Back to resultsART Compared to the Hall Technique for Management HSPM
Primary Purpose
Hypomineralization, Tooth
Status
Recruiting
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Hall technique
ART
Sponsored by
About this trial
This is an interventional treatment trial for Hypomineralization, Tooth focused on measuring ART, Hall technique, HSPM, Children, Restoration
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.
Sites / Locations
- Tishreen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
A (Hall Technique)
B (ART)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
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)
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)
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05816096
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 26, 2023 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tishreen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypomineralization, Tooth
Keywords
ART, Hall technique, HSPM, Children, Restoration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
A randomized, controlled, crossover clinical study, comparison of ART and Hall Technique.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A (Hall Technique)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
B (ART)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Hall technique
Other Intervention Name(s)
A
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
ART
Other Intervention Name(s)
B
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dental pain assessed by FLACC scale
Description
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.
Time Frame
During the placement of the restoration
Secondary Outcome Measure Information:
Title
Child Satisfaction with the restoration assessed by the Likert scale
Description
Self-assessment by the children using Likert scale which is a psychometric scale has five responses (very satisfied, satisfied, neutral, unsatisfied, very unsatisfied)
Time Frame
Immediately after the placement of the restoration
Title
Parent Satisfaction with the restoration assessed by the Likert scale
Description
Self-assessment by the parent using Likert scale which is a psychometric scale has five responses (very satisfied, satisfied, neutral, unsatisfied, very unsatisfied)
Time Frame
Immediately after the placement of the restoration after asking the child
Title
Child Satisfaction with the restoration assessed by the Likert scale
Description
Self-assessment by the children using Likert scale which is a psychometric scale has five responses (very satisfied, satisfied, neutral, unsatisfied, very unsatisfied)
Time Frame
After one month from treatment
Title
Parent Satisfaction with the restoration assessed by the Likert scale
Description
Self-assessment by the parent using Likert scale which is a psychometric scale has a five responses (very satisfied, satisfied, neutral, unsatisfied, very unsatisfied)
Time Frame
After one month from treatment after asking the child
Other Pre-specified Outcome Measures:
Title
Clinical success of restoration assessed by evaluation criteria for restoration assessments after 3 months
Description
Evaluated by outcome assessor using evaluation criteria for restoration assessments which has three scores (success, minor failures, major failures) for ART and Hall technique.
Time Frame
After 3 months from treatment
Title
Radiological success of restoration assessed by Radiological success cireteria after 6 months
Description
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.
Time Frame
After 6 months from traetment
Title
Clinical success of restoration assessed by evaluation criteria for restoration assessments after 6 months
Description
Evaluated by outcome assessor using evaluation criteria for restoration assessments which has three scores (success, minor failures, major failures) for ART and Hall technique.
Time Frame
After 6 months from treatment
Title
Clinical success of restoration assessed by evaluation criteria for restoration assessments after 9 months
Description
Evaluated by outcome assessor using evaluation criteria for restoration assessments which has three scores (success, minor failures, major failures) for ART and Hall technique.
Time Frame
After 9 months from treatment
Title
Clinical success of restoration assessed by evaluation criteria for restoration assessments after 12 months
Description
Evaluated by outcome assessor using evaluation criteria for restoration assessments which has three scores (success, minor failures, major failures) for ART and Hall technique.
Time Frame
After 12 months from treatment
Title
Radiological success of restoration assessed by Radiological success cireteria after 12 months
Description
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.
Time Frame
After 12 months from treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nabih Raslan, Dr
Phone
00963999140762
Email
Raslan.nabih@tishreen.edu.sy
First Name & Middle Initial & Last Name or Official Title & Degree
Aya Adl, Dr
Phone
00963965334652
Email
Ayoosh.sy994@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nabih Raslan, Dr
Organizational Affiliation
Tishreen University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Aya Adl, Dr
Organizational Affiliation
Tishreen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tishreen University
City
Latakia
Country
Syrian Arab Republic
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nabih Raslan, Dr
Phone
00963999140762
Email
Raslan.nabih@tishreen.edu.sy
First Name & Middle Initial & Last Name & Degree
Aya Adl, Dr
Phone
00963965334652
Email
Ayoosh.sy994@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Up to date, there is no decision about IPD sharing
Learn more about this trial
ART Compared to the Hall Technique for Management HSPM
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