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临床试验/NCT04443972
NCT04443972已完成不适用

Evaluation of Injectable Beta- Tricalcium Phosphate as an Occlusive Barrier Membrane in Treatment of Grade ii Furcation Involvement (Clinical and Radiographic Study)

Hams Hamed Abdelrahman1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2018年4月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
14
试验地点
1
主要终点
change in clinical Attachment Level

研究概览

简要总结

This study will be conducted to evaluate clinically and radiographically the use of PD VitalOs cement® bone graft in the treatment of class II furcation defects comparing with Hydroxyapatite bone graft and biodegradable collagen membrane in the treatment of class II furcation defects.

详细描述

The study is a randomized, controlled clinical trial. Patients were randomly divided into two equal groups, Group I (Test group): included seven Grade II furcation defects treated by beta tricalcium phosphate bone cement only.

Group II (Control group): included seven Grade II furcation defects treated with granulated beta tricalcium phosphate bone graft covered by resorbable collagen membrane.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
30 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • • Presence of a lower molar with critical size grade II furcation defect (15) with a horizontal component of 4 mm and a vertical component of 4 to 6 mm (18), detected using Naber's probe and William's periodontal probe.
  • Patient's age between 30 - 50 years.
  • Both sexes.
  • The patient should be psychologically accepting the procedures.
  • Patients should be systemically free.

排除标准

  • • Uncooperative patients regarding oral hygiene measures performance.
  • Patients with para functional habits.
  • Pregnant or lactating women.
  • Patients who underwent any periodontal surgeries in the study site during the six months prior to study.

结局指标

主要结局

change in clinical Attachment Level

时间窗: at 3 weeks and 6 weeks

The measurements were carried out to the defects selected using an 0.8 mm thick periodontal probe \* with William's calibration, which was marked from (1-10) mm, pocket depth of (1 mm) or less was recorded as (1mm),measurements exceeding (1mm) but less than (2mm) were recorded as (2mm) so that the probing pocket depth was measured to the nearest mm. Probing pocket depth refers to the distance from the gingival margin to the bottom of the pocket. Mesial and distal pockets were measured as well as the furcation from the buccal aspect as close as possible to the contact points, facial and lingual pockets were measured at midline of roots. Efforts were made to insert the probe parallel to the long axis of the roots. Light force was used during the introduction of the probe to the bottom of the pocket, third molars and teeth with enamel projections were excluded. (7)

change in plaque index scores (PI) according to Silness and Löe.

时间窗: at 3 weeks and 6 weeks

Score 0 = no plaque in gingival area. Score 1= film of plaque adhering to the free gingival margin and the adjacent area of the tooth, plaque may only be recognized by running a probe across the tooth surface. Score 2= moderate accumulation of soft deposits within the gingival pocket and on the gingival margin and/ or adjacent tooth surface which can be seen by the naked eye. Score 3= abundant of soft matter within gingival pocket and/ or the gingival margin and adjacent tooth surface. The scores from the four surfaces of the tooth were added and divided by (four) to give plaque index for each tooth; the plaque index score for an individual was obtained by adding the indices of the teeth and dividing by the number of the teeth examined.

change in probing Pocket Depth(PPD)

时间窗: at 3 weeks and 6 weeks

The measurements were carried out to the defects selected using an 0.8 mm thick periodontal probe \* with William's calibration, which was marked from (1-10) mm, pocket depth of (1 mm) or less was recorded as (1mm),measurements exceeding (1mm) but less than (2mm) were recorded as (2mm) so that the probing pocket depth was measured to the nearest mm. Probing pocket depth refers to the distance from the gingival margin to the bottom of the pocket. Mesial and distal pockets were measured as well as the furcation from the buccal aspect as close as possible to the contact points, facial and lingual pockets were measured at midline of roots. Efforts were made to insert the probe parallel to the long axis of the roots. Light force was used during the introduction of the probe to the bottom of the pocket, third molars and teeth with enamel projections were excluded. (7)

次要结局

  • change in optical density(OD)(at basline, 3 and 6 months)
  • change in radiographic bone level (RBL)(at basline, 3 and 6 months)

研究者

发起方
Hams Hamed Abdelrahman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hams Hamed Abdelrahman

Assistant lecturer

Alexandria University

研究点 (1)

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