Bite ForceNCT07786805
Bite Force Recovery Following Pediatric Full Crown Restorations
A study testing Preformed BioFlx Crown and Preformed Stainless Steel Crown in people with Bite Force and Stainless-steel Crown, run by Tanta University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Bite Force, Stainless-steel Crown, Masseter Muscle
- What is being tested?
- Preformed BioFlx Crown and Preformed Stainless Steel 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
- Sep 2026to Dec 2026
- 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 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
- Primary molars with more than one-third of the root structure remaining radiographically.
- Children with normal molar relationship.
Show all 9Show fewer
- Children with normal overjet and overbite.
- Children without clinically evident malocclusion.
- Children without parafunctional oral habits.
Who cannot join
- 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.
- Presence of parafunctional habits, such as bruxism or other abnormal occlusal habits.
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, Cairo Governorate, 31527
shaimaa eldesouky, 01008994242, shaimaaeldesouky@dent.tanta.edu.eg
About this study
Official title: Bite Force Recovery Following Pediatric Full Crown Restorations: A Comparative Study of Bioflx and Stainless-steel Crowns
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
Read the detailed description
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.
- Conditions
- Bite Force, Stainless-steel Crown, Masseter Muscle
- Being tested
- Preformed BioFlx Crown, Preformed Stainless Steel Crown
- Keywords
- bite force, dental caries, restoration, Bioflx crown, Stainless steel crowns
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preformed BioFlx CrownProcedure or surgery
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.
Preformed Stainless Steel CrownProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| BioFlx Crown Group | Experimental | Participants will receive preformed BioFlx full-coverage crowns for restoration of eligible primary molars. Receives: Procedure: Preformed BioFlx Crown |
| Stainless Steel Crown Group | Active comparator | Participants will receive preformed stainless steel full-coverage crowns for restoration of eligible primary molars. Receives: Procedure: Preformed Stainless Steel Crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (before crown placement), immediately after crown cementation, one and three months after treatment.
Secondary outcomes (2)
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.
Measured: 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.
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 posted26 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (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
- NCT07786805
- Sponsor's protocol ID
- #R-PED-7-25-3210
- Status last verified
- Aug 2026
- First submitted
- 23 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aishwarya N, Nagarathna C, Poovani S, Thumati P. Comparison of Bite Force and the Influencing Factors Pre- and Post-cementation of Stainless Steel Crown in Children Using T-Scan. Int J Clin Pediatr Dent. 2021 Jan-Feb;14(1):46-50. doi: 10.5005/jp-journals-10005-1900.
PubMed 34326583Owais AI, Al-Battah AH, Abu Alhaija ES. Changes in occlusal bite force following placement of preformed metal crowns on primary molars in 4-6 years old children: a 6 months' follow-up pilot study. Eur Arch Paediatr Dent. 2019 Feb;20(1):9-14. doi: 10.1007/s40368-018-0370-8. Epub 2018 Nov 20.
PubMed 30460643
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bite Force Recovery Following Pediatric Full Crown Restorations: A Comparative Study of Bioflx and Stainless-steel Crowns
- ClinicalTrials.gov ID
- NCT07786805
- Acronym / sponsor ID
- #R-PED-7-25-3210
- Conditions
- Bite Force, Stainless-steel Crown, Masseter Muscle
- Keywords
- bite force, dental caries, restoration, Bioflx crown, Stainless steel crowns
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Aug 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.
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
Detailed description
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.
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 CrownParticipants will receive preformed BioFlx full-coverage crowns for restoration of eligible primary molars. |
| Stainless Steel Crown Group | Active comparator | Procedure: Preformed Stainless Steel CrownParticipants will receive preformed stainless steel full-coverage crowns for restoration of eligible primary molars. |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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.
- Primary molars with more than one-third of the root structure remaining radiographically.
Key exclusion criteria (5 listed)
- 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.
- Presence of parafunctional habits, such as bruxism or other abnormal occlusal habits.
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 CrownEligible 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. | Procedure or surgery | BioFlx Crown Group |
| Preformed Stainless Steel CrownEligible 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. | Procedure or surgery | Stainless Steel Crown Group |
Primary outcome
Occlusal Bite Force Distribution
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.
2 secondary outcomes
Masseter Muscle Activity
Time frame: Baseline (before crown placement), immediately after crown cementation, one month and three months after treatment.
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 31 Aug 2026.
- Background: PubMed 34326583Aishwarya N, Nagarathna C, Poovani S, Thumati P. Comparison of Bite Force and the Influencing Factors Pre- and Post-cementation of Stainless Steel Crown in Children Using T-Scan. Int J Clin Pediatr Dent. 2021 Jan-Feb;14(1):46-50. doi: 10.5005/jp-journals-10005-1900.
- Background: PubMed 30460643Owais AI, Al-Battah AH, Abu Alhaija ES. Changes in occlusal bite force following placement of preformed metal crowns on primary molars in 4-6 years old children: a 6 months' follow-up pilot study. Eur Arch Paediatr Dent. 2019 Feb;20(1):9-14. doi: 10.1007/s40368-018-0370-8. Epub 2018 Nov 20.
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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 Stainless Steel Crown in people with Bite Force and Stainless-steel Crown, 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 9 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 31 Aug 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?
Occlusal Bite Force Distribution (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 NCT07786805, 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 31 Aug 2026.