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
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
74
crowns assessment
crown assessment
Faculty of Dentistry Alexandria University
Alexandria, Egypt
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.
Time frame: 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: 1. Radicular radiolucency 2. Internal or external root resorption 3. Periodontal ligament space widening
Time frame: 12 months
Temporomandibular joint function assessment
The Helkimo Clinical Dysfunction Index (modified version) assesses TMJ dysfunction based on: Maximum Opening: 0 = ≥35 mm 1. = 25-34 mm 2. = \<25 mm Deflection During Opening: 0 = \<2 mm 1. = 2-5 mm 2. = \>5 mm Impaired TMJ Function: 0 = no impairment 1. = palpable click 2. = audible click, deadlock, or luxation Pain in TMJ: 0 = no pain 1. = palpable pain 2. = reflex pain Muscle Pain (Temporalis \& Masseter): 0 = no pain 1. = palpable pain 2. = 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.
Time frame: 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
Time frame: 1 month
Dental plaque assessment
Criteria for scoring plaque index (Silness and Löe) 0 No plaque 1. 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. 2. Moderate accumulation of soft deposits within the gingival pockets or the tooth and gingival margin which can be seen with the naked eye. 3. Abundance of soft matter within the gingival pocket and /or on the tooth and gingival margin.
Time frame: 12 months
gingival health assessment
Criteria for scoring gingival index (Löe and Silness) 0 Healthy (No gingivitis.). 1. Mild gingivitis, Slight redness and edema, no bleeding upon probing 2. Moderate gingivitis, moderate redness and edema, bleeding upon probing 3. Severe gingivitis, severe redness and edema, spontaneous bleeding and ulcerations
Time frame: 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.
Time frame: 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 1. Very happy. 2. Happy. 3. Neutral. 4. Sad. 5. Very sad.
Time frame: immediately after treatment
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