Clinical trial NCT05816096: ART Compared to the Hall Technique for Management HSPM
Official title: Atraumatic Restoration Treatment Compared to the Hall Technique for Management Hypomineralization Second Primary Molars
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypomineralization, Tooth
Keywords: ART
Hall technique
HSPM
Children
Restoration
Lead sponsor: Tishreen University
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 31
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A randomized, controlled, crossover clinical study, comparison of ART and Hall Technique.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Dental pain assessed by FLACC scale
timeFrame: During the placement of the restoration
Secondary outcomes:
measure: Child Satisfaction with the restoration assessed by the Likert scale
timeFrame: Immediately after the placement of the restoration
measure: Parent Satisfaction with the restoration assessed by the Likert scale
timeFrame: Immediately after the placement of the restoration after asking the child
measure: Child Satisfaction with the restoration assessed by the Likert scale
timeFrame: After one month from treatment
measure: Parent Satisfaction with the restoration assessed by the Likert scale
timeFrame: After one month from treatment after asking the child
Other outcomes:
measure: Clinical success of restoration assessed by evaluation criteria for restoration assessments after 3 months
timeFrame: After 3 months from treatment
measure: Radiological success of restoration assessed by Radiological success cireteria after 6 months
timeFrame: After 6 months from traetment
measure: Clinical success of restoration assessed by evaluation criteria for restoration assessments after 6 months
timeFrame: After 6 months from treatment
measure: Clinical success of restoration assessed by evaluation criteria for restoration assessments after 9 months
timeFrame: After 9 months from treatment
measure: Clinical success of restoration assessed by evaluation criteria for restoration assessments after 12 months
timeFrame: After 12 months from treatment
measure: Radiological success of restoration assessed by Radiological success cireteria after 12 months
timeFrame: After 12 months from treatment
Locations:
city: Latakia
country: Syrian Arab Republic
facility: Tishreen University
Study officials:
affiliation: Tishreen University
name: Nabih Raslan, Dr
role: STUDY_CHAIR
affiliation: Tishreen University
name: Aya Adl, Dr
role: PRINCIPAL_INVESTIGATOR
References: