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临床试验/CTRI/2018/03/012621
CTRI/2018/03/012621已完成不适用

A comparative clinical and radiographic evaluation of bidirectionally positioned flap and GTR membrane with bioactive glass in the treatment of mandibular Class II furcation defects-A randomized controltrial

Manipal college of dental sciences Manipal Academy of Higher Education MAHE Mangalore1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2015年12月15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
24
试验地点
1
主要终点
ii.Horizontal probing depth (HPD)

研究概览

简要总结

The study evaluated the treatment outcomes clinically and radiographically of bidirectionally positioned flap (BPF) technique in combination with bioactive glass to open flap debridement with bioresorbable collagen membrane in combination with bioactive glass and open flap debridement alone for the treatment of mandibular molar class II furcation defects. A total of 24 class II furcation defects in 24 patients with mean age of 50.75 were enrolled after satisfying the inclusion and exclusion criteria. Every patient signed the informed consent form. The baseline and six months  postoperative treatment parameters were compared. Within the limiations , it was concluded that, appropriate case selection and treatment planning is the key to achieving the best results in the treatment of class II mandibular molar furcation defects. The BPF technique in combination with a bone graft substitute and bioresorbable membrane in combination with bone graft substitue showed better results in comparision to open flap debridement. The BPF technique in combination with a bone graft substitue may show comparable treatment outcomes with the bioresorbable membrane in combination with bone graft substitute. Future studies are required with longer followups and sample size to make further definitive conclusions in using BPF surgery in combination therapy for molar class II furcation defects.

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 Outcome Assessor Blinded

入排标准

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

入选标准

  • 1.Patients age 20 and more irrespective of gender.
  • 2.Mandibular molars with Class II buccal furcation defects (Hamp et.al.
  • 34 3.Vertical Clinical attachment loss of ≥4mm after initial therapy.
  • 4.Adequate gingival biotype of ≥1mm.

排除标准

  • 1.Tobacco consumption of any type.
  • 2.Immunocompromised individuals.
  • 3.Patients with compromised systemic health and contraindicated for periodontal surgery.
  • 4.History of previous periodontal surgery performed at the site of interest in the past 24 months.
  • 5.Patients undergoing orthodontic treatment.
  • 6.Pregnant or lactating females.
  • 7.Third molars with furcation involvement.
  • 8.Untreated non-vital teeth.

结局指标

主要结局

ii.Horizontal probing depth (HPD)

时间窗: Baseline and six months

i.Vertical probing pocket depth (VPPD)

时间窗: Baseline and six months

iii.Probing Clinical attachment level (PCAL)

时间窗: Baseline and six months

次要结局

  • i. Gingival Recession (GR)(ii. Radiographic furcation depth (RFD))

研究者

发起方
Manipal college of dental sciences Manipal Academy of Higher Education MAHE Mangalore
申办方类型
Private hospital/clinic

研究点 (1)

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