Modified Coronally Advanced Tunnel for Mandibular Lingual Root Coverage
27 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Inscripción por invitación
Intervención / Tratamiento
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Estimado)
20
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15261
- University of Pittsburgh School of Dental Medicine
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Mean Change in Root Coverage from Baseline at 6 Months
Periodo de tiempo: Baseline and 6 months post-surgery.
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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
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Baseline and 6 months post-surgery.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Percentage Root Coverage at 6 Months
Periodo de tiempo: 6 months post-surgery
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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.
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6 months post-surgery
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Frequency of Complete Root Coverage at 6 Months
Periodo de tiempo: 6 months post-surgery
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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.
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6 months post-surgery
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Change from Baseline in Recession Depth at 6 Months
Periodo de tiempo: Baseline and 6 months post-surgery
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Recession depth will be measured from the cementoenamel junction to the gingival margin at the mid-lingual aspect using a UNC-15 periodontal probe.
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Baseline and 6 months post-surgery
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Change from Baseline in Recession Width at 6 Months
Periodo de tiempo: Baseline and 6 months post-surgery
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Recession width will be measured as the mesiodistal width of the recession defect at the cementoenamel junction level.
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Baseline and 6 months post-surgery
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Change from Baseline in Clinical Attachment Level at 6 Months
Periodo de tiempo: Baseline and 6 months post-surgery
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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.
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Baseline and 6 months post-surgery
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Change from Baseline in Probing Depth at 6 Months
Periodo de tiempo: Baseline and 6 months post-surgery
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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.
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Baseline and 6 months post-surgery
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Change from Baseline in Keratinized Tissue Width at 6 Months
Periodo de tiempo: Baseline and 6 months post-surgery
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Keratinized tissue width will be measured from the gingival margin to the mucogingival junction using a UNC-15 periodontal probe.
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Baseline and 6 months post-surgery
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Change from Baseline in Gingival Thickness at 6 Months
Periodo de tiempo: Baseline and 6 months post-surgery
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Gingival thickness will be measured 2 mm apical to the gingival margin using a #15 endodontic file with a rubber stop under local anesthesia.
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Baseline and 6 months post-surgery
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Surgical time (minutes)
Periodo de tiempo: Day of surgery
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Surgical time will be recorded in minutes from incision to final suture.
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Day of surgery
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Number of Participants with Early Post-operative Complications Within 2 Weeks
Periodo de tiempo: Up to 2 weeks post-surgery
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Early complications will include graft exposure, wound dehiscence, infection, bleeding, or other post-operative complications documented during early healing.
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Up to 2 weeks post-surgery
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Post-operative Pain Score on Visual Analog Scale at Day 7
Periodo de tiempo: Day 7 post-surgery
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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.
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Day 7 post-surgery
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Functional Impairment Score on Visual Analog Scale at Day 7
Periodo de tiempo: Day 7 post-surgery
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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.
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Day 7 post-surgery
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Aesthetic Satisfaction Score on Visual Analog Scale at 6 Months
Periodo de tiempo: 6 months post-surgery
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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.
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6 months post-surgery
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Overall Treatment Satisfaction Score on Visual Analog Scale at 6 Months
Periodo de tiempo: 6 months post-surgery
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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.
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6 months post-surgery
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Willingness to undergo the procedure again (VAS 0-100 mm; higher score = better outcome)
Periodo de tiempo: 24 months post-surgery
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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.
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24 months post-surgery
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Change from Baseline in Root Hypersensitivity Score on Visual Analog Scale at 6 Months
Periodo de tiempo: Baseline and 6 months post-surgery
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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.
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Baseline and 6 months post-surgery
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Three-Dimensional Soft Tissue Volume Change at 6 Months
Periodo de tiempo: Baseline and 6 months post-surgery
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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.
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Baseline and 6 months post-surgery
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Mean Soft Tissue Thickness Change from Intraoral Scans at 6 Months
Periodo de tiempo: Baseline and 6 months post-surgery
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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.
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Baseline and 6 months post-surgery
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Long-term Stability of Root Coverage at 24 Months
Periodo de tiempo: Baseline and 24 months post-surgery
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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.
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Baseline and 24 months post-surgery
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Andrea Ravida, DDS, MS, PhD, University of Pittsburgh, Department of Periodontics and Preventive Dentistry
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Zuhr O, Baumer D, Hurzeler M. The addition of soft tissue replacement grafts in plastic periodontal and implant surgery: critical elements in design and execution. J Clin Periodontol. 2014 Apr;41 Suppl 15:S123-42. doi: 10.1111/jcpe.12185.
- Chambrone L, Tatakis DN. Periodontal soft tissue root coverage procedures: a systematic review from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S8-51. doi: 10.1902/jop.2015.130674.
- Tavelli L, Barootchi S, Nguyen TVN, Tattan M, Ravida A, Wang HL. Efficacy of tunnel technique in the treatment of localized and multiple gingival recessions: A systematic review and meta-analysis. J Periodontol. 2018 Sep;89(9):1075-1090. doi: 10.1002/JPER.18-0066. Epub 2018 Aug 13.
- Aroca S, Keglevich T, Barbieri B, Gera I, Etienne D. Clinical evaluation of a modified coronally advanced flap alone or in combination with a platelet-rich fibrin membrane for the treatment of adjacent multiple gingival recessions: a 6-month study. J Periodontol. 2009 Feb;80(2):244-52. doi: 10.1902/jop.2009.080253.
- Cairo F, Rotundo R, Miller PD, Pini Prato GP. Root coverage esthetic score: a system to evaluate the esthetic outcome of the treatment of gingival recession through evaluation of clinical cases. J Periodontol. 2009 Apr;80(4):705-10. doi: 10.1902/jop.2009.080565.
- Cairo F, Nieri M, Cincinelli S, Mervelt J, Pagliaro U. The interproximal clinical attachment level to classify gingival recessions and predict root coverage outcomes: an explorative and reliability study. J Clin Periodontol. 2011 Jul;38(7):661-6. doi: 10.1111/j.1600-051X.2011.01732.x. Epub 2011 Apr 20.
- Scheyer ET, Sanz M, Dibart S, Greenwell H, John V, Kim DM, Langer L, Neiva R, Rasperini G. Periodontal soft tissue non-root coverage procedures: a consensus report from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S73-6. doi: 10.1902/jop.2015.140377.
- Jepsen S, Caton JG, Albandar JM, Bissada NF, Bouchard P, Cortellini P, Demirel K, de Sanctis M, Ercoli C, Fan J, Geurs NC, Hughes FJ, Jin L, Kantarci A, Lalla E, Madianos PN, Matthews D, McGuire MK, Mills MP, Preshaw PM, Reynolds MA, Sculean A, Susin C, West NX, Yamazaki K. Periodontal manifestations of systemic diseases and developmental and acquired conditions: Consensus report of workgroup 3 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S237-S248. doi: 10.1002/JPER.17-0733.
- Barootchi S, Tavelli L, Zucchelli G, Giannobile WV, Wang HL. Gingival phenotype modification therapies on natural teeth: A network meta-analysis. J Periodontol. 2020 Nov;91(11):1386-1399. doi: 10.1002/JPER.19-0715. Epub 2020 Jun 12.
- Cortellini P, Bissada NF. Mucogingival conditions in the natural dentition: Narrative review, case definitions, and diagnostic considerations. J Periodontol. 2018 Jun;89 Suppl 1:S204-S213. doi: 10.1002/JPER.16-0671.
- Assis G, Nevins M, Kim DM. The Use of Autogenous Gingival Graft for Treatment of Lingual Recession on Mandibular Anterior Teeth. Int J Periodontics Restorative Dent. 2017 Sep/Oct;37(5):667-671. doi: 10.11607/prd.3263.
- Soileau KM. Treatment of a mucogingival defect associated with intraoral piercing. J Am Dent Assoc. 2005 Apr;136(4):490-4. doi: 10.14219/jada.archive.2005.0205.
- Wilcko MT, Wilcko WM, Murphy KG, Carroll WJ, Ferguson DJ, Miley DD, Bouquot JE. Full-thickness flap/subepithelial connective tissue grafting with intramarrow penetrations: three case reports of lingual root coverage. Int J Periodontics Restorative Dent. 2005 Dec;25(6):561-9.
- Zucchelli G, Bentivogli V, Ganz S, Bellone P, Mazzotti C. The connective tissue graft wall technique to improve root coverage and clinical attachment levels in lingual gingival defects. Int J Esthet Dent. 2016;11(4):538-548.
- Mehrotra VK, Triveni MG, Tarun Kumar AB, Chandra RV. Minimally invasive treatment of mandibular anterior lingual defects by vestibular incision subperiosteal tunnel access technique and connective tissue graft: a case report. Clin Adv Periodontics. 2017;7(4):195-200.
- Alves JP, Marques TM, Malta Santos NB, Correia Sousa M, Coutinho Alves C, Correia AR. Lingual Incision Subperiosteal Tunnel Access: Proof of Concept 18-Month Follow-Up. Clin Adv Periodontics. 2019 Dec;9(4):196-202. doi: 10.1002/cap.10072. Epub 2019 Sep 26.
- Yadav VS, Kamra P, Singh N, Chandra RV. Treatment of multiple lingual gingival recession defects in mandibular incisors with modified coronally advanced tunnel technique. Contemp Clin Dent. 2018;9(Suppl 2):S345-9.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
23 de julio de 2026
Finalización primaria (Estimado)
1 de julio de 2027
Finalización del estudio (Estimado)
1 de diciembre de 2028
Fechas de registro del estudio
Enviado por primera vez
1 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
8 de mayo de 2026
Publicado por primera vez (Actual)
15 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
29 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
27 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY26020003
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .