CompletedNot Applicable

Comparative Evaluation of Clinical Success of BIOFLX Crowns and SSC in Primary Molars

India36 participantsStarted 2025-06-22

Plain-language summary

Although Stainless steel crowns (SSC) are the gold standard treatment modality for multi-surface carious lesion in paediatric patients, the quest for metal free, aesthetic restoration with comparable features that of SSC still continues. This research compares the clinical effectiveness of Bioflx crowns (Kids-e-dental)TM to the "gold standard" Stainless Steel crowns (Rainbow crowns)TM

Who can participate

Age range10 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * • At least two primary molars (contra-lateral or opposing side) needing full coverage restoration. * Consent of patient/legal guardian of the child * Cooperative behaviour based on Frankel behaviour rating 3 or 4 (positive or definitely positive) Exclusion Criteria: * • Parent not willing to give consent. * Child with special health care needs * Uncooperative child based on Frankel rating1or 2 (definitely negative or negative) * History of Ni-Cr allergy

What they're measuring

US Public Health Service (USPHS) modified criteria

Timeframe: 1st month, 3rd month, 6th month and 12 th month

Trial details

NCT IDNCT07465211

Sponsorsatish vishwanathaiah

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-09-25

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