- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02849925
Sealing Microcavitated Carious Lesions (SealCaries)
Randomized Controlled Clinical Trial on the Treatment of Caries Lesions Using Resin or Glass Ionomer Sealants in Permanent Teeth
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background and problem statement. Traditionally, caries treatment has been based on restorative procedures performed by dentist using dental biomaterials. Besides its high cost, this canonical approach for caries therapy has very limited coverage and only a small proportion of the population can satisfy the high demand. The latter is especially critical in developing countries. Available evidence has shown that some caries lesions, either cavitated or non-cavitated, may be treated by the placement of sealants. This minimally invasive treatment is more cost-effective than the restorative approach and it allows better coverage. Sealants placed on the active lesions hamper lesion progression, most likely by inhibiting nutrient uptake of the invading associated microbiota. The most commonly used material in clinical practice is resin sealant. Despite its advantages and simplicity of use, this material is highly sensitive to contamination by saliva or other ubiquitous oral fluids. Furthermore, adhesion to enamel is compromised when this tissue is immature. This pitfall of the technique is particularly crucial when it comes to treating lesions in erupting molars in children. Hence, glass ionomer cement (GI) sealants emerge as a potential alternative to resin sealants. GI sealants are more suitable to be used under non-ideal clinical conditions, such as in the presence of humidity or on lesions of immature erupting molars. Although there exists vast evidence on the use of sealants as preventive agents, studies dealing with this biomaterial as a therapeutic agent for caries lesions are more limited and scarce. In regard to the material, only few clinical studies with unclear conclusions are available. This proposal, therefore, will seek to compare progression of caries lesions treated with either resin or GI sealants, in occlusal cavitated lesions (Code 3, ICDAS) of permanent molars of 6 to 12 year-old children.
Methodology. A randomized controlled clinical trial (RCT) is proposed. Once approved by the Bioethics Committee and after obtaining a signed informed consent from their parents, volunteer children will be invited to participate. Two hundred caries lesions (Code 3, ICDAS) will be randomized to one of the two arms of the study, resin or GI sealants. The materials chosen to conduct the study would be Concise and Ketac Molar, respectively, both from 3M, St. Paul, MN. Sample size was estimated using a 95% significance level. Based on the caries prevalence of the population and studies performed by the investigators, the number of volunteers was estimated to be about one hundred volunteers to gather the required two hundred lesions. Three evaluations will be conducted every six months until completion of eighteen month of follow-up. All the exams and controls will be performed at the Dental Clinics of the University of Talca by one trained and calibrated examiner. Sealants will be placed following manufacturer's instructions. Participants will be randomly allocated to either study arm, regardless of the clinical indication, so selection bias will be avoided. Material retention and lesion progression will be the primary end-point at each control. Likewise, caries incidence in untreated teeth will be a secondary outcome of the study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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No State
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Talca, No State, Chile, 3460000
- Faculty of Health Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- To have at least one ICDAS 3 lesion in first permanent molars
- To be systemically healthy
Exclusion Criteria:
- Not fully erupted first molars
- Structural defects in first molars, i.e., hypoplasia, fluorosis, MIH.
- Periodontal disease
- Orthodontic appliances
- Medication use
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Glass Ionomer Sealant
Sealants to arrest microcavitated caries.
75 microcavitated ICDAS 3 lesions will be sealed by the use of Glass ionomer sealant, EQUIA (GC) in first permanent molars.
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Carious lesions will be treated by minimally invasive dentistry by the use of sealants instead of eliminating carious tissues and using conventional restorative materials.
Other Names:
|
Active Comparator: Resin Sealant
Sealants to arrest microcavitated caries.
75 microcavitated ICDAS 3 lesions will be sealed by the use of resin sealant, Clinpro (3M-ESPE) in first permanent molars
|
Carious lesions will be treated by minimally invasive dentistry by the use of sealants instead of eliminating carious tissues and using conventional restorative materials.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of lesions that evidence progression by a higher ICDAS code. The score will be expressed as percentage of progression among all the treated lesions.
Time Frame: 24 months
|
ICDAS 3 lesions will be followed and monitored for clinical and radiographic progression
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of sealants that were intact from the first intervention over time.
Time Frame: 24 months
|
Sealants used will be monitored for integrity and retention
|
24 months
|
Percentage of sealants that were fractured or lost during the follow-up.
Time Frame: 24 months
|
Sealants used will be monitored for integrity and retention
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24 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RCTICDAS3/2015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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