Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
31 participants
INTERVENTIONAL
2023-03-26
2024-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Major Failure Rate Assessment of Atraumatic Restorative Techniques Versus Hall Technique in the Management of Decayed Primary Molars in Children Aged 4-6 Years Old
NCT06589622
Hall Technique vs Conventional Crown Restoration in Permanent Molars: Split-Mouth Trial in Children
NCT07186673
Time of Treatment in HALL Technique Vs ART
NCT06594770
ART and Hall Technique for Management of Occlusal-proximal Caries in Primary Molars
NCT02569047
Evaluation Of Periodontal Health After Treatment With Hall Technique Versus Atraumatic Restorative Treatment in The Management of Carious Primary Molars
NCT06591143
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Presence of general or developmental medical conditions.
* Teeth with pulpitis inflammation or apical lesion or non-restorable.
* Teeth closed to being replaced.
3 Years
11 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tishreen University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nabih Raslan, Dr
Role: STUDY_CHAIR
Tishreen University
Aya Adl, Dr
Role: PRINCIPAL_INVESTIGATOR
Tishreen University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tishreen University
Latakia, , Syria
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Restoration for HSPM
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.