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Can a tooth-colored, one-visit space saver replace the metal band-and-loop in kids?

NCT ID NCT07730944

Disease control Sponsor: Ali Assiry Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time

Summary

This trial tests whether a new glass-fiber space maintainer can match the standard metal band-and-loop device in children aged 5 to 8 who lost a baby molar early on both sides of the mouth. Each child gets one type on each side, and the study tracks how well each stays in place, gum health, cavities, and space preservation over nine months. The goal is to see if the glass-fiber option offers a faster, better-looking alternative without sacrificing performance.

What this could mean

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

Active substance
a glass fiber-reinforced composite resin space maintainer (GFRCR) placed in one visit, compared with a conventional stainless-steel band-and-loop space maintainer
What this could lead to
If it works, children who lose a baby molar early could get a tooth-colored, single-visit space maintainer that works as well as the metal one, with less chair time and better looks.
What could go wrong
This is a small, early trial with only 20 children, so results may not apply to all kids. The new material might break or fall off more often than the metal version.

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

20 people

The number who actually took part.

Started

Apr 2026

Finished

Jul 2026

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. Bilateral premature loss of comparable primary molars indicated for extraction or recently extracted. No measurable space loss at the extraction sites. Presence of suitable mesial and distal abutment teeth adjacent to the edentulous space. Buccal surfaces of abutment teeth free of dental caries. Class I occlusion or normal primary molar relationship. Presence of succedaneous permanent teeth with no more than one-half of root formation. Root resorption of the abutment teeth involving less than one-third of the root length. Presence of the bony crypt over the succedaneous tooth germ. Written informed consent obtained from a parent or legal guardian. Exclusion Criteria: * Existing space loss at the extraction site. Pathological lesions involving the jaws or teeth. Malocclusion or abnormal oral musculature. Systemic diseases or medical conditions affecting dental treatment. Abutment teeth with dental caries or inadequate structure for appliance placement. Root resorption of abutment teeth exceeding one-third of the root length. Advanced development or absence of the permanent successor. Inability to attend scheduled follow-up visits or lack of parental consent.

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Conditions

The condition(s) this trial relates to.

Malocclusion Tooth Loss

As listed by the trial registrant

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

Malocclusion Premature loss of primary teeth Space maintenance

Contacts and locations

Locations

  • Pediatric Dentistry Clinic, Faculty of Dentistry, Najran University

    Najran, Najran Region, 55461, Saudi Arabia

More trials for these conditions

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