Comparative Evaluation of Effectiveness of Hall Technique and Resin Modified Glass Ionomer Cement in Controlling Occlusoproximal Caries in Primary Molars in Children
1 other identifier
interventional
90
1 country
1
Brief Summary
•To investigate clinical and radiographic outcomes of Hall Technique and conventional restorative care using RMGIC in occulusoproximal carious lesions of primary molars in children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2019
CompletedFirst Submitted
Initial submission to the registry
April 17, 2020
CompletedFirst Posted
Study publicly available on registry
April 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedMay 14, 2020
April 1, 2020
1 year
April 17, 2020
May 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical success
Clinical success will be assessed by absence of clinical signs and symptoms
Baseline to 12 months
Secondary Outcomes (1)
Radiographic success
Baseline to 12 months
Study Arms (2)
Hall Technique
ACTIVE COMPARATORIn Hall Technique, SS Crown will be cemented on primary carious molar which satisfy the inclusion criterion without any carious removal, without any tooth preperation, without any local anaesthesia.
RMGIC restoration
ACTIVE COMPARATORIn RMGIC(Vitremer) filling, carious lesion will be completely removed from primary molars using air rotor and local anaesthesia according to need and filled with vitremer rmgic material.
Interventions
SS Crown will be cemented on primary carious molar which satisfy the inclusion criterion without any carious removal, without any tooth preperation, without any local anaesthesia.
Complete removal of caries and filling will be done with RMGIC material
Eligibility Criteria
You may qualify if:
- Children aged between 4 to 8 years.
- Occlusoproximal caries into dentin affecting one or more than one surface,
- Crown is restorable.
- Absence of clinical signs and symptoms
- More than half root remaining.
- No complicating medical history
- Child able to co-operate.
- Parent and child have consented.
- Patient ready for radiographs.
You may not qualify if:
- Signs or symptoms of irreversible pulpitis, or dental abscess/fistula.
- Radiographic signs of pulpal involvement, or periradicular pathology.
- Where there is no cooperation as there is a risk of crown aspiration or swallowing.
- Patients at risk of infective endocarditis; immunocompromised children.
- Parents/carers do not give written consent for treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Post Graduate Institute of Dental Sciences
Rohtak, Haryana, 124001, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2020
First Posted
April 21, 2020
Study Start
November 1, 2019
Primary Completion
November 1, 2020
Study Completion
November 1, 2020
Last Updated
May 14, 2020
Record last verified: 2020-04