faculty of dentistry, Tanta university
Tanta, Cairo Governorate, 31527, Egypt
NCT Number: NCT07786805
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
Trial opening soon.
Get Notified5 year–8 year
All sexes
Interventional
Not applicable
Tanta, Cairo Governorate, 31527, Egypt
This controlled, randomized clinical trial aims to compare the recovery of occlusal function following restoration of primary molars with preformed BioFlx crowns and stainless steel crowns in children aged 5-8 years. thirty eligible children requiring full-coverage crown restorations of primary molars will be randomly allocated to receive either a BioFlx crown or a stainless steel crown. Occlusal bite force, occlusal contact distribution, vertical dimension, and masseter muscle activity assessed by surface electromyography will be evaluated before treatment, immediately after crown placement, and during follow-up. Clinical evaluations will also be performed at 1and 3 months.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Eligible 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.
Eligible 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.
Time frame: Baseline (before crown placement), immediately after crown cementation, one and three months after treatment.
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 month and three months after treatment.
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, immediately after crown placement, and 1 and 3 month after treatment.
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.
Contact information is provided by the study sponsor or research team.
Tanta University
Other
Bite Force Recovery Following Pediatric Full Crown Restorations: A Comparative Study of Bioflx and Stainless-steel Crowns
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07295574
Bite Force, Carious Primary Molars
Cairo, Giza Governorate, Egypt
View Trial DetailsNCT07639112
Bite Force, Complete Dentures
Zagreb, City of Zagreb, Croatia
View Trial DetailsNCT07266701
Behavior, Bite Force
Malmö, Skåne County, Sweden
View Trial DetailsNCT06934317
Bite Force, Dental Pulp Diseases
Irbid, Jordan
View Trial Details