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The Effect of Light Curable Resin Modified Glass Ionomer Varnish on Inhibiting the Progression of Non-Cavitated Proximal Carious Lesions: A Randomized Controlled Trial
The standard-of-care preventive measures to stop early tooth decay from becoming worse is by fluoride application, diet counseling, and oral hygiene instructions. This standard way is not always successful. The purpose of this study is to compare standard-of-care preventive measures to stop further tooth decay to standard-of-care preventive measures in addition to a light curable resin modified glass ionomer (RMGI) varnish material (Vanish XT). The material is used for root surface sensitivity treatment, site specific protective coating for newly erupted teeth and other tooth surfaces including early tooth decay. To be in this study the child must be five to eight years old, medically healthy, attending the Pediatric Dentistry Clinics in King Abdulaziz University Dental Hospital (KAUDH),diagnosed to have at least two primary molars and/ or first permanent molars with early-stage caries (using bitewing radiographs, near infrared digital imaging transilluminaton (NIDIT), and visual assessment), and willing to return for follow up visits. If the child is eligible and the parents agree to the participation of their child in this study, the researcher will review the child's personal and medical history. The child's two included molars diagnosed with early-stage caries will be randomly assigned to one of two groups: Control Group: will receive standard-of-care preventive measures. Test Group: will receive RMGI varnish application plus the standard-of-care preventive measures. The child will be followed up at six months and 12 months. A dental examination will be done using the same methods used in the first examination to determine whether the caries has become deeper or not. The child may be withdrawn from the study at this point if the caries has become too deep and the tooth will then need a filling. The child's medical status will be up-dated, reinforcement of oral hygiene instruction and diet counseling will be provided, and fluoride varnish application will be applied to all the teeth in both six and 12 months follow-ups.The RMGI varnish will be reapplied to the test teeth at the six months follow up.
Details
| Lead sponsor | King Abdulaziz University |
|---|---|
| Phase | NA |
| Status | UNKNOWN |
| Enrolment | 88 |
| Start date | 2018-01-11 |
| Completion | 2019-11 |
Conditions
- Dental Caries
- Dental White Spot
Interventions
- Light curable resin modified glass ionomer varnish
- standard-of-care preventive measures
Primary outcomes
- Clinical progression of non-cavitated proximal carious lesions measured using ICDAS six months after treatment — After six of treatment
To evaluate the clinical progression of non-cavitated proximal carious lesions in primary molars and first permanent molars measured using the ICDAS after treatment with light curable RMGI varnish in addition to standard-of-care preventive measures compared to standard-of-care preventive measures alone after six months. - Clinical progression of non-cavitated proximal carious lesions measured using ICDAS 12 months after treatment — After 12 months.
To evaluate the clinical progression of non-cavitated proximal carious lesions in primary molars and first permanent molars measured using the ICDAS after treatment with light curable RMGI varnish in addition to standard-of-care preventive measures compared to standard-of-care preventive measures alone after 12 months. - Radiographic progression of non-cavitated proximal carious lesions assessed using bitewing radiographs six months after treatment — After six months
To evaluate the radiographic progression of non-cavitated proximal carious lesions in primary molars and first permanent molars assessed by examination of bitewing radiographs after treatment with light curable RMGI varnish in addition to standard-of-care preventive measures compared to standard-of-care preventive measures alone after six months. - Radiographic progression of non-cavitated proximal carious lesions assessed using bitewing radiographs 12 months after treatment — After 12 months
To evaluate the radiographic progression of non-cavitated proximal carious lesions in primary molars and first permanent molars assessed by examination of bitewing radiographs after treatment with light curable RMGI varnish in addition to standard-of-care preventive measures compared to standard-of-care preventive measures alone after 12 months. - Progression of non-cavitated proximal carious lesions measured with NILT six months after treatment — After six months
To evaluate the progression of non-cavitated proximal carious lesions in primary molars and first permanent molars measured with NILT after treatment with light curable RMGI varnish in addition to standard-of-care preventive measures compared to standard-of-care preventive measures alone after six months. - Progression of non-cavitated proximal carious lesions measured with NILT 12 months after treatment — After 12 months
To evaluate the progression of non-cavitated proximal carious lesions in primary molars and first permanent molars measured with NILT after treatment with light curable RMGI varnish in addition to standard-of-care preventive measures compared to standard-of-care preventive measures alone after 12 months.
Countries
Saudi Arabia