ART Compared to the Hall Technique for Management HSPM

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypomineralization, Tooth
• Intervention / Treatment: Combination product: Hall technique; Combination product: ART

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.

• Study Type: Interventional
• Enrollment (Anticipated): 31
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nabih Raslan, Dr; Phone Number: 00963999140762; Email: Raslan.nabih@tishreen.edu.sy
• Study Contact Backup: Name: Aya Adl, Dr; Phone Number: 00963965334652; Email: Ayoosh.sy994@gmail.com

Study Locations

• Syrian Arab Republic
  • Latakia, Syrian Arab Republic
    • Recruiting
    • Tishreen University
    • Contact: Nabih Raslan, Dr; Phone Number: 00963999140762; Email: Raslan.nabih@tishreen.edu.sy
    • Contact: Aya Adl, Dr; Phone Number: 00963965334652; Email: Ayoosh.sy994@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A (Hall Technique); 31 child will be treated by one performed metal crown using Hall technique on one of HSPM affected tooth. The correct size of SSC for tooth will be selected. Use the separating rubber if necessary. Dried the tooth and cemented the SSC by glass ionomer luting cement and used finger pressure to seat the crown and instructed the child to bite down on the SSC. Half of the total number of children will received performed metal crown at the first by divided them randomly to the two groups using the randomization table.	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.; Other Names: A
Experimental: B (ART); 31 child will be treated by Bulk fill glass hybrid restorative system (Equia Forte HT®) using Atraumatic restoration treatment on one of HSPM affected tooth. Isolate the tooth by cotton rolls, remove the carious soft tissue using hand instrument excavators then condition the cavity with a polyacrylic acid solution 11.5% for 10 seconds. After washed and dried the cavity insert the GIC and protect it by Equia forte coat. Half of the total number of children will received ART at the first by divided them randomly to the two groups using the randomization table.	Combination product: 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.; Other Names: B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Tishreen University
• Investigators: Principal Investigator: Aya Adl, Dr, Tishreen University

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2023
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): April 30, 2024

Study Registration Dates

• First Submitted: March 28, 2023
• First Submitted That Met QC Criteria: April 13, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Children; ART; Restoration; Hall technique; HSPM
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization
• Other Study ID Numbers: Restoration for HSPM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Up to date, there is no decision about IPD sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No