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ART Compared to the Hall Technique for Management HSPM

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05816096
Enrollment
31
Registered
2023-04-18
Start date
2023-03-26
Completion date
2024-04-30
Last updated
2023-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypomineralization, Tooth

Keywords

ART, Hall technique, HSPM, Children, Restoration

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: A randomized, controlled, crossover clinical study including thirty children Each child will apply both of ART and Hall technique to him.

Interventions

COMBINATION_PRODUCTHall 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.

COMBINATION_PRODUCTART

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.

Sponsors

Tishreen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

A randomized, controlled, crossover clinical study, comparison of ART and Hall Technique.

Eligibility

Sex/Gender
ALL
Age
3 Years to 11 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Dental pain assessed by FLACC scaleDuring the placement of the restorationEvaluated 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

MeasureTime frameDescription
Child Satisfaction with the restoration assessed by the Likert scaleImmediately after the placement of the restorationSelf-assessment by the children using Likert scale which is a psychometric scale has five responses (very satisfied, satisfied, neutral, unsatisfied, very unsatisfied)
Parent Satisfaction with the restoration assessed by the Likert scaleImmediately after the placement of the restoration after asking the childSelf-assessment by the parent using Likert scale which is a psychometric scale has five responses (very satisfied, satisfied, neutral, unsatisfied, very unsatisfied)

Other

MeasureTime frameDescription
Clinical success of restoration assessed by evaluation criteria for restoration assessments after 9 monthsAfter 9 months from treatmentEvaluated by outcome assessor using evaluation criteria for restoration assessments which has three scores (success, minor failures, major failures) for ART and Hall technique.
Clinical success of restoration assessed by evaluation criteria for restoration assessments after 3 monthsAfter 3 months from treatmentEvaluated by outcome assessor using evaluation criteria for restoration assessments which has three scores (success, minor failures, major failures) for ART and Hall technique.
Radiological success of restoration assessed by Radiological success cireteria after 12 monthsAfter 12 months from treatmentEvaluated by outcome assessor using Radiological success cireteria for restoration. where the case is considered successful radiologically when all signs of pulpal necrosis are absent.
Clinical success of restoration assessed by evaluation criteria for restoration assessments after 12 monthsAfter 12 months from treatmentEvaluated by outcome assessor using evaluation criteria for restoration assessments which has three scores (success, minor failures, major failures) for ART and Hall technique.
Radiological success of restoration assessed by Radiological success cireteria after 6 monthsAfter 6 months from traetmentEvaluated by outcome assessor using Radiological success cireteria for restoration. where the case is considered successful radiologically when all signs of pulpal necrosis are absent.
Clinical success of restoration assessed by evaluation criteria for restoration assessments after 6 monthsAfter 6 months from treatmentEvaluated by outcome assessor using evaluation criteria for restoration assessments which has three scores (success, minor failures, major failures) for ART and Hall technique.

Countries

Syria

Contacts

Primary ContactNabih Raslan, Dr
Raslan.nabih@tishreen.edu.sy00963999140762
Backup ContactAya Adl, Dr
Ayoosh.sy994@gmail.com00963965334652

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026