Repair Versus Replacement of Failed Restorations in Primary Teeth
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-8
SponsorUniversity of Sao Paulo
About this trial
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%).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Repair of Failed Restoration
Procedure/SurgeryPrior 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
Procedure/SurgeryPrior 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
Treatment groups
382 Participants
are divided into 2 treatment groupsGroup A: RepairExperimental treatment 1 intervention
Group B: ReplacementActive comparator 1 intervention
Trial outcomes
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).
Time frame
24 monthsSecondary outcomes
1
Treatment success rate
Treatment success at 24 months will be assessed as a binary outcome. All participants will be clinically evaluated at 24 months, and each treated tooth will be classified as either successful or unsuccessful. Treatment will be considered successful when the treated tooth requires no operative reintervention during the 24-month follow-up period and remains asymptomatic, according to the clinical criteria described above. Natural exfoliation of the treated tooth during the follow-up period will also be considered a successful outcome. Treatment failure will be defined as the need for operative reintervention due to disease progression or treatment failure, including endodontic treatment or extraction.
Time frame
24 months2
Parents' and Child's Preference
Before randomization, parents or guardians and the child will receive a standardized explanation of the two therapeutic approaches under investigation (replacement and repair of restorations). To aid comprehension, illustrative images generated by artificial intelligence will be presented, depicting each procedure in a standardized manner. Parents or guardians and the child will then be asked: "If you could choose, which treatment would you prefer?" Responses will be recorded as: replacement, repair, or no preference.
Time frame
Before randomization and prior to treatment3
Treatment Time
The total treatment time will be measured by a research assistant using a digital stopwatch. Timing will start at the beginning of the clinical intervention and stop immediately after its completion. Time will be recorded and expressed in minutes (min).
Time frame
From the beginning to the completion of the treatment procedure4
Child's perception of treatment measured by the Facial Image Scale
The child's perception of the treatment will be assessed immediately after completion of the procedure using the Facial Image Scale (FIS). The scale consists of five facial images scored from 1 to 5, ranging from a very happy expression (score 1) to a very sad expression (score 5). Higher scores indicate a more negative perception of the treatment, whereas lower scores indicate a more positive perception. The scale will be presented by a research assistant, in the absence of the operator, in order to minimize the professional's influence on the child's response. The child will be asked to indicate the image that best represents how they felt during the treatment, following the question: "How did you feel during the treatment?"
Time frame
Immediately after the procedure (Day 0)Sponsors and contacts
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Source ClinicalTrials.gov
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