Effectiveness of Micro Connective Tissue Graft for Treatment of Multiple Adjacent Gingival Recession Defects

Официальное название

Tunnel Surgery Combined With a Micro Connective Tissue Graft for the Treatment of Multiple Adjacent Gingival Recession Defects: a Multi-center Randomized Controlled Clinical Trial.

Обзор

The objective of this project is to evaluate 1-year outcomes of treatment of MAGRD using a modified coronally advanced tunnel technique (MCAT) with either conventional CTG (control group) or micro-CTG (test group).

Подробное описание

Gingival recession defects (GRD) present as a partial exposure of the root surface resulting from gingival margin displacement apical to the cemento-enamel junction (CEJ). A variety of surgical methods have been reported to reestablish root coverage, including tunneling techniques and coronally and laterally advanced flaps. As the presence of thin gingival tissues is one of the predisposing factors for GRD, the adjuvant use of subepithelial connective tissue grafts (CTGs) during the surgical correction is often considered. CTGs are thought to contribute to phenotype modification and stability of treatment outcomes and studies have indicated favorable esthetic results and high degrees of root coverage (documented range: 69% to 97%). The procedure does, however, require a suitable donor site. When multiple adjacent teeth exhibit GRDs, the preferred surgical approach should offer the greatest possible root coverage, while limiting drawbacks (i.e., patient morbidity, esthetic problems). Thus, one of the challenges related to coverage of multiple GRDs is the scarcity of donor tissue. In cases when large CTGs are required, additional surgical procedures may even be necessary. As an alternative, a modification of the harvested CTG into multiple "micro-CTGs" is proposed for the treatment of multiple adjacent GRDs (MAGRD). In the present study, the effectiveness and predictability of micro-CTGs will be evaluated in direct comparison to conventional CTGs.

The investigators hypothesise that no statistically significant differences will be observed in terms of % root coverage (primary outcome) and patient satisfaction at 12 months (non-inferiority).

The investigators hypothesise that subjects in the test group (micro-CTG) will report significantly lower morbidity at 1 and 2 weeks post-surgery when compared to controls (superiority).

Вмешательства

• Процедура Coronally Advanced Flap combined with a Connective Tissue Graft
  Multiple adjacent gingival recession defects will be covered by coronally advanced flap combined with a connective tissue graft harvested from the palate.
• Процедура Coronally Advanced Flap combined with micro Connective Tissue Graft
  Multiple adjacent gingival recession defects will be covered by coronally advanced flap combined with multiple micro connective tissue graft harvested from the palate.
• Устройство Division of the Connective Tissue Graft into multiple micro Connective Tissue Grafts
  The harvested connective tissue graft is divided in multiple micro connective tissue grafts with a scalpel blade before being placed on the recipient site.

Первичные конечные точки

• Mean mid-facial recession coverage (mRC) [Срок оценки: up to 1 year]

Вторичные конечные точки (5)

• Complete Root Coverage (CRC) [Срок оценки: up to 1 year]
• Changes of Keratinized Tissue Width (KTW) [Срок оценки: up to 1 year]
• Changes of Gingival Thickness (GT) [Срок оценки: up to 1 year]
• Patient Morbidity [Срок оценки: up to 2 weeks]
• Patient Satisfaction [Срок оценки: up to 1 year]

Критерии участия

Критерии включения

• age ≥18 years,
• systemically healthy,
• presenting with a minimum of 4 and a maximum of 6 adjacent RT1/RT2 recessions, located in the maxilla or mandible with an apico-coronal extension (i.e. recession depth) of ≥2 mm,
• Full-Mouth Plaque Score (FMPS) <20%,
• Full-Mouth Bleeding Score (FMBS) <20%.

Критерии исключения

• pregnancy or lactation,
• tobacco smoking,
• uncontrolled medical condition,
• medication that can affect gingival conditions.
• thick phenotype,
• severe tooth malpositioning,
• uncorrected trauma from toothbrushing,
• a previous history of root coverage procedures
• the presence of furcation defects.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

ОАЭ · 1 центр

• Confident Dubai Palm — Dubai

Публикации

• Consensus report. Mucogingival therapy. Ann Periodontol. 1996 Nov;1(1):702-6. doi: 10.1902/annals.1996.1.1.702. No abstract available. PMID 9118277
• Cairo F. Periodontal plastic surgery of gingival recessions at single and multiple teeth. Periodontol 2000. 2017 Oct;75(1):296-316. doi: 10.1111/prd.12186. PMID 28758301
• Tonetti MS, Jepsen S; Working Group 2 of the European Workshop on Periodontology. Clinical efficacy of periodontal plastic surgery procedures: consensus report of Group 2 of the 10th European Workshop on Periodontology. J Clin Periodontol. 2014 Apr;41 Suppl 15:S36-43. doi: 10.1111/jcpe.12219. PMID 24640999
• Cairo F, Nieri M, Pagliaro U. Efficacy of periodontal plastic surgery procedures in the treatment of localized facial gingival recessions. A systematic review. J Clin Periodontol. 2014 Apr;41 Suppl 15:S44-62. doi: 10.1111/jcpe.12182. PMID 24641000
• Graziani F, Gennai S, Roldan S, Discepoli N, Buti J, Madianos P, Herrera D. Efficacy of periodontal plastic procedures in the treatment of multiple gingival recessions. J Clin Periodontol. 2014 Apr;41 Suppl 15:S63-76. doi: 10.1111/jcpe.12172. PMID 24641002
• Ronco V, Dard M. A novel suturing approach for tissue displacement within minimally invasive periodontal plastic surgery. Clin Case Rep. 2016 Jul 23;4(8):831-7. doi: 10.1002/ccr3.582. eCollection 2016 Aug. PMID 27525096

Идентификаторы

NCT: NCT06030947 · OCarcuac-microCTG

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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