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Clinical Trials/CTRI/2024/05/067463
CTRI/2024/05/067463Not yet recruitingPhase 3

Comparative Evaluation of Clinical Success Rate of Prefabricated Nano-Composite Crowns and Stainless Steel Crowns in Primary Molars: An Observational Study

Dr Ritika Tiwari1 site in 1 country42 target enrollmentStarted: June 1, 2024Last updated:

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Enrollment
42
Locations
1
Primary Endpoint
To check crown retention, marginal integrity, gingival health, wear and tear of crown and wear and tear of antagonist tooth seen in prefabricated nano-composite crowns.

Study Overview

Brief Summary

Prefabricated Nano-Composite Crowns are a novel advancement in the field of pediatric dentistry, as the need for newer aesthetic replacements emerge. They are bio-inert and bio-functional crowns made to perfectly mimic the morphology of primary teeth in form and function. Made from laser sintered and vitrified nano composites, they claim to require minimal tooth preparation according to the manufacturers.

This is a Randomized Control Trial, and the aim of this study is to compare the clinical success rate of Prefabricated Nano-Composite Crowns with conventional Stainless Steel Crowns in primary molars.

42 teeth requiring full coverage crowns as post endodontic restorations in participants in the age group of 4-9 years will be recruited in this study. These 42 teeth will be divided into two groups, that is, Prefabricated Nano-Composite Crown Group and Stainless Steel Crown Group. Both the groups will be clinically assessed for retention of the crown, it’s marginal integrity, gingival health around the crown and wear and tear of the crown and the antagonist tooth, 6 months after placement of the crown.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
4.00 Year(s) to 9.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 4–9-year-old children requiring post endodontic full coverage crowns on primary molars
  • Healthy children.

Exclusion Criteria

  • Children with any gingival and periodontal disease
  • Children with para-functional habits
  • Children with special needs and systemic diseases
  • Teeth with physiologic mobility
  • Teeth with inadequate crown structure
  • Teeth with missing antagonist tooth.

Outcomes

Primary Outcomes

To check crown retention, marginal integrity, gingival health, wear and tear of crown and wear and tear of antagonist tooth seen in prefabricated nano-composite crowns.

Time Frame: 6 months

Secondary Outcomes

  • To compare the aforementioned parameters to those of Stainless Steel crowns(6 months)

Investigators

Sponsor
Dr Ritika Tiwari
Sponsor Class
Other [Self funded]
Responsible Party
Principal Investigator
Principal Investigator

Dr Ritika Tiwari

Yenepoya Dental College

Study Sites (1)

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