Evaluation of Hall Technique and Atraumatic Restorative Treatment for Management of Caries in the Primary Dentition

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Hall Technique and Atraumatic Restorative Treatment for Management of Caries in the Primary Dentition (A Randomized Controlled Clinical Trial)

Conditions
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Primary Dental Caries

Intervention / Treatment
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* Other: Hall technique
* Other: Atraumatic restorative treatment
* Other: Conventional restorative treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Clinical signs and symptoms of irreversible pulpilitis. Tooth mobility Spontaneous pain

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hall technique<br> | Other: Hall technique<br>* Orthodontic separators will be used to create space for fitting the stainless crown, then removed after 3-5 days Occlusion will be measured assessing the patient's occlusal-vertical dimensions (OVD) using a modified version of van der Zee and van Amerongen method with a millimeter probe measuring the distance from the lowest point of the gingiva, around the lower canine on the vestibular side up to the point where the tip of the upper canine ends in order to assess the degree of overbite after mounting of the crown. The correct crown size will be selected. The crown should cover all the cusps and approaches the contact points, with a slight feeling of spring back. till reaching the gingival margin. Cementation will be done using glass ionomer cement<br>|
| Active Comparator: Atraumatic restorative treatment<br> | Other: Atraumatic restorative treatment<br>* Caries removal using excavators, then restoration using glass ionomer (GIC)<br>|
| Sham Comparator: Conventional restorative treatment<br> | Other: Conventional restorative treatment<br>* Complete caries removal using high-speed hand piece, and an excavator to clear carious dentin from the pulpal wall. Then, stainless steel crown preparation, selection of the proper size with the smallest crown size that completely covers the preparation chosen. The correct occlusogingival crown length will be established. Cementation will be done using glass ionomer cement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of the crown (for Hall and conventional techniques) | The presence of a satisfactory crown will be checked. Loss of the crown, perforated crown or restoration fracture are considered failures. | 1 week | 
| Success of the crown (for Hall and conventional techniques) | The presence of a satisfactory crown will be checked. Loss of the crown, perforated crown or restoration fracture are considered failures. | 1 month | 
| Success of the crown (for Hall and conventional techniques) | The presence of a satisfactory crown will be checked. Loss of the crown, perforated crown or restoration fracture are considered failures. | 6 months | 
| Success of the crown (for Hall and conventional techniques) | The presence of a satisfactory crown will be checked. Loss of the crown, perforated crown or restoration fracture are considered failures. | 12 months | 
| Success of the atraumatic restorative technique | 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. | 1 week | 
| Success of the atraumatic restorative technique | 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. | 1 month | 
| Success of the atraumatic restorative technique | 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. | 6 months | 
| Success of the atraumatic restorative technique | 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. | 12 months | 
| Treatment (restoration) survival | 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. | 1 week | 
| Treatment (restoration) survival | 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. | 1 month | 
| Treatment (restoration) survival | 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. | 6 months | 
| Treatment (restoration) survival | 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. | 12 months | 
| Radiographic evaluation of the treatment | 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 | 6 months | 
| Radiographic evaluation of the treatment | 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 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child satisfaction | 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. | immediately after completion of the dental treatment procedures | 
| Assessment of oral cleanliness (plaque) | 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. | 1 week | 
| Assessment of oral cleanliness (plaque) | 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. | 1 month | 
| Assessment of oral cleanliness (plaque) | 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. | 6 months | 
| Assessment of oral cleanliness (plaque) | 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. | 12 months | 
| Assessment of the gingival condition | 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. | 1 week | 
| Assessment of the gingival condition | 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. | 1 month | 
| Assessment of the gingival condition | 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. | 6 months | 
| Assessment of the gingival condition | 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. | 12 months |