A Prospective, Blinded Randomized, Active-controlled Clinical Trial to Evaluate the Success of Double Antibiotic Paste in Pulpally Infected Primary Molars.

BACKGROUND

An irreversibly infected carious primary tooth is often treated by pulpectomy or lesion sterilization and tissue repair (LSTR), with the latter employing a triple mix of antibiotics (metronidazole, ciprofloxacin, and minocycline). Recently, double antibiotic paste (DAP-metronidazole and ciprofloxacin) has been shown to be safer with good antimicrobial efficacy and better biocompatibility with stem cells at concentrations of 1 mg/mL drug mix.

AIM: To assess the clinical and radiographic success of 1 mg/mL DAP and compare it with calcium hydroxide-iodoform pulpectomy in carious infected primary molars.

METHODS

Thirty-three infected primary teeth in 7-10-year-old children were randomly selected and divided into two groups-DAP and pulpectomy. After treatment, teeth were restored with stainless steel crowns. The clinical and radiographic success were evaluated every 3 and 6 months respectively, till 1 year.

RESULTS

The clinical success was 67% (10/15) in the DAP group and 83% (15/18) in the pulpectomy group at 12 months and was statistically nonsignificant (p-value 0.4184). One case each in both groups could not be assessed radiographically because of clinical failure at 3 months. The radiographic success was 36% (5/14) in the DAP group and 53% (9/17) in the pulpectomy group at 12 months and was statistically nonsignificant (p-value 0.3374).

CONCLUSION

The study showed a favorable clinical outcome but a low radiographic success of 1 mg/mL DAP in pulpally infected carious primary molars.

CLINICAL SIGNIFICANCE: In poor prognostic teeth, DAP may be considered a clinically viable option over the conventionally used high-concentration antibiotic pastes for up to 1 year.

HOW TO CITE THIS ARTICLE: Sharma U, Gill NC, Passi S, et al. A Prospective, Blinded Randomized, Active-controlled Clinical Trial to Evaluate the Success of Double Antibiotic Paste in Pulpally Infected Primary Molars. Int J Clin Pediatr Dent 2025;18(6):653-659.