- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04355000
Comparative Evaluation of Effectiveness of Hall Technique and Resin Modified Glass Ionomer Cement in Controlling Occlusoproximal Caries in Primary Molars in Children
Comparative Evaluation of Effectiveness of Hall Technique and Resin Modified Glass Ionomer Cement in Controlling Occlusoproximal Caries in Dentin of Primary Molars in Children : A Randomized Clinical Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Dental caries is one of the most common preventable diseases which is recognized as the primary cause of oral pain and tooth loss. WHO claimed that poor oral health may have a profound effect on general health as well as quality of life. Dental caries is not an infectious disease that needs to be "cured" by removing bacteria or, even less so, a particular bacterial species. Instead, dental caries can be managed behaviorally by controlling its causative factors-namely, the supply of fermentable carbohydrates and the presence and maturation of bacterial dental biofilms.
Resin modified Glass ionomer cement (RMGIC) has been used as a material for placement of dental restorations and is known to release fluoride which can help to remineralize carious lesion. RMGIC has excellent compressive and tensile strength compared to water based material, very less sensitive to moisture during initial setting time, excellent bonding with tooth, long working time with rapid set and early strength, have lower modulus of elasticity, twice flexible compared to water based glass ionomers. Chisini et al conducted a systematic review and showed 93.6% success rate of RMGIC, 91.2% for compomer, 79.3% for composite resin in primary teeth restoration.
The Hall Technique (HT) is a method for restoring children's carious primary molars uses a preformed stainless steel crown (SSC) cemented with no caries removal, tooth preparation, or local anaesthesia. Schwendicke F reported that HT showed high cost-effectiveness, dominating conventional restoration mainly because HT is clinically more successful and result in significantly fewer retreatments. The Hall Technique has been shown to be a durable (being likely to last the lifespan of the primary molar) and economical management option for primary molars with carious lesions, which in addition offers the benefit of full coronal coverage, reducing the risk of future carious lesion development.
The patients will be randomly allocated into two groups:
Group 1 - 45 Teeth will be treated using Hall Technique. Group 2 - 45 Teeth will be treated using resin modified glass ionomer cement(Vitremer).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Haryana
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Rohtak, Haryana, India, 124001
- Post Graduate Institute of Dental Sciences
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Hall Technique
In 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.
|
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.
|
Active Comparator: RMGIC restoration
In 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.
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Complete removal of caries and filling will be done with RMGIC material
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical success
Time Frame: Baseline to 12 months
|
Clinical success will be assessed by absence of clinical signs and symptoms
|
Baseline to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiographic success
Time Frame: Baseline to 12 months
|
Absence of periapical alterations (radiolucency at furcal or periapical region).
|
Baseline to 12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Saurabh@Pedo#PGIDS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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