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Evaluation of Bioflex Crowns Using the Hall Technique in Primary Molars

NCT ID: NCT06847646

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-20

Study Completion Date

2025-08-20

Brief Summary

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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

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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.

Conditions

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BioFlex Crowns Using Hall Technique

Keywords

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BioFlex crowns SSCs Hall technique TMJ function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study was a two arm, parallel group, randomized controlled clinical trial. Allocation ratio is intended to be 1:1.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

statistician was blinded

Study Groups

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bioflex crown using hall technique

bioflex crown using the hall technique

Group Type EXPERIMENTAL

bioflex crown using hall technique

Intervention Type OTHER

crowns assessment

stainless steel crowns using hall technique

stainless steel crown using the hall technique

Group Type ACTIVE_COMPARATOR

stainless steel crown using hall technique

Intervention Type OTHER

crown assessment

Interventions

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bioflex crown using hall technique

crowns assessment

Intervention Type OTHER

stainless steel crown using hall technique

crown assessment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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).
Minimum Eligible Age

4 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Yousra Ramadan

assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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yousra ramadan, Ms

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Locations

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Faculty of Dentistry Alexandria University

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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0931-06/2024

Identifier Type: -

Identifier Source: org_study_id