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临床试验/CTRI/2019/02/017853
CTRI/2019/02/017853已完成不适用

Comparative evaluation of the treatment outcomes of pulpotomy in primary molars using MTA and 3Mixtatin: A randomized clinical trial.

Dr Anam Mushtaq1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2019年1月4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
32
试验地点
1
主要终点
(b) Radiographic success by

研究概览

简要总结

The study was conducted in the Department of Pediatric and Preventive Dentistry, ITS Dental

College, Hospital & Research Centre.  50 teeth were indicated

for pulpotomy in 52 children. After obtaining written consent from their parents /guardians,

75 the teeth were divided into two equal groups (N=25). MTA and 3Mixtatin were used in the two groups. In both the groups, pulpotomy was performed and Clinical and radiographic evaluation was done after three months, six months and at the end of one year.  The overall success rates of 3Mixtatin and MTA were found to be similar and statistically insignificant over the period of 1 year follow up. At the end of the study, the following conclusion was drawn:

ï‚·  no significant difference in the overall success rates of pulpotomy procedure

using MTA and 3Mixtatin over a follow-up period of one year when used for the

management of deeply carious primary teeth with no clinical/radio-graphic signs or

symptoms of irreversible pulp inflammation.

ï‚·  no statistically significant difference in clinical and radiographic success of

MTA and 3Mixtatin at 3rd month, 6th month and at the end of one year.

ï‚· PDL widening was the common radiographic failure in both the groups i.e MTA and

3mixtatin.

ï‚· no clinically significant difference in the overall success rate between

maxillary and mandibular primary molars.

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 Blinded

入排标准

年龄范围
3.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • •Clinically:
  • •History of localized pain lasting for a short duration which subsides upon elimination of causative mechanical or thermal stimulus.
  • •2.Carious lesions involving more than half the dentin thickness.
  • •Recent History of spontaneous pain of momentary duration not exceeding 7 days.
  • •Hemorrhage control achievable within 3-5 minutes during the procedure.
  • •Restorable crown structure Radiographically
  • •Carious lesion approximating pulp.
  • •Absence of any periradicular or furcal pathology.
  • •No pathologic external or internal root resorption.

排除标准

  • •Clinically:
  • •History of lingering, Spontaneous and Nocturnal pain which is continuous even after removal of the stimuli.
  • •Sensitivity to Hot Stimulus.
  • •Tenderness on percussion.
  • •Pathologic tooth mobility.
  • •Vestibular obliteration and swelling in relation to the tooth
  • •Draining sinus tract in relation to the tooth.
  • •Grossly carious teeth with unrestorable crown structure.
  • •Radiographically
  • •Widened PDL space.
  • •More than 1/3rd physiologic root resorption
  • •Presence of periradicularor Periapical radiolucency.
  • •Calcifications within pulp.

结局指标

主要结局

(b) Radiographic success by

时间窗: 3 months, 6 months and 12 months

Maintaining radicular pulp vitality and assessing it clinically by

时间窗: 3 months, 6 months and 12 months

(a)Absence of spontaneous pain and/or sensitivity to percussion and palpation, fistula / swelling, pathological mobility.

时间窗: 3 months, 6 months and 12 months

Absence of periodontal ligament space widening , radiolucency at the periapical region, internal root resorption or external root resorption.

时间窗: 3 months, 6 months and 12 months

次要结局

  • Maintenance of tooth function and asymptomatic state(At the end of 1 year ( 12 months))

研究者

发起方
Dr Anam Mushtaq
申办方类型
Other [self]

研究点 (1)

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