Gingival Recession, Mucogingival Deformity - Insufficient Keratinized Tissue
Conditions
Keywords
Gingival Recession, Tissue Grafts, Tooth Sensitivity
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
University of Pittsburgh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
A calibrated examiner, blinded to baseline measurements, will perform all post-operative clinical assessments to minimize measurement bias.
Intervention model description
Prospective single-arm case series. All enrolled participants undergo the same surgical intervention (Modified Coronally Advanced Tunnel technique with deepithelialized connective tissue graft) for treatment of mandibular lingual gingival recessions.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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 * Full-mouth plaque score \<20% * Smokes less than 10 cigarettes per day * Adequate mouth opening for lingual access * Sufficient palatal donor tissue thickness (≥2 mm at 2-3 mm from gingival margin)
Exclusion criteria
* 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) * Use of blood thinners * Previous root coverage surgery at treated sites * Teeth with cervical restorations or caries on lingual surfaces * Inadequate attached gingiva (\<1 mm) * Prominent lingual frenum attachment requiring frenectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Root Coverage from Baseline at 6 Months | Baseline and 6 months post-surgery. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Root Coverage at 6 Months | 6 months post-surgery | 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. |
| Frequency of Complete Root Coverage at 6 Months | 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. |
| Change from Baseline in Recession Depth at 6 Months | Baseline and 6 months post-surgery | Recession depth will be measured from the cementoenamel junction to the gingival margin at the mid-lingual aspect using a UNC-15 periodontal probe. |
| Change from Baseline in Recession Width at 6 Months | Baseline and 6 months post-surgery | Recession width will be measured as the mesiodistal width of the recession defect at the cementoenamel junction level. |
| Change from Baseline in Clinical Attachment Level at 6 Months | Baseline and 6 months post-surgery | 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. |
| Change from Baseline in Probing Depth at 6 Months | Baseline and 6 months post-surgery | 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. |
| Change from Baseline in Keratinized Tissue Width at 6 Months | Baseline and 6 months post-surgery | Keratinized tissue width will be measured from the gingival margin to the mucogingival junction using a UNC-15 periodontal probe. |
| Change from Baseline in Gingival Thickness at 6 Months | Baseline and 6 months post-surgery | Gingival thickness will be measured 2 mm apical to the gingival margin using a #15 endodontic file with a rubber stop under local anesthesia. |
| Surgical time (minutes) | Day of surgery | Surgical time will be recorded in minutes from incision to final suture. |
| Number of Participants with Early Post-operative Complications Within 2 Weeks | Up to 2 weeks post-surgery | Early complications will include graft exposure, wound dehiscence, infection, bleeding, or other post-operative complications documented during early healing. |
| Post-operative Pain Score on Visual Analog Scale at Day 7 | Day 7 post-surgery | 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. |
| Functional Impairment Score on Visual Analog Scale at Day 7 | Day 7 post-surgery | 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. |
| Aesthetic Satisfaction Score on Visual Analog Scale at 6 Months | 6 months post-surgery | 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. |
| Overall Treatment Satisfaction Score on Visual Analog Scale at 6 Months | 6 months post-surgery | 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. |
| Willingness to undergo the procedure again (VAS 0-100 mm; higher score = better outcome) | 24 months post-surgery | 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. |
| Change from Baseline in Root Hypersensitivity Score on Visual Analog Scale at 6 Months | Baseline and 6 months post-surgery | 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. |
| Three-Dimensional Soft Tissue Volume Change at 6 Months | Baseline and 6 months post-surgery | 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. |
| Mean Soft Tissue Thickness Change from Intraoral Scans at 6 Months | Baseline and 6 months post-surgery | 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. |
| Long-term Stability of Root Coverage at 24 Months | Baseline and 24 months post-surgery | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAndrea Ravida, DDS, MS, PhD
University of Pittsburgh, Department of Periodontics and Preventive Dentistry
Outcome results
None listed