Clinical Evaluation of (TCAF) Versus (CAF) Combined With Connective Tissue Graft in the Treatment of Multiple RT2 Gingival Recession Sites
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
1 other identifier
interventional
22
0 countries
N/A
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2025
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2025
CompletedFirst Posted
Study publicly available on registry
July 14, 2025
CompletedStudy Start
First participant enrolled
October 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
July 16, 2025
July 1, 2025
1.2 years
July 1, 2025
July 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Gingival recession depth reduction (GRD)
ONE YEAR
Secondary Outcomes (9)
Percentage of mean root coverage (MRC %)
one year
Percentage of complete root coverage (CRC%)
one year
Gingival Recession width
one year
Keratinized tissue width (KTW)
one year
Probing pocket depth
one year
- +4 more secondary outcomes
Study Arms (2)
CORONAL ADVANCED FLAP WITH CONNECTIVE TISSUE GRAFT
ACTIVE COMPARATORThe 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
EXPERIMENTALonly 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
Interventions
tunnel coronal advanced flap
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant lecturer
Study Record Dates
First Submitted
July 1, 2025
First Posted
July 14, 2025
Study Start
October 1, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
July 16, 2025
Record last verified: 2025-07