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临床试验/CTRI/2019/09/021085
CTRI/2019/09/021085已完成不适用

COMPARISON OF A NOVEL DUAL–VESTIBULAR INCISION SUB PERIOSTEAL ACCESS TECHNIQUE (D-VISTA) WITH A CORONALLY ADVANCED MODIFIED TUNNEL ACCESS TECHNIQUE (CAMT) IN MANAGEMENT OF MULTIPLE MILLERS CLASS III GINGIVAL RECESSION -A RANDOMIZED CONTROLLED CLINICAL TRIAL.

Muthu kumar R1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2019年10月9日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
试验地点
1
主要终点
Depth of gingival recession

研究概览

简要总结

Gingival recession is the exposure of the root surface resulting from the apical migration of the crest of the gingival margin. It may affect single or multiple root surfaces, posing both aesthetic and functional co-morbidities like dentinal hypersensitivity or increased predilection for developing root caries. Further the maintenance of optimal plaque control at areas with irregular gingival margins is a challenge to the patient, establishing higher risk for further periodontal breakdown. Complete coverage of the recession defect and an optimal integration of the covering tissues with the adjacent soft tissues is an essential component of periodontal therapy.

Miller in 1985 proposed a classification system of which the Class III and Class IV had decreasing levels of predictability for complete root coverage. Both these categories, apart from the gingival recession over the radicular surface also had inter-proximal bone and/or soft tissue loss, or mild to severe malocclusion. This patient cohort with inter-proximal bone and soft tissue loss continues to remain the most challenging clinical situation to establish predictable root coverage over the entire denuded root surface. This clinical situation is made even worse when there is multiple teeth with gingival recessions. The current study proposal seeks to address this sub-group of Class III recessions, with gingival recessions on multiple teeth, with inter-proximal bone loss and soft tissue loss. The literature reveals only one controlled clinical trial, which addresses root coverage in this sub-group. This study by Aroca et al (2010), utilized a Modified Sub-Periosteal Tunnelling technique with connective tissue graft as described by Azzi and Etienne. The study reported a CRC percentage of 83%. The current study proposes to utilize an amalgamation of the VISTA technique and the Coronally Advanced Modified Tunnel Technique (CAMT), the modified VISTA (m-VISTA). This technique proposes to utilize a sub-periosteal tunnelling through a vestibular access and a contiguous crevicular access, which will establish a facial sub-periosteal tunnel along with a trans-papillary tunnel, enabling space provision and coronal advancement. Further the technique envisages the utilization of a dual grafting of connective tissue graft over the radicular surface and a L-PRF matrix in the interproximal region, to maximize the capacities of the grafts in these two unique anatomical regions, to synergize the ability to establish root coverage in this complex gingival recession defect.  We introduce this access as the Dual-VISTA Technique (D-VISTA).

The connective tissue graft has long been identified as the gold standard for root coverage, when utilized with an access that would provide a bi laminar blood supply to this graft, while it heals over the avascular root surface, as identified through multiple review articles and meta-analysis (Cairo et al.2014, Tatakis et al.2015). However the utilization of the connective tissue graft to augment the dental papilla, without splitting the papilla is a surgical challenge due to the narrowness of the gingival embrasure space. Further such a connective tissue graft that is tunnelled across the papilla has greater chance of graft strangulation that would therefore compromise graft viability and its ability to augment the interdental gingiva. Therefore the dual grafting that is proposed, seeks to address the peculiar grafting needs in the different zones that present with gingival recession. The L-PRF matrix across the inter-dental gingiva has the ability to remain a viable graft despite the constriction of the graft and compromised vascular supply following the sub-periosteal trans papillary dissection. It would serve to note that the PRF matrix has been proven to be a viable autologous matrix in the augmentation of gingival width and thickness, as well as in the coverage of gingival recession defects as has been previously reported by Aroca S et al in 2009 and Oncu E 2017.

This study is being proposed as split mouth randomized controlled trial, to compare the efficacy of the proposed D-VISTA technique, as compared to a control group managed by CAMT technique in the management of multiple Class III gingival recessions.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Subjects with Class III gingival recession Patient with no contraindications for periodontal surgery and no history of periodontal surgery on the involved sitesSubjects with Full-mouth plaque score of less than 20%; full-mouth bleeding score of less than 20% after phase 1 therapy No occlusal interferences.

排除标准

  • Patients having a Probing Pocket Depth greater than 4mm.
  • Sites with advance bone loss and mobility Subjects having Non-vital teeth, teeth with restoration, Patients undergoing orthodontic treatment Smokers Pregnant patients.

结局指标

主要结局

Depth of gingival recession

时间窗: 6 months

Recession width

时间窗: 6 months

Width of attached gingiva

时间窗: 6 months

Width of keratinized tissue

时间窗: 6 months

Percentage of root coverage

时间窗: 6 months

Percentage of papillary fill

时间窗: 6 months

次要结局

  • Percentage of papillary fill:(Measuring the height and width of papilla at baseline and 6 months post surgically.)

研究者

发起方
Muthu kumar R
申办方类型
Other [Self Funded.]

研究点 (1)

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