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Repair Versus Replacement of Failed Restorations in Primary Teeth
Sponsor: University of Sao Paulo
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%).
Official title: Repair Versus Replacement of Failed Restorations in Primary Teeth: Protocol for a Non-Inferiority Randomized Clinical Trial
Key Details
Gender
All
Age Range
4 Years - 8 Years
Study Type
INTERVENTIONAL
Enrollment
382
Start Date
2026-10-07
Completion Date
2029-04-01
Last Updated
2026-09-21
Healthy Volunteers
No
Interventions
Repair of Failed Restoration
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.
Replacement of Failed Restoration
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
Locations (1)
University of São Paulo, School of Dentistry
São Paulo, São Paulo, Brazil