Clinical trial NCT06847646: Evaluation of Bioflex Crowns Using the Hall Technique in Primary Molars
Official title: Evaluation of Bioflex Crowns Using the Hall Technique in Primary Molars (a Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: BioFlex Crowns Using Hall Technique
Keywords: BioFlex crowns
SSCs
Hall technique
TMJ function
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 74
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was a two arm, parallel group, randomized controlled clinical trial. Allocation ratio is intended to be 1:1.
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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.

Eligibility 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).

Primary outcomes:
measure: To evaluate the clinical performance of BioFlex crowns versus SSCs using HT.
timeFrame: 12 months
measure: To evaluate the radiographic success of BioFlex crowns versus SSCs using HT.
timeFrame: 12 months
Secondary outcomes:
measure: Temporomandibular joint function assessment
timeFrame: 6 months
measure: Changes in the occlusal vertical dimensions
timeFrame: 1 month
measure: Dental plaque assessment
timeFrame: 12 months
measure: gingival health assessment
timeFrame: 12 months
measure: Parental satisfaction assessment
timeFrame: 12 months
measure: child satisfaction assessment
timeFrame: immediately after treatment
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry Alexandria University
Study officials:
affiliation: Alexandria University
name: yousra ramadan, Ms
role: PRINCIPAL_INVESTIGATOR
References: