Is clindamycin-modified triple antibiotic paste better than iodoform-based medicament for the treatment of non-vital primary molars using LSTR technique – A randomised clinical trial

Abstract

Objectives: The objectives of this study were to evaluate and compare the success rate of local application of iodoform-based obturating material (Pulpotec – [Produits Dentaires S.A., Switzerland]) and clindamycin-modified triple antibiotic paste (ClinM-TAP) in pulp chamber using minimally invasive endodontic treatment of carious primary molars indicated for pulpectomy, for 12 months, using clinical and radiographic parameters. Materials and Methods: A randomised clinical trial was conducted in 60 children in the age group of 3–8 years reporting carious primary molars with symptoms of irreversible pulpitis and pulpal involvement clinically, allocated into Group 1 (30) and Group 2 (30). In Group 1, Lesion sterilisation and tissue repair (LSTR) was done using Pulpotec (Produits Dentaires S.A., Switzerland) as medicament and in Group 2, ClinM-TAP (Clindamycin-modified triple antibiotic paste) was used as medicament. Clinical follow-up was done at 3, 6 and 12 months; radiographic follow-up was done at 6 and 12 months. Clinical parameters compared were tenderness on percussion, spontaneous pain, intraoral swelling and sinus/fistula. Radiographic comparison was done based on furcation radiolucency, root resorption and bone regeneration. Both intergroup and intragroup statistical analysis was done using Chi-square test or Fisher exact test, Cochran’s Q Test and Mann–Whitney U-Test for the test of significance. All the statistical tests were performed at 5% significance level. Results: The mean age of patients in the study was 5.25 ± 1.3years with 45% males and 55% females. Both groups showed significant improvement in terms of clinical symptoms from baseline to 12 months. On intergroup comparison clinical parameters, TOP was present in 11.2% and 44% of cases at the end of 12 months in Groups 1 and 2, respectively (P < 0 0.05). On intergroup comparison of radiographic parameters, at the end of 12 months, furcation radiolucency was seen in 32% and 73% (P < 0.05) and root resorption was seen in 16% and 30% cases in Group 1 and 2, respectively (P > 0.05). Overall clinical success rate of Group 1 and Group 2 was 88% and 50%, respectively (P < 0.05) and radiographic success rate was 60% and 27%, respectively (P < 0.05). Conclusion: LSTR using Pulpotec as a medicament has shown promising results in the present study. It could be a better alternative to conventional endodontic treatment in primary teeth. In the present study, ClinM-TAP has shown poor radiographic success; hence, it should be used with caution.