An interventional study of Modified Coronally Advanced Tunnel with Connective Tissue Graft in Gingival Recession and Mucogingival Deformity - Insufficient Keratinized Tissue, sponsored by University of Pittsburgh. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment
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.
This is a single-site prospective case series at the University of Pittsburgh School of Dental Medicine. Adults with single or multiple Cairo RT1 lingual gingival recessions of at least 3 mm on mandibular incisors, canines, or premolars will be enrolled if they meet the study eligibility criteria.
All participants will receive the same surgical treatment. During the procedure, the surgeon will create a tunnel under the gum tissue on the tongue side of the affected lower tooth or teeth. A small piece of tissue will be taken from the palate, prepared as a connective tissue graft, placed under the gum tissue, and stabilized with sutures to help cover the exposed root surface.
Participants will have study visits before surgery, on the day of surgery, during early healing, and at scheduled follow-up visits through 24 months after surgery. The primary outcome will be assessed at 6 months after surgery.
At follow-up visits, the study team will collect gum measurements, assess tooth sensitivity, record healing or post-operative complications, and collect patient-reported outcomes about pain, discomfort, function, appearance, and satisfaction. Intraoral photographs and intraoral scans will also be collected to document healing and measure three-dimensional soft tissue changes over time.
426 studies on the registry are indexed under Gingival Recession; 106 are open to participants now.
This study's planned enrollment of 20 is below the median of 30 across 390 interventional studies indexed under Gingival Recession.
Browse Gingival Recession studies →University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults with single or multiple Cairo RT1 mandibular lingual gingival recessions of at least 3 mm on mandibular incisors, canines, or premolars who will receive standardized Modified Coronally Advanced Tunnel surgery with a deepithelialized connective tissue graft and will be followed for up to 24 months.
Procedure: Modified Coronally Advanced Tunnel with Connective Tissue Graft
The 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.
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.
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-surgery
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-surgery
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-surgery
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-surgery
Change from Baseline in Clinical Attachment Level at 6 Months
Clinical attachment level will be measured from the cementoenamel junction to the base of the sulcus at the treated lingual site using a UNC-15 periodontal probe.
Time frame: Baseline and 6 months post-surgery
Change from Baseline in Probing Depth at 6 Months
Probing depth will be measured from the gingival margin to the base of the sulcus at the treated lingual site using a UNC-15 periodontal probe.
Time frame: Baseline and 6 months post-surgery
Change from Baseline in Keratinized Tissue Width at 6 Months
Keratinized tissue width will be measured from the gingival margin to the mucogingival junction using a UNC-15 periodontal probe.
Time frame: Baseline and 6 months post-surgery
Change from Baseline in Gingival Thickness at 6 Months
Gingival thickness will be measured 2 mm apical to the gingival margin using a #15 endodontic file with a rubber stop under local anesthesia.
Time frame: Baseline and 6 months post-surgery
Surgical time (minutes)
Surgical time will be recorded in minutes from incision to final suture.
Time frame: Day of surgery
Number of Participants with Early Post-operative Complications Within 2 Weeks
Early complications will include graft exposure, wound dehiscence, infection, bleeding, or other post-operative complications documented during early healing.
Time frame: Up to 2 weeks post-surgery
Post-operative Pain Score on Visual Analog Scale at Day 7
Post-operative pain will be assessed using a 100-millimeter visual analog scale, where 0 represents no pain and 100 represents extreme pain. Additional pain assessments will be collected on Days 1 and 3 post-surgery for descriptive analyses.
Time frame: Day 7 post-surgery
Functional Impairment Score on Visual Analog Scale at Day 7
Functional impairment related to speaking, swallowing, or eating will be assessed using a 100-millimeter visual analog scale, where 0 represents no impairment and 100 represents extreme impairment. Additional assessments will be collected on Days 1 and 3 post-surgery for descriptive analyses.
Time frame: Day 7 post-surgery
Aesthetic Satisfaction Score on Visual Analog Scale at 6 Months
Patient satisfaction with the appearance of the treated area will be assessed using a 100-millimeter visual analog scale, where 0 represents extremely unsatisfied and 100 represents extremely satisfied. Additional assessments will be collected at 12 and 24 months post-surgery for descriptive analyses.
Time frame: 6 months post-surgery
Overall Treatment Satisfaction Score on Visual Analog Scale at 6 Months
Overall satisfaction with the treatment outcome will be assessed using a 100-millimeter visual analog scale, where 0 represents extremely unsatisfied and 100 represents extremely satisfied. Additional assessments will be collected at 12 and 24 months post-surgery for descriptive analyses.
Time frame: 6 months post-surgery
Willingness to undergo the procedure again (VAS 0-100 mm; higher score = better outcome)
Participants will rate their willingness to undergo the procedure again using a 100-mm visual analog scale, where 0 represents would not undergo the procedure again and 100 represents definitely would undergo the procedure again.
Time frame: 24 months post-surgery
Change from Baseline in Root Hypersensitivity Score on Visual Analog Scale at 6 Months
Root hypersensitivity will be assessed using a 100-millimeter visual analog scale after an air blast test, where higher scores indicate greater hypersensitivity. Additional assessments will be collected at 12 and 24 months post-surgery for descriptive analyses.
Time frame: Baseline and 6 months post-surgery
Three-Dimensional Soft Tissue Volume Change at 6 Months
Soft tissue volume change will be assessed using intraoral scans exported as STL files. Baseline and 6-month scans will be superimposed, and the absolute volumetric difference within a standardized region of interest will be calculated in cubic millimeters. Additional scans will be collected at 3, 12, and 24 months post-surgery for descriptive analyses.
Time frame: Baseline and 6 months post-surgery
Mean Soft Tissue Thickness Change from Intraoral Scans at 6 Months
Mean tissue thickness change will be calculated as the average perpendicular distance between superimposed baseline and 6-month intraoral scan surfaces within the defined region of interest. Additional scans will be collected at 3, 12, and 24 months post-surgery for descriptive analyses.
Time frame: Baseline and 6 months post-surgery
Long-term Stability of Root Coverage at 24 Months
Long-term stability will be measured as the change in recession depth from baseline to 24 months post-surgery, expressed in millimeters. This outcome assesses whether the root coverage achieved at the 6-month primary endpoint is maintained over the extended follow-up period.
Time frame: Baseline and 24 months post-surgery
Plan to share: No
Started Jul 2026 (actual). Primary completion is estimated for Jul 2027, 12 months after the start.
Of 233 non-industry interventional studies with no phase under Gingival Recession, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 30. This study's planned 12 months is below that.
Counting every sponsor, half of 235 studies reached it within 19 months; a quarter within 11 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
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