An interventional study of Bioflx Crown Restoration (Group I) and Celluloid Strip Crown Restoration (Group II) in Clinical, Primary Teeth and Restoration, sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to participants aged 3 Years to 5 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Tanta University · Not applicable, Interventional, and Treatment
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.
forty pediatric patients aged 3 to 5 years presenting with bilateral multi-surface carious primary anterior teeth requiring full coronal restoration are enrolled. Each child receives a Bioflx crown on one target tooth (Group I) and a Celluloid strip crown on the contralateral target tooth (Group II). Clinical outcomes are systematically evaluated at 3, 6, and 9 months post-operative using Modified United States Public Health Service (USPHS) criteria (assessing marginal integrity, color match, restoration integrity/failure rate, and proximal contacts) along with Silness-Löe Plaque and Gingival Indices.
Tanta University is the lead sponsor of 987 studies on the registry; 313 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Carious primary anterior teeth prepared and restored using prefabricated translucent hybrid resin Bioflx pediatric crowns cemented with glass ionomer cement.
Procedure: Bioflx Crown Restoration (Group I)
Carious primary anterior teeth prepared, etched, bonded, and restored using resin composite filled inside Celluloid strip crown forms.
Procedure: Celluloid Strip Crown Restoration (Group II)
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.
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.
Cumulative Restoration Success Rate via Modified USPHS Criteria
Proportion of restored crowns categorized as clinically successful (expressed as a percentage). Restoration success is defined as achieving Alpha (A) or Bravo (B) ratings across all four Modified USPHS parameters evaluated via visual, explorer, and dental floss inspection: 1. Marginal Integrity (Alpha = smooth adaptation; Bravo = explorer catches); 2. Color Match (Alpha = exact match; Bravo = acceptable mismatch); 3. Restoration Integrity (Alpha = intact; Bravo = small material loss); 4. Proximal Contact (Alpha = normal resistance to floss; Bravo = contact present without resistance). A rating of Charlie (C) or Delta (D) in any single parameter constitutes restoration failure.
Time frame: Evaluated at 3, 6, and 9 months post-operative.
Gingival Health Response (Gingival Index)
Measure Description: Evaluation of marginal gingival tissue health surrounding each restored crown using the Löe and Silness Gingival Index (GI) scored from 0 to 3 (0 = Normal gingiva; 1 = Mild inflammation/slight edema; 2 = Moderate inflammation/erythema/bleeding on probing; 3 = Severe inflammation/spontaneous bleeding).
Time frame: Evaluated at baseline, 3, 6, and 9 months post-operative.
Plaque Index Score around Restored Teeth
Measure Description: Assessment of soft microbial plaque thickness at the gingival margin surrounding each crown using the Silness-Löe Plaque Index (PI) scored from 0 to 3 (0 = No plaque; 1 = Thin film at gingival margin; 2 = Moderate accumulation; 3 = Abundance of plaque).
Time frame: Evaluated at baseline, 3, 6, and 9 months post-operative.
Started Nov 2025 (actual). Primary completion is estimated for Nov 2026, 12 months after the start.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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