An interventional study of Preformed BioFlx Crown and Preformed Stainless Steel Crown in Bite Force, Stainless-steel Crown and Masseter Muscle, sponsored by Tanta University. Not yet recruiting at 1 site in Egypt. Open to participants aged 5 Years to 8 Years. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Tanta University · Not applicable, Interventional, and Treatment
Among 205 studies in Dental Caries with a site in Egypt — 47 open to participants now, 67 under way, 1 of them phase 3. Dental Caries · Egypt.
Among the 205 studies in Dental Caries with a site in Egypt, this one is the 128th largest by planned enrollment of the 179 interventional ones, is one of 12 that started in 2026, is one of 153 with no phase, reaches primary completion later than 47 of the 66 other live ones, and was the 200th registered.
1,171 studies on the registry are indexed under Dental Caries; 209 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 967 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →47 of the 205 studies in Dental Caries with a site in Egypt are open now, in 1 country. Each count lists the studies.
Of the 86 Dental Caries studies recruiting now, 18 (21%) set no upper age limit and 66 (77%) stop at 75 or younger; 60 take children under 18; 53 take healthy volunteers.
This study: 5 Years to 8 Years · all sexes · no healthy volunteers.
The full table on the hub →205 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 12 started in 2026.
Median enrollment 44 across the 179 interventional studies, 219 across the 26 observational. Of the 103 that completed or were terminated, 2 (2%) have results posted.
2 of 205 have an industry lead sponsor. The 10 most frequent:
Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Tanta University has 4 studies filed under Dental Caries — fewer than ten, so there is no comparison to draw.
19 of the studies in Dental Caries with a site in Egypt that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07786805Tanta UniversityBite Force Recovery Following Pediatric Full Crown Restorations | 2026-11 |
| NCT07003360Mansoura UniversityClinical Evaluation of Bioactive Restorative Materials | 2026-11-02 |
| NCT05943782Ain Shams UniversityEvaluation of CAD/CAM Onlays Fabricated by Subtractive Versus Additive Digital Manufacturing Techniques. | 2026-12-01 |
| NCT07612540Cairo UniversityRetention and Caries Prevention of Giomer Sealant With or Without Diode Laser Pre-treatment: A Randomized Controlled Trial | 2026-12-01 |
| NCT07262086Suez Canal UniversityClinical Evaluation of Wear Resistance and Bioactivity of Self Cured Bioactive Resin Composite | 2026-12-02 |
Among the 205 studies in Dental Caries with a site in Egypt, from their registry updates:
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
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants will receive preformed BioFlx full-coverage crowns for restoration of eligible primary molars.
Procedure: Preformed BioFlx Crown
Participants will receive preformed stainless steel full-coverage crowns for restoration of eligible primary molars.
Procedure: Preformed Stainless Steel Crown
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.
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.
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.
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.
Start is estimated for Sep 2026; primary completion for Nov 2026, 2 months later.
Of 469 non-industry interventional studies with no phase under Dental Caries, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 2 months is below that.
Counting every sponsor, half of 502 studies reached it within 15 months; a quarter within 7 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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