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Can a new crown help kids chew better after tooth decay?

NCT ID NCT07786805

Disease control Sponsor: Tanta University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 26, 2026 · Last updated Sep 01, 2026 · Updated 3 times

Summary

This study looks at how well children regain their chewing strength after getting a crown on a decayed baby molar. It compares two types of crowns: a newer BioFlx crown and the standard stainless-steel crown. Thirty children aged 5 to 8 with tooth decay will receive one of these crowns, and their bite force and jaw muscle activity will be measured before and after treatment. The goal is to see if the BioFlx crown works as well as the traditional option in helping kids chew normally again.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Preformed BioFlx Crown or Preformed Stainless Steel Crown (dental crowns used to restore decayed primary molars)
What this could lead to
If BioFlx crowns restore bite force as well as or better than stainless-steel crowns, they could become a preferred option for pediatric dental restorations, improving chewing function and quality of life in children.
What could go wrong
This is a small, early-stage study (30 children) and results may not apply to all children. Crowns may fail, cause discomfort, or not fully restore normal bite force, and long-term outcomes are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 8 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. * Children with normal overjet and overbite. * Children without clinically evident malocclusion. * Children without parafunctional oral habits. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

dental caries

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bite force Masseter muscle Stainless-steel crown

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • faculty of dentistry, Tanta university

    Tanta, Cairo Governorate, 31527, Egypt

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