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Clinical Trials/CTRI/2024/11/077418
CTRI/2024/11/077418CompletedNot Applicable

Comparative evaluation of Hybrid Resin Polymer, Nano Hybrid Composite and preformed Stainless-steel crowns in primary second molars- A Randomized Control Trial

Irin Mariam Zachariah1 site in 1 country45 target enrollmentStarted: December 10, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
45
Locations
1
Primary Endpoint
•To evaluate the gingival and periodontal health of tooth among hybrid resin polymer crown, nano hybrid composite crown and stainless-steel crown in mandibular primary second molars.

Study Overview

Brief Summary

The present study is to evaluate and compare clinical success of these full coverage restorations, hybrid resin polymer crown and nano hybrid composite crown with the gold standard stainless steel crown on mandibular primary second molars. the study concluded that Stainless steel crowns are considered as gold standard in pediatric crown because of its better clinical performance while Bioflx crowns and Edelweiss crowns can be considered as an alternative when esthetics is prime concern.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

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

Inclusion Criteria

  • Patients within age group of 5 – 9 years
  • Apparently healthy children free of any systemic disease or any developmental disturbances
  • Pulpotomized or pulpectomized primary mandibular second molars
  • Cooperative children.

Exclusion Criteria

  • Children having any parafunctional habits
  • Children allergic to nickel, resin polymer and nano hybrid composite.
  • Patients not willing to take part in the study.

Outcomes

Primary Outcomes

•To evaluate the gingival and periodontal health of tooth among hybrid resin polymer crown, nano hybrid composite crown and stainless-steel crown in mandibular primary second molars.

Time Frame: 2 YEARS

•To evaluate the retention of hybrid resin polymer crown, nano hybrid composite crown and stainless-steel crown in mandibular primary second molars

Time Frame: 2 YEARS

•To evaluate the attrition of crown/opposing tooth among hybrid resin polymer crown, nano hybrid composite crown and stainless-steel crown in mandibular primary second molars

Time Frame: 2 YEARS

•To compare the gingival and periodontal health of tooth, retention and attrition of crown/opposing tooth among hybrid resin polymer crown, nano hybrid composite crown and stainless-steel crown in mandibular primary second molars

Time Frame: 2 YEARS

Secondary Outcomes

  • •To evaluate the chair side time & patient & parent satisfaction of hybrid- resin- polymer crown, nano-hybrid-composite crown & stainless-steel crown in mandibular primary second molars.(•To compare the chair side time & patient & parent satisfaction of hybrid- resin- polymer crown, nano hybrid composite crown & stainless-steel crown in mandibular primary second molars)

Investigators

Sponsor
Irin Mariam Zachariah
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Irin Mariam Zachariah

PMS College of Dental Science and Research

Study Sites (1)

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