastic periodontal surgery (Khuller, 2009).
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 |
|---|---|---|
| TCAFtunnel coronal advanced flap | Procedure or surgery | CORONAL ADVANCED FLAP WITH CONNECTIVE TISSUE GRAFT, Tunnel coronal advanced flap with connective tissue graft |
Primary outcome
Gingival recession depth reduction (GRD)
Time frame: ONE YEAR
9 secondary outcomes
Percentage of mean root coverage (MRC %)
Time frame: one year
Percentage of complete root coverage (CRC%)
Time frame: one year
Gingival Recession width
Time frame: one year
Keratinized tissue width (KTW)
Time frame: one year
Probing pocket depth
Time frame: one year
Root coverage esthetic score
Time frame: one year
Volumetric soft tissue changes
Time frame: one year
Post-operative pain
Time frame: 2 Week post-operative
Post-operative patient satisfaction
Time frame: one year
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 16 Jul 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing TCAF in people with Gingival Recession, Plastic Surgery, run by Cairo University.
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 6 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 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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 May Mohamed Kamal (01063392983, may.kamal@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival recession depth reduction (GRD) (time frame: ONE YEAR). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2025.