Cure My Disease

Don't miss your cure!

 Log in / Sign up

Repair versus replacement of failed restorations in primary teeth: protocol for a Non-Inferiority randomized clinical trial

NCT ID NCT07813065

NEW Sponsor: University of Sao Paulo 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Last updated Sep 10, 2026

Summary

Dental caries affect approximately 573 million children globally, and the management of failed restorations is a frequent clinical issue in pediatric dentistry. Although complete replacement of restorations is traditionally the most commonly adopted approach, repair represents a minimally invasive alternative that preserves healthy dental structure and reduces the risk of pulpal complications. Studies in permanent teeth demonstrate that repair may present longevity similar to replacement; however, there is no robust evidence regarding this comparison in primary teeth. This randomized controlled clinical trial, with parallel groups and a 1:1 allocation ratio, aims to evaluate the non-inferiority of repair compared with replacement of failed restorations in primary molars, using encapsulated high-viscosity glass ionomer cement. Children aged 4 to 8 years with at least one failed restoration eligible for repair in primary molars will be included. Randomization will be stratified by number of surfaces. Teeth (n=824) will be randomly allocated to one of the groups: repair or replacement. The primary outcome will be restoration survival at 24 months. Cost-effectiveness will be evaluated as a secondary outcome. Statistical analysis will use Kaplan-Meier curves and Cox regression with shared frailty (¿=5%).

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 382 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Apr 2029

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

4 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 4 to 8 years; * Presence of at least one defective restoration in a primary molar, involving no more than 3 surfaces; * Absence of clinical and radiographic signs of pulp involvement; Exclusion Criteria: * Tooth without pulp vitality or requiring endodontic treatment; * Loose or mobile restoration; * Presence of fistula, abscess, or history of pain; * Tooth mobility incompatible with the physiological exfoliation timeline; * Parents/guardians who do not consent to participation by signing the ICF, or children who do not assent to participate in the study.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Dental caries are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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.

Dental caries Primary teeth Restoration defects

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

  • University of São Paulo, School of Dentistry

    São Paulo, São Paulo, 05508-000, Brazil

More trials for these conditions

Other studies related to the condition(s) this trial covers.