Bite Force Recovery Following Pediatric Full Crown Restorations
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-8
SponsorTanta University
About this trial
A component of masticatory function is bite force. Dental caries is one factor that contributes to poor dental health, which has an overall negative influence on quality of life. Caries has a detrimental after effect of functional impairment. this study aims to evaluate how children occlusal bite forces are affected by complete dental care. thirty children with dental caries in their primary molars, ages 5 to 8, of both sexes will be included. Occlusal force gauge was used to measure the occlusal bite force in the vicinity of primary molars both before and after restorations. A statistical analysis was performed on the collected data
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children aged 5-8 years.
Healthy and cooperative children who are able to tolerate the required dental procedures and follow-up visits.
Children requiring full-coverage crown restoration of a primary molar due to extensive or multisurface caries, wide proximal carious lesions
Primary molars requiring pulp therapy followed by full-coverage restoration.
Disqualifiers
Temporomandibular joint disorders
Apparent facial asymmetry.
Uncontrolled systemic disease or medical condition that may affect participation in the study or the dental treatment.
Current or previous orthodontic treatment that may influence occlusion or bite-force measurements.
Trial design
Design model
Parallel
Treatments tested in this trial
Preformed BioFlx Crown
Procedure/SurgeryEligible primary molars will be restored with appropriately sized BioFlx crowns following tooth preparation according to the manufacturer's recommendations. The crowns will be adjusted as needed, cemented using glass ionomer cement, and final occlusion will be verified.
Preformed Stainless Steel Crown
Procedure/SurgeryEligible primary molars will be prepared according to standard clinical procedures, fitted with an appropriately sized crown, adjusted and contoured as required, cemented using glass ionomer cement, and final occlusion will be verified.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: BioFlx Crown GroupExperimental treatment 1 intervention
Group B: Stainless Steel Crown GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Occlusal Bite Force Distribution
The percentage of total occlusal force (%) distributed on the restored primary molar will be measured using a digital occlusal analysis system. The closure demonstrating the maximum recorded occlusal force will be selected for analysis.
Time frame
Baseline (before crown placement), immediately after crown cementation, one and three months after treatment.Secondary outcomes
1
Masseter Muscle Activity
Bilateral masseter muscle activity, expressed as integrated mean electromyographic activity (µV or µV·s, according to the recording output), will be measured using surface electromyography (sEMG) during the rest position and maximum voluntary clenching.
Time frame
Baseline (before crown placement), immediately after crown cementation, one month and three months after treatment.2
Occlusal Contacts
The number and distribution of occlusal contacts, including the presence or absence of premature occlusal contacts (number of patients/teeth with premature contacts), will be assessed using digital intraoral scanning and digital occlusal analysis.
Time frame
Baseline, immediately after crown placement, and 1 and 3 month after treatment.Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
faculty of dentistry, Tanta university Status unavailable 31527, Tanta, Cairo Governorate
Egypt
EgyptSponsors and contacts
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Source ClinicalTrials.gov
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