Evaluation of Hall Technique and Atraumatic Restorative Treatment for Management of Caries in the Primary Dentition (A Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- Success of the crown (for Hall and conventional techniques)
研究概览
简要总结
The aim of the present study is to evaluate both Hall technique and atraumatic restorative technique in comparison to the conventional restorative technique in the management of carious lesions in primary molars.
详细描述
This study is a three arm randomized controlled clinical trial. Eligible children will be selected from the outpatient clinic of Pediatric Dentistry and Public Health Department, Faculty of Dentistry, Alexandria University after securing necessary consents. One hundred and fifty five teeth will be randomly allocated into 3 groups fifty two each. Group I will be assigned to Hall technique Group II will be assigned to atraumatic restorative treatment using Glass ionomer cement, and Group III will be assigned to a conventional stainless steel crown and will serve as a control.
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
- Single (Participant)
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children free of any systemic disease or special health care needs.
- •Cooperative children ( positive/ definitely positive) according to Frankl's behavior rating scale.
- •Children who are willing to participate in the study
- •Tooth inclusion criteria:
- •Primary molar teeth with occlusal or occlusoproximal carious lesions into dentin (International Caries Detection and Assessment System) (ICDAS) codes: 3-5
- •Absence of clinical signs or symptoms of irreversible pulpitis
- •Absence of fistula or abscess near the selected tooth clinically and radiographically
- •Absence of spontaneous pain
- •Absence of pulp exposure
- •Absence of pathological mobility by placing the points of a pair of tweezers in an occlusal fossa, and gently rocking the tooth bucco-lingually.
排除标准
- •Clinical signs and symptoms of irreversible pulpilitis.
- •Tooth mobility
- •Spontaneous pain
研究组 & 干预措施
Atraumatic restorative treatment
干预措施: Atraumatic restorative treatment (Other)
Hall technique
干预措施: Hall technique (Other)
Stainless Steel Crown Restoration (Conventional)
干预措施: Conventional Stainless Steel Crown Restoration (Other)
结局指标
主要结局
Success of the crown (for Hall and conventional techniques)
时间窗: 12 months
The presence of a satisfactory crown will be checked. Loss of the crown, perforated crown or restoration fracture are considered failures.
Success of the atraumatic restorative technique
时间窗: 12 months
Scoring of the restoration between 0-9. 0: Present, satisfactory. 1: Present, slight deficiency at cavity margin of less than 0.5 mm. 2: Present, slight deficiency at cavity margin of 0.5 mm or more. 3: Present, fracture in restoration. 4: Present, fracture in tooth. 5: Present, overextension of approximal margin of 0.5 mm or more. 6: Not present, most or all of restoration missing. 7: Not present, other restorative treatment performed. 8: Not present, tooth is not present. 9: Unable to diagnose. Success scores are 0 and 1, while failure scores are 2-8.
Treatment (restoration) survival
时间窗: 12 months
ART restorations, Hall technique and conventional restorations will be scored as satisfactory will be considered "successful," while those presented minor and/or major failures will be considered as "failed."
Radiographic evaluation of the treatment
时间窗: 12 months
Digital postoperative periapical radiographs will be obtained using a paralleling device to allow for exact and reproducible alignment of the dental film and the X-ray tube at the different follow up intervals. Teeth will be considered radiographically successful if they showed no evidence of radicular radiolucency, internal or external root resorption or periodontal ligament space widening
Success of the crown (for Hall and conventional techniques)
时间窗: 1 week
The presence of a satisfactory crown will be checked. Loss of the crown, perforated crown or restoration fracture are considered failures.
Success of the crown (for Hall and conventional techniques)
时间窗: 1 month
The presence of a satisfactory crown will be checked. Loss of the crown, perforated crown or restoration fracture are considered failures.
Success of the crown (for Hall and conventional techniques)
时间窗: 6 months
The presence of a satisfactory crown will be checked. Loss of the crown, perforated crown or restoration fracture are considered failures.
Success of the atraumatic restorative technique
时间窗: 1 week
Scoring of the restoration between 0-9. 0: Present, satisfactory. 1: Present, slight deficiency at cavity margin of less than 0.5 mm. 2: Present, slight deficiency at cavity margin of 0.5 mm or more. 3: Present, fracture in restoration. 4: Present, fracture in tooth. 5: Present, overextension of approximal margin of 0.5 mm or more. 6: Not present, most or all of restoration missing. 7: Not present, other restorative treatment performed. 8: Not present, tooth is not present. 9: Unable to diagnose. Success scores are 0 and 1, while failure scores are 2-8.
Success of the atraumatic restorative technique
时间窗: 1 month
Scoring of the restoration between 0-9. 0: Present, satisfactory. 1: Present, slight deficiency at cavity margin of less than 0.5 mm. 2: Present, slight deficiency at cavity margin of 0.5 mm or more. 3: Present, fracture in restoration. 4: Present, fracture in tooth. 5: Present, overextension of approximal margin of 0.5 mm or more. 6: Not present, most or all of restoration missing. 7: Not present, other restorative treatment performed. 8: Not present, tooth is not present. 9: Unable to diagnose. Success scores are 0 and 1, while failure scores are 2-8.
Success of the atraumatic restorative technique
时间窗: 6 months
Scoring of the restoration between 0-9. 0: Present, satisfactory. 1: Present, slight deficiency at cavity margin of less than 0.5 mm. 2: Present, slight deficiency at cavity margin of 0.5 mm or more. 3: Present, fracture in restoration. 4: Present, fracture in tooth. 5: Present, overextension of approximal margin of 0.5 mm or more. 6: Not present, most or all of restoration missing. 7: Not present, other restorative treatment performed. 8: Not present, tooth is not present. 9: Unable to diagnose. Success scores are 0 and 1, while failure scores are 2-8.
Treatment (restoration) survival
时间窗: 1 week
ART restorations, Hall technique and conventional restorations will be scored as satisfactory will be considered "successful," while those presented minor and/or major failures will be considered as "failed."
Treatment (restoration) survival
时间窗: 1 month
ART restorations, Hall technique and conventional restorations will be scored as satisfactory will be considered "successful," while those presented minor and/or major failures will be considered as "failed."
Treatment (restoration) survival
时间窗: 6 months
ART restorations, Hall technique and conventional restorations will be scored as satisfactory will be considered "successful," while those presented minor and/or major failures will be considered as "failed."
Radiographic evaluation of the treatment
时间窗: 6 months
Digital postoperative periapical radiographs will be obtained using a paralleling device to allow for exact and reproducible alignment of the dental film and the X-ray tube at the different follow up intervals. Teeth will be considered radiographically successful if they showed no evidence of radicular radiolucency, internal or external root resorption or periodontal ligament space widening
次要结局
- Child satisfaction(immediately after completion of the dental treatment procedures)
- Assessment of oral cleanliness (plaque)(12 months)
- Assessment of the gingival condition(12 months)
- Assessment of the gingival condition(1 month)
- Assessment of oral cleanliness (plaque)(1 week)
- Assessment of oral cleanliness (plaque)(1 month)
- Assessment of oral cleanliness (plaque)(6 months)
- Assessment of the gingival condition(1 week)
- Assessment of the gingival condition(6 months)
研究者
Nourhan M.Aly
Dental Public Health clinical instructor and statistician
University of Alexandria