Bite ForceNCT07825103
Postoperative Bite Force After Bioflx and Zirconia Crowns in Children
A study testing Preformed Bioflx Crown and Preformed Zirconia Crown in people with Bite Force and Masseter Muscle, run by Tanta University at 1 site in Egypt.
Trial summary
This randomized clinical trial aims to compare postoperative bite force following full-crown restoration with preformed Bioflx and zirconia crowns in children undergoing comprehensive dental treatment under general anesthesia. Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Bite Force, Masseter Muscle, Zirconia Crowns
- What is being tested?
- Preformed Bioflx Crown and Preformed Zirconia Crown
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 4-7 years.
- Children requiring comprehensive dental treatment under general anesthesia.
- Children requiring full-coverage restoration of one or more primary molars with a preformed pediatric crown.
- Primary molars with sufficient remaining tooth structure to support full-crown restoration.
- Children with a generally healthy medical status and suitable for treatment under general anesthesia.
- Parents or legal guardians willing to provide written informed consent for participation in the study.
Who cannot join
- Children with systemic diseases or medical conditions that may affect oral health, occlusal function, or the ability to undergo general anesthesia.
- Children with craniofacial anomalies or developmental conditions that may significantly affect occlusion or bite force.
- Primary molars with inadequate remaining tooth structure for full-crown restoration.
- Teeth with advanced pathological root resorption or other conditions contraindicating crown restoration.
- Children with significant parafunctional habits, such as severe bruxism, that may affect bite-force measurements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
faculty of dentistry, Tanta university
Tanta
shaimaa eldesouky, assistant professor, 01008994242, shaimaaeldesouky@dent.tanta.edu.eg
About this study
Official title: Postoperative Bite Force in Children Following Full-Crown Restoration Under General Anesthesia: A Randomized Comparative Study of Bioflx and Zirconia Crowns
This randomized clinical trial aims to compare postoperative bite force following full-crown restoration with preformed Bioflx and zirconia crowns in children undergoing comprehensive dental treatment under general anesthesia. Children aged 4-7 years requiring full-coverage restoration of primary molars will be randomly allocated to receive either Bioflx or zirconia crowns. Occlusal bite force will be assessed before treatment and at predefined postoperative follow-up time points using a digital occlusal analysis system. The study will evaluate changes in occlusal function following placement of the two types of pediatric full-coverage crowns.
Read the detailed description
This randomized clinical trial aims to compare postoperative occlusal bite force following full-crown restoration of primary molars with preformed Bioflx and zirconia crowns in children undergoing comprehensive dental treatment under general anesthesia. Children aged 4-7 years who require full-coverage crown restoration of primary molars will be randomly allocated to receive either a preformed Bioflx crown or a zirconia crown. The crowns will be fitted and cemented according to the respective manufacturers' recommendations, and the final occlusion will be evaluated following crown placement.
Occlusal bite force will be assessed before treatment and at predetermined postoperative follow-up time points using a digital occlusal analysis system. The study will compare changes in bite force following restoration with Bioflx and zirconia crowns to evaluate the recovery of occlusal function after comprehensive dental treatment under general anesthesia.
- Conditions
- Bite Force, Masseter Muscle, Zirconia Crowns, Primary Molars
- Being tested
- Preformed Bioflx Crown, Preformed Zirconia Crown
- Keywords
- bite force, postoperative bite force, Bioflx crown, zirconia crown, primary molar, general anethesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preformed Bioflx CrownProcedure or surgery
Preformed Bioflx pediatric crowns will be used for full-coverage restoration of indicated primary molars in children undergoing comprehensive dental treatment under general anesthesia.
Preformed Zirconia CrownProcedure or surgery
Preformed zirconia pediatric crowns will be used for full-coverage restoration of indicated primary molars in children undergoing comprehensive dental treatment under general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Bioflx Crown Group | Experimental | Children in this group will receive full-crown restoration of indicated primary molars using preformed Bioflx pediatric crowns during comprehensive dental treatment under general anesthesia. Occlusal bite force will be assessed before treatment and at the predefined postoperative follow-up time points using a digital occlusal analysis system. Receives: Procedure: Preformed Bioflx Crown |
| Zirconia Crown Group | Active comparator | Children in this group will receive full-crown restoration of indicated primary molars using preformed zirconia pediatric crowns during comprehensive dental treatment under general anesthesia. Occlusal bite force will be assessed before treatment and at the predefined postoperative follow-up time points using a digital occlusal analysis system. Receives: Procedure: Preformed Zirconia Crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Occlusal Bite Force
Change in occlusal bite force following full-crown restoration with preformed Bioflx or zirconia crowns, measured using a digital occlusal analysis system. Bite force will be expressed as the percentage (%) of total occlusal force contributed by the treated/restored primary molar(s).
Measured: Baseline (before crown placement), immediately after crown cementation, one and three months after treatment
Secondary outcomes (1)
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
Measured: Baseline, immediately after crown placement, and 1 and 3 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bite ForceStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Shaban Mohamed El-desouky, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07825103
- Sponsor's protocol ID
- #R-PED-7-25-3213
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abdelhafez A, Dhar V. Comparative clinical performance of stainless steel, zirconia, and Bioflx crowns in primary molars: a randomized controlled trial. BMC Oral Health. 2025 Apr 18;25(1):585. doi: 10.1186/s12903-025-05869-8.
PubMed 40251538Singh T, Devashish, Kannan A, Chopra SS, Kaur R, Sethi T, Singh R. Bite Force Distribution and Occlusal Adjustment in Stainless Steel Crowns and BioFlx Crowns of Children Aged 4-8 Years. Int J Clin Pediatr Dent. 2026 Feb;19(2):145-149. doi: 10.5005/jp-journals-10005-3407. Epub 2026 Feb 12.
PubMed 41800000
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Bite Force in Children Following Full-Crown Restoration Under General Anesthesia: A Randomized Comparative Study of Bioflx and Zirconia Crowns
- ClinicalTrials.gov ID
- NCT07825103
- Acronym / sponsor ID
- #R-PED-7-25-3213
- Conditions
- Bite Force, Masseter Muscle, Zirconia Crowns, Primary Molars
- Keywords
- bite force, postoperative bite force, Bioflx crown, zirconia crown, primary molar, general anethesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized clinical trial aims to compare postoperative bite force following full-crown restoration with preformed Bioflx and zirconia crowns in children undergoing comprehensive dental treatment under general anesthesia. Children aged 4-7 years requiring full-coverage restoration of primary molars will be randomly allocated to receive either Bioflx or zirconia crowns. Occlusal bite force will be assessed before treatment and at predefined postoperative follow-up time points using a digital occlusal analysis system. The study will evaluate changes in occlusal function following placement of the two types of pediatric full-coverage crowns.
Detailed description
This randomized clinical trial aims to compare postoperative occlusal bite force following full-crown restoration of primary molars with preformed Bioflx and zirconia crowns in children undergoing comprehensive dental treatment under general anesthesia. Children aged 4-7 years who require full-coverage crown restoration of primary molars will be randomly allocated to receive either a preformed Bioflx crown or a zirconia crown. The crowns will be fitted and cemented according to the respective manufacturers' recommendations, and the final occlusion will be evaluated following crown placement.
Occlusal bite force will be assessed before treatment and at predetermined postoperative follow-up time points using a digital occlusal analysis system. The study will compare changes in bite force following restoration with Bioflx and zirconia crowns to evaluate the recovery of occlusal function after comprehensive dental treatment under general anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioflx Crown Group | Experimental | Procedure: Preformed Bioflx CrownChildren in this group will receive full-crown restoration of indicated primary molars using preformed Bioflx pediatric crowns during comprehensive dental treatment under general anesthesia. Occlusal bite force will be assessed before treatment and at the predefined postoperative follow-up time points using a digital occlusal analysis system. |
| Zirconia Crown Group | Active comparator | Procedure: Preformed Zirconia CrownChildren in this group will receive full-crown restoration of indicated primary molars using preformed zirconia pediatric crowns during comprehensive dental treatment under general anesthesia. Occlusal bite force will be assessed before treatment and at the predefined postoperative follow-up time points using a digital occlusal analysis system. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged 4-7 years.
- Children requiring comprehensive dental treatment under general anesthesia.
- Children requiring full-coverage restoration of one or more primary molars with a preformed pediatric crown.
- Primary molars with sufficient remaining tooth structure to support full-crown restoration.
- Children with a generally healthy medical status and suitable for treatment under general anesthesia.
Key exclusion criteria (5 listed)
- Children with systemic diseases or medical conditions that may affect oral health, occlusal function, or the ability to undergo general anesthesia.
- Children with craniofacial anomalies or developmental conditions that may significantly affect occlusion or bite force.
- Primary molars with inadequate remaining tooth structure for full-crown restoration.
- Teeth with advanced pathological root resorption or other conditions contraindicating crown restoration.
- Children with significant parafunctional habits, such as severe bruxism, that may affect bite-force measurements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preformed Bioflx CrownPreformed Bioflx pediatric crowns will be used for full-coverage restoration of indicated primary molars in children undergoing comprehensive dental treatment under general anesthesia. | Procedure or surgery | Bioflx Crown Group |
| Preformed Zirconia CrownPreformed zirconia pediatric crowns will be used for full-coverage restoration of indicated primary molars in children undergoing comprehensive dental treatment under general anesthesia. | Procedure or surgery | Zirconia Crown Group |
Primary outcome
Change in Occlusal Bite Force
Time frame: Baseline (before crown placement), immediately after crown cementation, one and three months after treatment
Change in occlusal bite force following full-crown restoration with preformed Bioflx or zirconia crowns, measured using a digital occlusal analysis system. Bite force will be expressed as the percentage (%) of total occlusal force contributed by the treated/restored primary molar(s).
1 secondary outcome
Occlusal Contacts
Time frame: Baseline, immediately after crown placement, and 1 and 3 month after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Results publication: PubMed 40251538Abdelhafez A, Dhar V. Comparative clinical performance of stainless steel, zirconia, and Bioflx crowns in primary molars: a randomized controlled trial. BMC Oral Health. 2025 Apr 18;25(1):585. doi: 10.1186/s12903-025-05869-8.
- Results publication: PubMed 41800000Singh T, Devashish, Kannan A, Chopra SS, Kaur R, Sethi T, Singh R. Bite Force Distribution and Occlusal Adjustment in Stainless Steel Crowns and BioFlx Crowns of Children Aged 4-8 Years. Int J Clin Pediatr Dent. 2026 Feb;19(2):145-149. doi: 10.5005/jp-journals-10005-3407. Epub 2026 Feb 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preformed Bioflx Crown and Preformed Zirconia Crown in people with Bite Force and Masseter Muscle, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact shaimaa eldesouky, assistant professor (01008994242, shaimaaeldesouky@dent.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Occlusal Bite Force (time frame: Baseline (before crown placement), immediately after crown cementation, one and three months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07825103, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.