Atraumatic Restoration Treatment Compared to the Hall Technique for Management Hypomineralization Second Primary Molars
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Tishreen University
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Dental pain assessed by FLACC scale
Study Overview
Brief Summary
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
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to 11 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Dental pain assessed by FLACC scale
Time Frame: During the placement of the restoration
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.
Secondary Outcomes
- Child Satisfaction with the restoration assessed by the Likert scale(After one month from treatment)
- Parent Satisfaction with the restoration assessed by the Likert scale(After one month from treatment after asking the child)