Evaluation of Bioflex Crowns Using the Hall Technique in Primary Molars

Alexandria University

Status: Completed

Conditions: BioFlex Crowns Using Hall Technique

Treatments: Other: stainless steel crown using hall technique; Other: bioflex crown using hall technique

Study type: Interventional

Funder types: Other

Identifiers

NCT06847646

0931-06/2024

Details and patient eligibility

About

The goal of this randomized controlled clinical trial is to to evaluate the clinical performance and radiographic success of BioFlex crowns versus SSCs using Hall Technique in primary dentition. The main questions it aims to answer are:

Does bioflex crowns have the same clinical performance and radiographic success of stainless steel crowns when placed using Hall Technique?

will bioflex crowns alter the occlusal vertical dimensions or affect the tempomandibular joint?

If there is a comparison group: Researchers will compare bioflex crown to stainless steel crown to see of the bioflex crowns are effective as stainless steel crowns when placed using hall technique

Participants will recieve bioflex crown and stainless steel crown according to randomization and they will be followed up immediately after treatment, after 2 weeks , after 1 months , after 3 months , after 6 months and after 12 months

Full description

The study will be a double-armed randomized controlled clinical trial, with parallel design. A total of 74 pediatric patients aged 4-8 years will be selected from the Pediatric Dentistry Outpatient Clinic, Faculty of Dentistry, Alexandria University, Egypt. Participants will be allocated into 2 groups according to the type of crown used. Group I (study group) will be treated with BioFlex crowns using Hall technique, while Group II (control group) will be treated with the SSCs using Hall technique. Clinical and radiographic success of both crowns will be assessed. The function of the temporomandibular joint (TMJ) will be evaluated using the Helkimo Clinical Dysfunction Index (Di) and the AAPD questionnaire. The Occlusovertical dimension measurements will also be evaluated using the Van der Zee and Van Amerongen method. Plaque and gingival health will be recorded using plaque and gingival indices, and the satisfaction level of the child will be assessed using the Facial Image Scale (FIS), while the satisfaction level of parents will be assessed using questionnaire.

Enrollment: 74 patients

Sex: All

Ages: 4 to 7 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

- Primary molar teeth with occlusal or occlusoproximal carious lesions into dentin (ICDAS codes: 3-5).

Exclusion Criteria: Teeth will be excluded if they exhibit:

• Clinical or radiographic signs of irreversible pulpitis.
• Presence of fistula or abscess.
• Spontaneous pain.
• Pulp exposure.
• Bruxism.
• Pathologic mobility (identified by gently rocking the tooth buccolingually using tweezers).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

bioflex crown using hall technique

Experimental group

Description:

bioflex crown using the hall technique

Treatment:

Other: bioflex crown using hall technique

stainless steel crowns using hall technique

Active Comparator group

Description:

stainless steel crown using the hall technique

Treatment:

Other: stainless steel crown using hall technique