Dental Literature Watch · RCT · Pediatric
CARDEC-02: hunting active initial lesions in primary teeth added treatment without preventing a single extra filling
TL;DR
- Detecting active initial caries lesions in primary teeth and directing treatment at them did not reduce the number of surfaces later needing operative intervention compared with managing advanced lesions only (p = 0.827).
- Design: a diagnostic-treatment RCT, not a treatment trial. Children were randomised to a diagnostic threshold, and management followed from what that threshold found.
- 260 children aged 3-6, 222 followed for two years (14.6% attrition); intention-to-treat, negative binomial regression.
- The initial-lesion arm received more non-operative procedures and more professional fluoride sessions; that was the only difference between arms.
- No difference in new lesions, restoration replacement, endodontic treatment, extraction, oral-health-related quality of life or parental satisfaction.
- The authors' word for what the lower threshold produces is overdiagnosis: extra treatment with no relevant benefit to the child.
The study
| Element | Detail |
|---|---|
| Design | Randomised diagnostic-treatment trial (NCT02473107), two diagnostic thresholds, 2-year follow-up, intention-to-treat |
| Population | 260 children aged 3-6 years; 222 followed up (14.6% attrition) |
| Arms | ALL: manage all lesions including active initial lesions · ADV: manage advanced lesions only, initial lesions not individually targeted |
| Primary outcome | Number of surfaces needing new operative intervention at 2 years: no difference, p = 0.827 |
| Secondary: differed | ALL arm had more non-operative procedures and more sessions with professional fluoride application |
| Secondary: no difference | Type of baseline treatment otherwise, new caries lesions, restoration replacement, endodontic treatment, extraction, OHRQoL, parental satisfaction |
| Analysis | Negative binomial regression for count outcomes |
💎 Insight — what this means chairside
Universal prevention beat lesion-by-lesion prevention
Both arms presumably received baseline preventive care; the extra lesion-targeted fluoride sessions in the ALL arm bought nothing measurable.
The practical reading is that the white spots do not each need a procedure.
Both arms presumably received baseline preventive care; the extra lesion-targeted fluoride sessions in the ALL arm bought nothing measurable.
The practical reading is that the white spots do not each need a procedure.
The chart note can still say "active initial lesion"
The trial tested whether treating by that finding changes outcomes, not whether recording it is wrong.
Note it, use it to set recall and home-care intensity, and resist turning it into a billable series of applications.
The trial tested whether treating by that finding changes outcomes, not whether recording it is wrong.
Note it, use it to set recall and home-care intensity, and resist turning it into a billable series of applications.
Parents did not notice a difference either
Quality of life and satisfaction were equal across arms.
Fewer appointments for the same outcome is the version most families would choose.
Quality of life and satisfaction were equal across arms.
Fewer appointments for the same outcome is the version most families would choose.
⚠️ The catch
Why this sits at 3 of 5
A single trial in primary teeth, with the direction of effect being "no benefit", changes the intensity of a routine behaviour rather than the behaviour itself.
It does not reach permanent teeth, adolescents, or high-risk populations where early lesion management may still pay.
A single trial in primary teeth, with the direction of effect being "no benefit", changes the intensity of a routine behaviour rather than the behaviour itself.
It does not reach permanent teeth, adolescents, or high-risk populations where early lesion management may still pay.
The ADV arm's baseline care is not described in the abstract
Whether both arms received the same population-level prevention, and how much, determines what "ignoring initial lesions" actually meant.
Without the full text the comparison is "targeted extra care" versus "whatever the ADV protocol provided".
Whether both arms received the same population-level prevention, and how much, determines what "ignoring initial lesions" actually meant.
Without the full text the comparison is "targeted extra care" versus "whatever the ADV protocol provided".
Two years in a Brazilian university setting
Primary-tooth exfoliation and a single-centre protocol both shape the result.
A 14.6% attrition rate is acceptable, but with a null primary outcome every lost child is a child who could have carried a difference.
Primary-tooth exfoliation and a single-centre protocol both shape the result.
A 14.6% attrition rate is acceptable, but with a null primary outcome every lost child is a child who could have carried a difference.
Abstract only
Effect sizes, confidence intervals, and the breakdown of non-operative procedures are not reported in the abstract.
Effect sizes, confidence intervals, and the breakdown of non-operative procedures are not reported in the abstract.
⚡ Bottom line
- Pre-schooler with several active white-spot lesions and no cavitation → standard preventive care and recall; a lesion-by-lesion treatment plan did not reduce future fillings.
- Tempted to schedule serial fluoride visits for each initial lesion → that was the ALL arm, and it produced more visits with no outcome gain.
- Advanced or cavitated lesions → managed in both arms; this trial does not change their treatment.
- Permanent teeth, adolescents, or very high caries risk → not tested; do not extend the result there.
🧪 Questions
Tap an answer — instant grade, deciding line, and the trap.
A 4-year-old has several active, non-cavitated white-spot lesions on primary molars. The parents ask whether each lesion needs treatment. Which statement is supported by CARDEC-02?
The primary outcome, surfaces needing new operative intervention at two years, did not differ between arms (p = 0.827). Targeted fluoride sessions were exactly what the ALL arm received more of, with no reduction in operative need. Preventing endodontics and extraction was tested as a secondary outcome and did not differ. Resin infiltration was not an arm of this trial, so it offers no evidence for or against it. Trap: the fluoride-session option, which is what most clinics already do and what the trial showed adds visits, not benefit.
Which outcome did differ between the two diagnostic-threshold arms in CARDEC-02?
The ALL arm had more non-operative procedures and more professional fluoride applications; that was the only reported difference. New lesions, quality of life and parental satisfaction were all secondary outcomes that did not differ. Trap: new caries lesions, which is the outcome a lower diagnostic threshold is supposed to improve, and did not.