Evaluation of Bioflex Crowns Using the Hall Technique in Primary Molars

Evaluation of Bioflex Crowns Using the Hall Technique in Primary Molars (a Randomized Controlled Clinical Trial)

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

Study Overview

• Status: Completed
• Conditions: BioFlex Crowns Using Hall Technique
• Intervention / Treatment: Other: bioflex crown using hall technique; Other: stainless steel crown using hall technique

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.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Faculty of dentistry Alexandria university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: bioflex crown using hall technique; bioflex crown using the hall technique	Other: bioflex crown using hall technique; crowns assessment
Active Comparator: stainless steel crowns using hall technique; stainless steel crown using the hall technique	Other: stainless steel crown using hall technique; crown assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the clinical performance of BioFlex crowns versus SSCs using HT.	clinical evaluation of crown performance Success: Satisfactory restoration/crown, no intervention required; No clinical signs or symptoms of pulp pathology Minor Failures: Crown presents perforation; Crown loss - tooth able to be re-treated Major Failures: • Reversible or irreversible pulpitis or dental fistula/abscess, requiring pulpotomy, pulpectomy or extraction.	12 months
To evaluate the radiographic success of BioFlex crowns versus SSCs using HT.	radiographic evaluation using digital xrays • Teeth will be considered radiographically successful if they show no evidence of: Radicular radiolucency; Internal or external root resorption; Periodontal ligament space widening	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temporomandibular joint function assessment	The Helkimo Clinical Dysfunction Index (modified version) assesses TMJ dysfunction based on: Maximum Opening: 0 = ≥35 mm; = 25-34 mm; = <25 mm Deflection During Opening: 0 = <2 mm; = 2-5 mm; = >5 mm Impaired TMJ Function: 0 = no impairment; = palpable click; = audible click, deadlock, or luxation Pain in TMJ: 0 = no pain; = palpable pain; = reflex pain Muscle Pain (Temporalis & Masseter): 0 = no pain; = palpable pain; = reflex pain Score Classification: 0 = no dysfunction 1-4 = mild dysfunction 5-9 = moderate dysfunction 9 = serious dysfunction The AAPD guidelines are used for assessing TMJ symptoms, asking about difficulty opening the mouth, pain, muscle pain in the temporalis and masseter, sounds, and jaw-related injuries. Responses are yes/no.	6 months
Changes in the occlusal vertical dimensions	The assessment of the OVD will be performed according to a Modified version of van der Zee and van Amerongen method The cusp tip of the left maxillary canine was marked using a pencil on the lower canine in the maximum intercuspation, and its distance to the mandibular canine cusp tip was measured using a UNC-15 probe and used as the overbite score	1 month
Dental plaque assessment	Criteria for scoring plaque index (Silness and Löe) 0 No plaque; A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface.; Moderate accumulation of soft deposits within the gingival pockets or the tooth and gingival margin which can be seen with the naked eye.; Abundance of soft matter within the gingival pocket and /or on the tooth and gingival margin.	12 months
gingival health assessment	Criteria for scoring gingival index (Löe and Silness) 0 Healthy (No gingivitis.).; Mild gingivitis, Slight redness and edema, no bleeding upon probing; Moderate gingivitis, moderate redness and edema, bleeding upon probing; Severe gingivitis, severe redness and edema, spontaneous bleeding and ulcerations	12 months
Parental satisfaction assessment	• The satisfaction level of parent/legal guardian will be assessed as performed immediately post-operative, in addition to problems that the child might be facing, such as bleeding around the crown, sensitivity, and food lodgment using questionnaire Parental satisfaction will be assessed on a Likert type scale from 1 to 5 using the seven following variables: shade, size, shape, retention, durability, overall satisfaction, and child's satisfaction.	12 months
child satisfaction assessment	• The patient's perception of the treatment will be assessed by using the Facial Image Scale (FIS) modified from the Maunuksela et al scale; Very happy.; Happy.; Neutral.; Sad.; Very sad.	immediately after treatment

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: yousra ramadan, Ms, Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2024
• Primary Completion (Actual): August 20, 2025
• Study Completion (Actual): August 20, 2025

Study Registration Dates

• First Submitted: February 19, 2025
• First Submitted That Met QC Criteria: February 21, 2025
• First Posted (Actual): February 26, 2025

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: TMJ function; Hall technique; BioFlex crowns; SSCs
• Other Study ID Numbers: 0931-06/2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No