Evaluation of Hall Technique and Atraumatic Restorative Treatment for Management of Caries in the Primary Dentition
- Conditions
- Primary Dental Caries
- Interventions
- Other: Hall techniqueOther: Atraumatic restorative treatmentOther: Conventional restorative treatment
- Registration Number
- NCT04367649
- Lead Sponsor
- Nourhan M.Aly
- Brief Summary
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.
- Detailed Description
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 restoration and will serve as a control.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 155
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Children free of any systemic disease or special health care needs.
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Cooperative children ( positive/ definitely positive) according to Frankl's behavior rating scale.
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Children who are willing to participate in the study
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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.
- Clinical signs and symptoms of irreversible pulpilitis.
- Tooth mobility
- Spontaneous pain
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hall technique Hall technique - Atraumatic restorative treatment Atraumatic restorative treatment - Conventional restorative treatment Conventional restorative treatment -
- Primary Outcome Measures
Name Time Method Success of the crown (for Hall and conventional techniques) 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 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 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 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
- Secondary Outcome Measures
Name Time Method Child satisfaction immediately after completion of the dental treatment procedures The patient's perception of the treatment was assessed by using a faces scale modified to represent satisfaction, indifference, or dissatisfaction . A few minutes will be spent before each procedure to establish rapport with the child and to obtain some notion of the child's understanding of the meaning of those schematic facial expressions. After treatment, the child will be instructed to choose the face that best represented how he/she felt during the procedure.
Assessment of oral cleanliness (plaque) 12 months using plaque index of Sillness and Loe. 0: No plaque. 1: A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface. 2: Moderate accumulation of soft deposits within the gingival pocket, or the tooth and gingival margin which can be seen by the naked eye. 3: Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Assessment of the gingival condition 12 months using gingival index of Loe and Sillness. 0: Normal gingival. 1: Mild inflammation; slight change in color and slight edema, no bleeding on probing. 2: Moderate inflammation; redness, edema, glazing and bleeding on probing. 3: Severe inflammation; marked redness, edema, ulcerations and tendency towards spontaneous bleeding.
Trial Locations
- Locations (1)
Faculty of Dentistry, Alexandria University
🇪🇬Alexandria, Egypt