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Repair versus replacement of defective resin composite restorations in primary teeth: A randomized clinical trial

Is repair of Adhesive Restorations in deciduous teeth a viable approach? Randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3s8xt3
Enrollment
Unknown
Registered
2018-10-22
Start date
2018-07-25
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deciduous tooth, repair, restoration, survival

Interventions

Restoration replacement (control group): the procedures will be performed in 54 primary molars, after prophylaxis and local anesthesia, under absolute isolation. Spherical diamond drill bits number 10

Sponsors

Universidade Federal do Rio Grande do Sul
Lead Sponsor
Universidade Federal do Rio Grande do Sul
Collaborator

Eligibility

Age
4 Years to 8 Years

Inclusion criteria

Inclusion criteria: Primary molars with restoration of composite resin on occlusal or occlusal-proximal surface that present marginal defects (fracture, cracks); presence of marginal pigmentation and / or caries lesion classified as score 4 of the FDI criterion.

Exclusion criteria

Exclusion criteria: Children who refuse or do not cooperate in the conduct of clinical procedures; teeth without antagonist; teeth with previous endodontic intervention; teeth with clinical and radiographic signs of pulpal alteration; restorations with marginal defects and / or presence of caries lesion classified as FDI criterion score 5.

Design outcomes

Primary

MeasureTime frame
To compare the impact of repair and replacement on survival of composite resin restorations with defects in deciduous teeth, as verified by survival analysis from Kaplan-Meier graphs and with Cox multivariate regression with shared fragility.

Secondary

MeasureTime frame
Cost-effectiveness of repair and replacement of composite resin restorations with defects in deciduous teeth from the Mann-Whitney Test.;Degrees of discomfort and perception of the child during the two treatments, from the t test.;Acceptance of treatment by the child and parents considering the interventions (repair and replacement), from the t test.

Countries

Brazil

Contacts

Public ContactTathiane;Laura Lenzi;Mendes

Universidade Federal do Rio Grande do Sul;Universidade Federal do Rio Grande do Sul

tathilenzi@hotmail.com;laura4mendes@gmail.com+55 (51) 33085023;+55 (51) 33085023

Outcome results

None listed

Source: REBEC (via WHO ICTRP)