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临床试验/NCT06924203
NCT06924203已完成不适用

Comparison Between Amalgam Restoration and Hall Technique in Treatment of Carious Primary Molars

Suez Canal University2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2019年12月18日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
2
主要终点
Restoration efficiency

研究概览

简要总结

compare between amalgam restoration and hall technique for treatment of decayed primary molars and intervention treatment for decayed primary molars in children, age 3-5 years using split mouth technique in the same child, conventional amalgam restoration and use Stainless steel crown in other side

详细描述

This study wiII be conducted on 30 chiIdren: The moIars wiII be treated by spIit mouth technique.

(AmaIgam group): 30 carious moIars, wiII be restored with (amaIgam) code 4 or 5 (16).

( StainIess steeI crowns group): 30 carious moIars wiII be restored with ((HaII Tech).

  • CIinicaI Assessment:

During follow up periods if:

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

盲法说明

Compare between Amalgam and Hall technique in restoration decyaed primary molars by split mouth technique..

acceptability of Hall technique for care givers and children..

入排标准

年龄范围
3 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Apparently healthy children aged from 3-5 years old of both sexes.
  • cooperative children scored (3 or 4) according to Frankle behavior scale.
  • Informed consent were obtained from parents or care givers.
  • Children had bilateral carious primary molars were scored code 4 or code 5 according to (I.C.D.A.S.C) international caries restorable and evaluation method (split mouth tech).

排除标准

  • Clinical history of spontaneous pain, intra-oral or facial swelling or presence of fistula or sinus tract.
  • Radiographic findings of root resorption, pulp stone, furcation involvement or periapical pathosis as revealed by preoperative periapical radiography.
  • Patients who have any history of hypersensitivity to any of the materials to be used.
  • Parents/children who are uncooperative or refused to participate in the study.

结局指标

主要结局

Restoration efficiency

时间窗: 3 months

Restoration efficiency; Grase \& SmaIis MobiIity Index Grade 0: 0.25 (physioIogic tooth mobiIity). Grade 1: 1 mm (HorizontaI mobiIity). Grade 2: 2 mm (HorizontaI mobiIity). Grade 3: 2 mm (HorizontaI and verticaI mobiIity).

Swelling

时间窗: 12 months

Swelling scores

Pain score

时间窗: 12 months

Pain scores were evaluated VAS pain 10-score scale

Tooth mobility evaluation

时间窗: 12 months

Tooth mobility evaluation; Tooth mobiIity wiII be graded cIinicaIIy by Grace \& SmaIes mobiIity index.

Gingival index

时间窗: 12 months

The GI uses the following scoring system: 0 = normal gingiva; 1. = mild inflammation: slight change in color, slight edema, no bleeding on probing; 2. = moderate inflammation: redness, edema, and glazing, or bleeding on probing; 3. = severe inflammation: marked redness and edema, tendency toward spontaneous bleeding, ulceration.

Radiographic examination

时间窗: 12 months

The radiographs will taken using the Parallel Periapical Technique, will be taken immediately on the first visit post operatively, to act as base line for radiographic evaluation. The following criteria of radiographic assessment will include: 1. ExternaI or internaI root resorption. 2. Inter-radicuIar bone resorption. 3. Widening of the periodontaI Iigament space. 4. PeriapicaI radioIucency. The chiIdren will be recaIIed at the foIIowe up periods at , 3, 6, 9 and12 months to evaIuate periapical radiograoh.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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