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Clinical trial

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

ID
Name
Restoration for HSPM
Description
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.
Trial arms
Trial start
2023-03-26
Estimated PCD
2024-03-01
Trial end
2024-04-30
Status
Recruiting
Treatment
Hall technique
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.
Arms:
A (Hall Technique)
Other names:
A
ART
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.
Arms:
B (ART)
Other names:
B
Size
31
Primary endpoint
Dental pain assessed by FLACC scale
During the placement of the restoration
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'A randomized, controlled, crossover clinical study, comparison of ART and Hall Technique.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 31, 'type': 'ESTIMATED'}}
Updated at
2023-04-18

1 organization

2 products

2 indications

Organization
Tishreen University
Product
Hall
Indication
Dental Hypomineralization
Indication
Dental Caries
Product
ART