ART Compared to the Hall Technique for Management HSPM

Hypomineralization, Tooth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05816096
• Other study ID #: Restoration for HSPM
• Status: Recruiting
• Phase: N/A
• Start date: March 26, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: April 2023
• Source: Tishreen University
• Contact: Nabih Raslan, Dr
• Phone: 00963999140762
• Email: Raslan.nabih[@]tishreen.edu.sy
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 31
• Est. completion date: April 30, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypomineralization, Tooth
• Tooth Demineralization

Intervention

Combination Product:
• 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.
• 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.

Locations

Country	Name	City	State
Syrian Arab Republic	Tishreen University	Latakia

Sponsors (1)

Lead Sponsor	Collaborator
Tishreen University

Country where clinical trial is conducted

Syrian Arab Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical success of restoration assessed by evaluation criteria for restoration assessments after 3 months	Evaluated by outcome assessor using evaluation criteria for restoration assessments which has three scores (success, minor failures, major failures) for ART and Hall technique.	After 3 months from treatment
Other	Radiological success of restoration assessed by Radiological success cireteria after 6 months	Evaluated by outcome assessor using Radiological success cireteria for restoration.; where the case is considered successful radiologically when all signs of pulpal necrosis are absent.	After 6 months from traetment
Other	Clinical success of restoration assessed by evaluation criteria for restoration assessments after 6 months	Evaluated by outcome assessor using evaluation criteria for restoration assessments which has three scores (success, minor failures, major failures) for ART and Hall technique.	After 6 months from treatment
Other	Clinical success of restoration assessed by evaluation criteria for restoration assessments after 9 months	Evaluated by outcome assessor using evaluation criteria for restoration assessments which has three scores (success, minor failures, major failures) for ART and Hall technique.	After 9 months from treatment
Other	Clinical success of restoration assessed by evaluation criteria for restoration assessments after 12 months	Evaluated by outcome assessor using evaluation criteria for restoration assessments which has three scores (success, minor failures, major failures) for ART and Hall technique.	After 12 months from treatment
Other	Radiological success of restoration assessed by Radiological success cireteria after 12 months	Evaluated by outcome assessor using Radiological success cireteria for restoration.; where the case is considered successful radiologically when all signs of pulpal necrosis are absent.	After 12 months from treatment
Primary	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	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
Secondary	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
Secondary	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
Secondary	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