ART Compared to the Hall Technique for Management HSPM

Study Overview
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Brief Summary
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Aims: Evaluation of treatment success on HSPM-affected molars after ART and Hall technique. comparison of pain during treatment with ART and Hall technique in HSPM. comparison of child and parent satisfaction with restorations used by ART and Hall technique. Design: A randomized, controlled, crossover clinical study including thirty children.

Detailed Description
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Background and Aims: Despite the widespread prevalence of HSPM: there are no comparative studies yet between ART and Hall technique in the restoration of HSPM. there are no studies yet on the success of ART in the treatment of HSPM. Design: A randomized, controlled, crossover clinical study including thirty children Each child will apply both of ART and Hall technique to him.

Official Title
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Atraumatic Restoration Treatment Compared to the Hall Technique for Management Hypomineralization Second Primary Molars

Conditions
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Hypomineralization, Tooth

Intervention / Treatment
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* Combination Product: Hall technique
* Combination Product: ART


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Absolute positive, positive or negative behavior according to the Frankel Scale. Healthy, both physically and mentally. Do not take medications that interfere with the assessment of pain within 24 hours prior to treatment. A child with HSPM-affected primary second molars on the right and left side in one jaw. The HSPM affected teeth from 2-6 degree in Ghanim scale. Teeth with atypical carious lesions. Teeth with post-eruption destroyed The presence of a clear, intact dentinal bridge between the caries and pulp radially. Exclusion Criteria: Allergy to the substances used in restoration. Presence of general or developmental medical conditions. Teeth with pulpitis inflammation or apical lesion or non-restorable. Teeth closed to being replaced.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A randomized, controlled, crossover clinical study, comparison of ART and Hall Technique.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A (Hall Technique)<br>31 child will be treated by one performed metal crown using Hall technique on one of HSPM affected tooth. The correct size of SSC for tooth will be selected. Use the separating rubber if necessary. Dried the tooth and cemented the SSC by glass ionomer luting cement and used finger pressure to seat the crown and instructed the child to bite down on the SSC. Half of the total number of children will received performed metal crown at the first by divided them randomly to the two groups using the randomization table. | Combination Product: Hall technique<br>* The child will be placed to them SSC on one of their HSPM affected teeth. Pain during treatment will be assessed using the FLACC scale and satisfaction the child and parent will be evaluated using likert scale after the treatment immediately and after one month and evaluate the success restoration adapted from Innes et al. after 3_6_9_12 month.<br>* Other names: A;|
| Experimental: B (ART)<br>31 child will be treated by Bulk fill glass hybrid restorative system (Equia Forte HT®) using Atraumatic restoration treatment on one of HSPM affected tooth. Isolate the tooth by cotton rolls, remove the carious soft tissue using hand instrument excavators then condition the cavity with a polyacrylic acid solution 11.5% for 10 seconds. After washed and dried the cavity insert the GIC and protect it by Equia forte coat. Half of the total number of children will received ART at the first by divided them randomly to the two groups using the randomization table. | Combination Product: ART<br>* The child will be restored to them one of their HSPM affected teeth by GIC. Pain during treatment will be assessed using the FLACC scale and satisfaction the child and parent will be evaluated using likert scale after the treatment immediately and after one month and evaluate the success restoration adapted from Innes et al. after 3_6_9_12 month.<br>* Other names: B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental pain assessed by FLACC scale | Evaluated by outcome assessor using the faces, legs, activity, cry, consolability behavioral rating scale (FLACC scale) a behavioral pain assessment scale which has five criteria face, legs, activity, cry, consolability, which are each assigned a score of 0,1 or2. Total score of scale is summed in range 0 to10, where:0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain. | During the placement of the restoration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Satisfaction with the restoration assessed by the Likert scale | Self-assessment by the children using Likert scale which is a psychometric scale has five responses (very satisfied, satisfied, neutral, unsatisfied, very unsatisfied) | Immediately after the placement of the restoration | 
| Parent Satisfaction with the restoration assessed by the Likert scale | Self-assessment by the parent using Likert scale which is a psychometric scale has five responses (very satisfied, satisfied, neutral, unsatisfied, very unsatisfied) | Immediately after the placement of the restoration after asking the child | 
| Child Satisfaction with the restoration assessed by the Likert scale | Self-assessment by the children using Likert scale which is a psychometric scale has five responses (very satisfied, satisfied, neutral, unsatisfied, very unsatisfied) | After one month from treatment | 
| Parent Satisfaction with the restoration assessed by the Likert scale | Self-assessment by the parent using Likert scale which is a psychometric scale has a five responses (very satisfied, satisfied, neutral, unsatisfied, very unsatisfied) | After one month from treatment after asking the child | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ART, Hall technique, HSPM, Children, Restoration