Repair Versus Replacement of Failed Restorations in Primary Teeth

NCT07813065 | Not Yet Recruiting

• 1 other identifier: RepairPEDO
• Study Type: interventional
• Target: 382
• Locations: 1 country
• Sites: 1

Brief 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%).

Conditions

Dental Caries; Restoration Defects; Primary Teeth

Keywords

Tooth, Deciduous; Dental Restoration Failure; Dental Restoration, Permanent; Glass Ionomer Cements;; Child; Randomized Controlled Trial;

Outcome Measures

Primary Outcomes (1)

• Restoration survival rate

  Restoration survival will be assessed based on clinical evaluation of the restorations at 6, 12, 18, and 24 months. A restoration will be considered to have survived when it remains clinically satisfactory according to the following criteria. Single-surface restorations will be considered satisfactory when scored as 0 (restoration present and satisfactory), 1 (restoration present, with a slight marginal defect and/or surface wear of less than 0.5 mm in depth, with no need for repair), or 7 (restoration present, with gradual wear involving larger areas of the restoration but less than 0.5 mm in depth at the deepest point, with no need for repair), according to Frencken et al. (1996). Multiple-surface restorations will be considered satisfactory when scored as 00 (restoration present and satisfactory) or 10 (restoration present, with a slight marginal defect and/or surface wear of less than 0.5 mm in depth, with no need for repair), according to Rôlevald et al. (2006).

  24 months

Secondary Outcomes (8)

• Treatment success rate

  24 months

• Parents' and Child's Preference

  Before randomization and prior to treatment

• Treatment Time

  From the beginning to the completion of the treatment procedure

• Child's perception of treatment measured by the Facial Image Scale

  Immediately after the procedure (Day 0)

• Parents'/Guardians' satisfaction with the treatment using five-point Likert scale

  Immediately after the procedure (Day 0)

Study Arms (2)

Repair

EXPERIMENTAL

Repair of Failed restoration in primary teeth.

Procedure: Repair of Failed Restoration

Replacement

ACTIVE COMPARATOR

Replacement of Failed Restoration in primary teeth.

Procedure: Replacement of Failed Restoration

Interventions

Repair of Failed Restoration PROCEDURE

Prior to the procedure, when needed, local anesthesia with 2% lidocaine and 1:100,000 epinephrine will be used, with relative isolation (cotton rolls and saliva ejector). The defective area will be clinically identified. When present, carious tissue will be selectively removed with hand instruments (dentin curettes) suited to the cavity, preserving as much of the intact original restoration as possible. If no hand instrument fits, the cavity will be enlarged with a small spherical diamond bur at high speed under cooling. The surface will be conditioned with 20% polyacrylic acid (GC Cavity Conditioner) for 10 s, rinsed abundantly, and dried with cotton pellets. For proximal surfaces, a metal matrix and wedge will be placed before the GIC. The capsule will be activated, mixed for 10 s, inserted with an applicator, and adapted by digital pressure with petroleum jelly. Occlusion will be checked with articulating paper and adjusted; surface protection applied with petroleum jelly.

Repair

Replacement of Failed Restoration PROCEDURE

Prior to the procedure, when needed, infiltrative local anesthesia with 2% lidocaine and 1:100,000 epinephrine will be administered. Relative isolation will be used, with cotton rolls and a saliva ejector. Complete removal of the defective restorative material will be performed with spherical diamond burs at high speed under cooling, complemented by round burs at low speed to remove remaining restorative material. Selective removal of carious tissue, when present, will be carried out with hand instruments (dentin curettes) suited to the cavity, preserving soft or leathery dentin according to the depth of the lesion. The new restoration will then be placed following the same protocol described for the repair group: conditioning with 20% polyacrylic acid (GC Cavity Conditioner) for 10 s, rinsing and removal of excess water; placement of a metal matrix and wedge, when needed; insertion of the GIC into the cavity; adaptation by digital pressure with petroleum jelly; occlusal adjustment; a

Replacement

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

University of São Paulo, School of Dentistry

São Paulo, São Paulo, 05508-000, Brazil

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Camila C Cabral, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tamara K Tedesco, PhD

CONTACT

+5511954866622; tamarakt@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 10, 2026
• Study Start (Estimated): October 7, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Start date: After publication of the study results End date: No end date
• Access Criteria: Anonymized individual participant data and the study protocol will be publicly accessible to researchers and other interested users through the designated public data repository. Access will be unrestricted, subject to the repository's terms of use. Only fully anonymized data will be made available, with no information that could reasonably identify individual participants.

Locations

BR (1)