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Modified Coronally Advanced Tunnel for Mandibular Lingual Root Coverage

2. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Carla Sanchez, MS
  • Telefonnummer: 4126241179
  • E-mail: cab28@pitt.edu

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15261
        • University of Pittsburgh School of Dental Medicine
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Andrea Ravida, DDS, MS, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Change in Root Coverage from Baseline at 6 Months
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage Root Coverage at 6 Months
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Pittsburgh

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

1. december 2028

Datoer for studieregistrering

Først indsendt

1. maj 2026

Først indsendt, der opfyldte QC-kriterier

8. maj 2026

Først opslået (Faktiske)

15. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STUDY26020003

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