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Clinical Trials/CTRI/2024/02/063350
CTRI/2024/02/063350Not yet recruitingNot Applicable

Evaluation of clinical performance of carious primary molars restored with two bioactive restorative materials in 4-8 year old children

Dr Gontla Devi Saranya1 site in 1 country45 target enrollmentStarted: March 1, 2024Last updated:

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

Sponsor
Dr Gontla Devi Saranya
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Gontla Devi Saranya

Vishnu Dental Collage

Study Sites (1)

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