Modified Coronally Advanced Tunnel for Mandibular Lingual Root Coverage
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Pittsburgh
About this trial
This study will follow adults who have gum recession on the tongue side of the lower teeth. Participants will receive a gum surgery called the Modified Coronally Advanced Tunnel technique with a connective tissue graft taken from the roof of the mouth. The study will include 20 participants and will follow them for up to 24 months after surgery. The main outcome is how much of the exposed root is covered 6 months after surgery. The study will also measure gum thickness, gum width, tooth sensitivity, healing, patient comfort, satisfaction, and three-dimensional soft tissue changes using intraoral scans.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-65 years
Single or multiple Cairo RT1 lingual gingival recessions ≥3 mm on mandibular incisors, canines, or premolars
Identifiable CEJ on the lingual aspect
Vital uniradicular teeth
Disqualifiers
Positive urine pregnancy test or self-reported lactation
Smoker more than 10 cigarettes per day
Uncontrolled systemic diseases, at the discretion of the PI (diabetes HbA1c >7%, cardiovascular disease, immunocompromised)
Use of medications affecting periodontal tissues (phenytoin, calcium channel blockers, immunosuppressants)
Trial design
Design model
Single group
Treatments tested in this trial
Modified Coronally Advanced Tunnel with Connective Tissue Graft
Procedure/SurgeryThe procedure consists of lingual tunnel preparation without vertical releasing incisions, followed by placement of a deepithelialized connective tissue graft harvested from the palate. Root surface conditioning may be performed with EDTA gel before graft placement. The graft is positioned to cover the exposed root surface, and the lingual flap is advanced coronally and secured with sutures to achieve stable, tension-free coverage.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Modified Coronally Advanced Tunnel with Connective Tissue GraftExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mean Change in Root Coverage from Baseline at 6 Months
Mean root coverage will be calculated as baseline recession depth minus recession depth at 6 months post-surgery. Recession depth will be measured in millimeters from the cementoenamel junction to the gingival margin at the mid-lingual aspect using a UNC-15 periodontal probe by a calibrated examiner blinded to baseline measurements
Time frame
Baseline and 6 months post-surgery.Secondary outcomes
1
Percentage Root Coverage at 6 Months
Percentage root coverage will be calculated as \[(baseline recession depth minus 6-month recession depth) / baseline recession depth\] × 100. Additional measurements will be collected at 3, 12, 15, 18, 21, and 24 months post-surgery for descriptive analyses.
Time frame
6 months post-surgery2
Frequency of Complete Root Coverage at 6 Months
Recession depth will be measured in millimeters from the cementoenamel junction to the gingival margin at the mid-lingual aspect using a UNC-15 periodontal probe.
Time frame
6 months post-surgery3
Change from Baseline in Recession Depth at 6 Months
Recession depth will be measured from the cementoenamel junction to the gingival margin at the mid-lingual aspect using a UNC-15 periodontal probe.
Time frame
Baseline and 6 months post-surgery4
Change from Baseline in Recession Width at 6 Months
Recession width will be measured as the mesiodistal width of the recession defect at the cementoenamel junction level.
Time frame
Baseline and 6 months post-surgerySponsors and contacts
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Source ClinicalTrials.gov
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