Evaluation of Bioflex Crowns Using the Hall Technique in Primary Molars (a Randomized Controlled Clinical Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alexandria University
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- To evaluate the clinical performance of BioFlex crowns versus SSCs using HT.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
statistician was blinded
Eligibility Criteria
- Ages
- 4 Years to 7 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •Pathologic mobility (identified by gently rocking the tooth buccolingually using tweezers).
Arms & Interventions
bioflex crown using hall technique
bioflex crown using the hall technique
Intervention: bioflex crown using hall technique (Other)
stainless steel crowns using hall technique
stainless steel crown using the hall technique
Intervention: stainless steel crown using hall technique (Other)
Outcomes
Primary Outcomes
To evaluate the clinical performance of BioFlex crowns versus SSCs using HT.
Time Frame: 12 months
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.
To evaluate the radiographic success of BioFlex crowns versus SSCs using HT.
Time Frame: 12 months
radiographic evaluation using digital xrays • Teeth will be considered radiographically successful if they show no evidence of: 1. Radicular radiolucency 2. Internal or external root resorption 3. Periodontal ligament space widening
Secondary Outcomes
- Temporomandibular joint function assessment(6 months)
- Changes in the occlusal vertical dimensions(1 month)
- Dental plaque assessment(12 months)
- gingival health assessment(12 months)
- Parental satisfaction assessment(12 months)
- child satisfaction assessment(immediately after treatment)
Investigators
Yousra Ramadan
assistant lecturer
Alexandria University