Modified Coronally Advanced Tunnel for Mandibular Lingual Root Coverage

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.

Первичные конечные точки

• Mean Change in Root Coverage from Baseline at 6 Months [Срок оценки: Baseline and 6 months post-surgery.]

Вторичные конечные точки (12)

• Percentage Root Coverage at 6 Months [Срок оценки: 6 months post-surgery]
• Frequency of Complete Root Coverage at 6 Months [Срок оценки: 6 months post-surgery]
• Change from Baseline in Recession Depth at 6 Months [Срок оценки: Baseline and 6 months post-surgery]
• Change from Baseline in Recession Width at 6 Months [Срок оценки: Baseline and 6 months post-surgery]
• Change from Baseline in Clinical Attachment Level at 6 Months [Срок оценки: Baseline and 6 months post-surgery]
• Change from Baseline in Probing Depth at 6 Months [Срок оценки: Baseline and 6 months post-surgery]
• Change from Baseline in Keratinized Tissue Width at 6 Months [Срок оценки: Baseline and 6 months post-surgery]
• Change from Baseline in Gingival Thickness at 6 Months [Срок оценки: Baseline and 6 months post-surgery]
• Surgical time (minutes) [Срок оценки: Day of surgery]
• Number of Participants with Early Post-operative Complications Within 2 Weeks [Срок оценки: Up to 2 weeks post-surgery]
• Post-operative Pain Score on Visual Analog Scale at Day 7 [Срок оценки: Day 7 post-surgery]
• Functional Impairment Score on Visual Analog Scale at Day 7 [Срок оценки: Day 7 post-surgery]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Pittsburgh School of Dental Medicine — Pittsburgh

Публикации

• 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. PMID 21507033
• 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. PMID 19335093
• 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. PMID 19186964
• 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. PMID 29761502
• 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. PMID 25644302
• 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. PMID 24640997
• 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 PMID 29926943
• 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. PMID 25644301

Идентификаторы

NCT: NCT07590960 · STUDY26020003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗