ART Compared to the Hall Technique for Management HSPM

NCT05816096 | Unknown DMC

• 1 other identifier: Restoration for HSPM
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypomineralization, Tooth

Keywords

ART; Hall technique; HSPM; Children; Restoration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Child Satisfaction with the restoration assessed by the Likert scale

  Immediately after the placement of the restoration

• Parent Satisfaction with the restoration assessed by the Likert scale

  Immediately after the placement of the restoration after asking the child

• 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

Other Outcomes (6)

• Clinical success of restoration assessed by evaluation criteria for restoration assessments after 3 months

  After 3 months from treatment

• Radiological success of restoration assessed by Radiological success cireteria after 6 months

  After 6 months from traetment

• Clinical success of restoration assessed by evaluation criteria for restoration assessments after 6 months

  After 6 months from treatment

Study Arms (2)

A (Hall Technique)

ACTIVE COMPARATOR

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

B (ART)

EXPERIMENTAL

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

Interventions

Hall technique COMBINATION_PRODUCT

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.

Also known as: A

A (Hall Technique)

ART COMBINATION_PRODUCT

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.

Also known as: B

B (ART)

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tishreen University: lead

Study Sites (1)

Tishreen University

Latakia, Syria

RECRUITING

MeSH Terms

Conditions

Dental Enamel Hypomineralization

Condition Hierarchy (Ancestors)

Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Nabih Raslan, Dr

  Tishreen University

  STUDY CHAIR

• Aya Adl, Dr

  Tishreen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nabih Raslan, Dr

CONTACT

00963999140762; Raslan.nabih@tishreen.edu.sy

Aya Adl, Dr

CONTACT

00963965334652; Ayoosh.sy994@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 18, 2023
• Study Start: March 26, 2023
• Primary Completion: March 1, 2024
• Study Completion: April 30, 2024
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

SY (1)