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Modified Coronally Advanced Tunnel for Mandibular Lingual Root Coverage

27 lipca 2026 zaktualizowane przez: Andrea Ravida, University of Pittsburgh

Clinical Outcomes of Modified Coronally Advanced Tunnel Technique With Deepithelialized Connective Tissue Graft for Mandibular Lingual Root Coverage: A Case Series

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.

Przegląd badań

Status

Rejestracja na zaproszenie

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

20

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Stany Zjednoczone, 15261
        • University of Pittsburgh School of Dental Medicine

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Modified Coronally Advanced Tunnel with Connective Tissue Graft
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.
Procedura: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Mean Change in Root Coverage from Baseline at 6 Months
Ramy czasowe: 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
Baseline and 6 months post-surgery.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Percentage Root Coverage at 6 Months
Ramy czasowe: 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.
6 months post-surgery
Frequency of Complete Root Coverage at 6 Months
Ramy czasowe: 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.
6 months post-surgery
Change from Baseline in Recession Depth at 6 Months
Ramy czasowe: 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.
Baseline and 6 months post-surgery
Change from Baseline in Recession Width at 6 Months
Ramy czasowe: Baseline and 6 months post-surgery
Recession width will be measured as the mesiodistal width of the recession defect at the cementoenamel junction level.
Baseline and 6 months post-surgery
Change from Baseline in Clinical Attachment Level at 6 Months
Ramy czasowe: 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.
Baseline and 6 months post-surgery
Change from Baseline in Probing Depth at 6 Months
Ramy czasowe: 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.
Baseline and 6 months post-surgery
Change from Baseline in Keratinized Tissue Width at 6 Months
Ramy czasowe: 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.
Baseline and 6 months post-surgery
Change from Baseline in Gingival Thickness at 6 Months
Ramy czasowe: 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.
Baseline and 6 months post-surgery
Surgical time (minutes)
Ramy czasowe: Day of surgery
Surgical time will be recorded in minutes from incision to final suture.
Day of surgery
Number of Participants with Early Post-operative Complications Within 2 Weeks
Ramy czasowe: 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.
Up to 2 weeks post-surgery
Post-operative Pain Score on Visual Analog Scale at Day 7
Ramy czasowe: 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.
Day 7 post-surgery
Functional Impairment Score on Visual Analog Scale at Day 7
Ramy czasowe: 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.
Day 7 post-surgery
Aesthetic Satisfaction Score on Visual Analog Scale at 6 Months
Ramy czasowe: 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.
6 months post-surgery
Overall Treatment Satisfaction Score on Visual Analog Scale at 6 Months
Ramy czasowe: 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.
6 months post-surgery
Willingness to undergo the procedure again (VAS 0-100 mm; higher score = better outcome)
Ramy czasowe: 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.
24 months post-surgery
Change from Baseline in Root Hypersensitivity Score on Visual Analog Scale at 6 Months
Ramy czasowe: 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.
Baseline and 6 months post-surgery
Three-Dimensional Soft Tissue Volume Change at 6 Months
Ramy czasowe: 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.
Baseline and 6 months post-surgery
Mean Soft Tissue Thickness Change from Intraoral Scans at 6 Months
Ramy czasowe: 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.
Baseline and 6 months post-surgery
Long-term Stability of Root Coverage at 24 Months
Ramy czasowe: 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.
Baseline and 24 months post-surgery

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Pittsburgh

Śledczy

  • Główny śledczy: Andrea Ravida, DDS, MS, PhD, University of Pittsburgh, Department of Periodontics and Preventive Dentistry

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

23 lipca 2026

Zakończenie podstawowe (Szacowany)

1 lipca 2027

Ukończenie studiów (Szacowany)

1 grudnia 2028

Daty rejestracji na studia

Pierwszy przesłany

1 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

8 maja 2026

Pierwszy wysłany (Rzeczywisty)

15 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

29 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

27 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • STUDY26020003

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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