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临床试验/CTRI/2020/06/025950
CTRI/2020/06/025950尚未招募不适用

Comparative Evaluation of Soft Tissue Preservation Using Non Incised Papilla Surgical Approach and Papilla Preservation Technique for Treatment of Intrabony Defects: A Randomized Controlled Trial

Dept of periodontology1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年1月8日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
1)Clinical attachment level gain

研究概览

简要总结

Intrabony defect is defined by the apical location of the base of the pocket with respect to residual alveolar ridge affecting primarily one tooth.

Classification of intrabony defects based on presence of bony walls is, one wall, two wall and three wall defects.

There are different surgical approaches for reconstructive  treatment of intrabony defects like papilla preservation technique, modified papilla preservation technique, entire papilla preservation technique, minimally invasive surgical technique(MIST), Modified Vestibular Incision Subperiosteal Tunnel Approach(M-VISTA) and  Non Incised Papilla Surgical Approach(NIPSA).

Papilla Preservation Technique: In order to preserve the interdental soft tissues for maximum soft tissue coverage following surgical intervention involving treatment of proximal osseous defects, Takei et al. (1985)[5] proposed a surgical approach called papilla preservation technique.

Non Incised Papilla Surgical Approach(NIPSA): - Moreno Rodríguez et al in 2017 introduced NIPSA technique.It is a variant of papilla preservation technique. In this technique an apical approach will be carried out. No incisions will be given at papilla or marginal tissues. In this technique incision will be located intrasulcularly at the level of the marginal tissue and in the area of the papillae, with the subsequent disinsertion of these tissues for the treatment of the periodontal defect.

NIPSA facilitate the treatment of deep intrabony defects, associated with high risk of soft tissue collapse and postsurgery soft tissues shrinkage.

Graft material for regenerative procedure: Ideal graft material for regenerative procedure is autogenous bone graft, but major disadvantage is need for second surgical site and frequent lack of intraoral donor site for sufficient quantities of autogenous bone. So, bone allografts were developed to overcome this disadvantage. Demineralized Freeze Dried Bone Allograft (DFDBA) provides an osteoinductive scaffold due to presence of bone morphogenic

proteins and elicits resorption when implanted in mesenchymal tissues.

Both Papilla Preservation Technique and Non Incised Papilla Surgical Approach are mainly soft tissue preservation technique. There is scarcity in literature with intergroup comparison studies between both techniques so this study is planned.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients diagnosed with localized chronic periodontitis 2) Periodontal lesions with probing pocket depth (PPD) > 5 mm 3) Periodontal pockets with CAL> 5mm 4) Intrabony defect > 3 mm.

排除标准

  • Patients with systemic diseases that contraindicated treatment and under medication that alter wound healing.
  • 2Teeth with incorrect endodontic or restorative Treatment.
  • Patients on anticoagulants and/or with blood diseases.
  • Pregnant or lactating mother and smokers 5)Patients with malocclusion and undergoing orthodontic treatment.

结局指标

主要结局

1)Clinical attachment level gain

时间窗: 3 months and 6 months

2)Tip of the papilla

时间窗: 3 months and 6 months

3)Pocket probing depth

时间窗: 3 months and 6 months

次要结局

  • Gingival recession height(3 months, 6 months)

研究者

发起方
Dept of periodontology
申办方类型
Other [Government Dental College]

研究点 (1)

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