Clinical Performance and Acceptance of Bioflx Crowns

NCT06677983 | Recruiting

• 1 other identifier: 02202409293266
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Treating pediatric patients with early childhood caries can be challenging. For clinicians, managing a young child while ensuring high-quality treatment is difficult. It is essential to have the best equipment and materials available. Today, aesthetics are crucial in managing decayed teeth, with zirconia crowns often preferred for their visual appeal, although they require substantial preparation. The newly developed Bioflx crown, combining stainless steel and zirconia properties, offers an alternative solution.

Conditions

Caries

Outcome Measures

Primary Outcomes (2)

• Change in clinical success

  The crowns were evaluated clinically according to the following criteria: 1. Length: the margin is at the gingival crest or is extended to the cemento-enamel junction. 2. Position: crown is not rotated. 3. Polish: no scratches or roughness. 4. Cement: no excess cement remains in the sulcus. If all criteria fulfilled the crown is considered acceptable clinically, if not it is considered unacceptable.

  baseline, 6 months, and 12 months

• parental satisfaction

  The questionnaire for assessing parental satisfaction includes four main categories for rating the aesthetic characteristics: size, shape, color, and stain. Responses will be recorded on a five-point Likert scale, ranging from 1 (not at all satisfied) to 5 (very satisfied).

  through study completion, an average of 6 months

Study Arms (2)

Bioflex

EXPERIMENTAL

Other: Bioflex Crowns

SSC

ACTIVE COMPARATOR

Other: Stainless steel crown

Interventions

Bioflex Crowns OTHER

A preformed crown of similar size will be selected. Tooth preparation will be done using a tapered diamond bur to reduce the occlusal surface, including the central groove, by 1-1.5 mm. The proximal surfaces will be prepared by approximately 0.5 mm to clear the contact area.

Bioflex

Stainless steel crown OTHER

An appropriately sized preformed stainless-steel crown will be selected. Tooth preparation will involve using a tapered bur ) to reduce the occlusal surface by 1 to 1.5 mm, with interproximal reduction made on the mesial and distal sides. The selected crown size will be checked, and a trial fit will be conducted prior to cementation. Crimping pliers will be used, and the crown will be cemented with Type 1 glass ionomer cement. Any excess cement will be removed, and proper occlusion will be verified.

SSC

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• A child with primary molars is indicated for full coverage.

You may not qualify if:

• Children with any systemic disease
• Clinical or radiographic signs/symptoms of irreversible pulpitis as abscess, fistula, spontaneous pain, mobility, furcation involvement, internal or external root resorption
• Children cooperation (1,2) according to Frankl scale
• Parents are unwilling to enroll their children in study

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Outpatient Clinic of Pediatric dentistry, Faculty of dentistry, pharos University, Egypt

Alexandria, Egypt

RECRUITING

Central Study Contacts

Rabab K ElGhandour, PhD

CONTACT

01222469150; rabab.elghandour@pua.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Dental Public Health and biostatistical consultanat

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 7, 2024
• Study Start: February 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: July 1, 2025
• Last Updated: November 7, 2024

Record last verified: 2024-11

Locations

EG (1)