Evaluation of clinical performance of carious primary molars restored with two bioactive restorative materials in 4-8 year old children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Marginal adaptation, Surface roughness, Secondary caries and Marginal staining
Study Overview
Brief Summary
Dental composites have been traditionally used aesthetic restorative materials. However secondary caries beneath and around the restorative materials is the most common cause of failure of composite resin restorations. The majority of the available composite resins have no remineralizing effect.In order to overcome these disadvantages of composite resins, there is a increasing tendency to use resin based bioactive and remineralizing restorative materials to increase the durability of bonded restorations. In restorative dentistry, the term bioactive usually refers to the ability of a material to form hydroxyapatite crystals on its surface. Bioactive materials are moisture friendly and imitate nature and participate in dynamic ionic exchange. Release of different remineralizing ions from the restorative materials into oral cavity and at the tooth restoration interface improves the longevity of restoration and decreases the rate of recurrent caries. Screening of 4-8 year old patients attending the outpatient department will be done. Details of the study will be explained to the patients and parents, with written informed consent obtained.Considering inclusion and exclusion criteria, children with bilateral occlusal caries will be included and random allocation in to two groups will be done with split mouth design. Group 1 will be restored with cention n and group 2 will be restored with active bioactive restorative materials. Post operative occlusal evaluation will be done using articulating paper and final adjustments will be done if required with finishing burs. Follow-up will be done at 6 and 12 months intervals and marginal adaptation, surface roughness, secondary caries and marginal staining will be evaluated using modified USPHS criteria. Statistical analysis will be done using non parametric tests, inter groupe comparison will be done using Mann Whitney ‘’ U’’ test and intragroup comparison will be done at 6 and 12 months intervals using Wilcoxon sign rank test .
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 4.00 Year(s) to 8.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Primary molars with bilateral occlusal caries in
- •4-8 year old children(ICDAS score 4/5 )
- •Co-operative children.
Exclusion Criteria
- •Medically compromised patients.
- •Teeth with developmental defects.
- •Teeth that are un-restorable
- •Teeth with signs and symptoms of pain or swelling.
Outcomes
Primary Outcomes
Marginal adaptation, Surface roughness, Secondary caries and Marginal staining
Time Frame: At 6 and 12 months after the restoration is done
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Gontla Devi Saranya
Vishnu Dental Collage
