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Modified Coronally Advanced Tunnel for Mandibular Lingual Root Coverage

2 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

20

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Carla Sanchez, MS
  • Numero di telefono: 4126241179
  • Email: cab28@pitt.edu

Backup dei contatti dello studio

Luoghi di studio

  • Stati Uniti
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Stati Uniti, 15261
        • University of Pittsburgh School of Dental Medicine
        • Contatto:
          • Carla Sanchez, MS
          • Numero di telefono: 4126241179
          • Email: cab28@pitt.edu
        • Contatto:
        • Investigatore principale:
          • Andrea Ravida, DDS, MS, PhD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Change in Root Coverage from Baseline at 6 Months
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage Root Coverage at 6 Months
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Pittsburgh

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 giugno 2027

Completamento dello studio (Stimato)

1 dicembre 2028

Date di iscrizione allo studio

Primo inviato

1 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 maggio 2026

Primo Inserito (Effettivo)

15 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • STUDY26020003

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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