Clinical Evaluation of Bioflx Crowns in Restoring Primary Anterior Teeth

Condition(s) studied

Investigational drug(s) / intervention(s)

Bioflx Crown Restoration (Group I): Preparation: Administration of 2% lidocaine local anesthesia with epinephrine; caries removal; 1-1.5 mm incisal reduction; 1 mm mesial/distal contact breaking using diamond burs; minimal labial/palatal reduction; rounding of sharp line angles. Seating \& Cementation: Selection of appropriate Bioflx crown size via mesiodistal caliper measurement; crown try-in; cavity sealing and final cementation using self-curing glass ionomer cement (IMICRYL Nova); excess cement removal with explorer and dental floss.

Celluloid Strip Crown Restoration (Group II): Preparation: Local anesthesia administration; caries removal; shade selection; incisal and proximal reduction. Matrix \& Bonding: Celluloid strip crown form selected, trimmed to length, verified for cervical adaptation, and vented at the incisal edge. Enamel etched with 37% phosphoric acid (CharmEtch) for 15 seconds, rinsed, and dried. Universal bonding agent (All-Bond Universal) applied and light-cured for 15 seconds. Placement \& Finishing: Crown form filled with shade-matched composite resin (Beautifil), seated firmly on the tooth, excess material removed, and light-cured. Celluloid form stripped off using an excavator; final polishing performed.

Study summary

This randomized controlled clinical trial evaluates and compares the clinical success and performance of prefabricated Bioflx crowns versus conventional Celluloid strip crowns in the restoration of badly decayed or traumatized primary anterior teeth.

Eligibility

Primary outcome measure(s)

• Restoration Clinical Performance (Modified USPHS Criteria) — Evaluated at 3, 6, and 9 months post-operative.
  Measure Description: Visual, explorer, and dental floss evaluation of four distinct clinical parameters scored as Alpha (A), Bravo (B), Charlie (C), or Delta (D): Marginal Integrity: Alpha (close adaptation), Bravo (explorer catches), Charlie (defect extending to dentin). Color Match: Alpha (exact match in shade/translucency), Bravo (mismatch within normal tooth range), Charlie (mismatch outside normal range). Restoration Integrity / Failure Rate: Alpha (normal, no chip/fracture), Bravo (small material loss), Charlie (large material loss), Delta (complete crown loss). Proximal Contact: Alpha (resistance to floss), Bravo (floss passes without resistance), Charlie (no contact).

Trial sites (1)

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