AIM: The aim of the present analysis of a larger phase 3 clinical trial was to evaluate the efficacy of 1 mg minocycline hydrochloride microencapsulated in 3 mg of resorbable polymer, subgingivally administered as an adjunct to scaling and root planing (SRP) in smokers with chronic periodontitis. MATERIAL AND METHODS: Two hundred and seventy-one patients who smoked were randomized to one of three treatment groups: (1) SRP alone, (2) SRP plus vehicle (polymer without minocycline) or (3) SRP plus minocycline microspheres. Full mouth SRP was performed for all groups at baseline, and vehicle or minocycline microspheres were administered to the appropriate patients at all periodontal pockets > or =5 mm at baseline, 3 and 6 months. Efficacy was evaluated over 9 months. RESULTS: Significantly greater pocket depth reductions with SRP plus adjunctive minocycline microsphere treatment were observed at 1, 6 and 9 months (p<0.05) versus control treatments. At 9 months, smokers treated with SRP plus minocycline microspheres exhibited a pocket depth reduction of 1.19 mm from baseline, as compared to 0.90 mm for smokers treated with SRP alone. The efficacy of adjunctive minocycline microspheres was consistent among all tested smoking subcohorts, including those based on gender, age and smoking exposures. CONCLUSION: These data indicate that treatment with SRP plus locally delivered minocycline microspheres is more effective than SRP alone in reducing pocket depths in smokers with periodontitis.
RCT Entities:
AIM: The aim of the present analysis of a larger phase 3 clinical trial was to evaluate the efficacy of 1 mg minocycline hydrochloride microencapsulated in 3 mg of resorbable polymer, subgingivally administered as an adjunct to scaling and root planing (SRP) in smokers with chronic periodontitis. MATERIAL AND METHODS: Two hundred and seventy-one patients who smoked were randomized to one of three treatment groups: (1) SRP alone, (2) SRP plus vehicle (polymer without minocycline) or (3) SRP plus minocycline microspheres. Full mouth SRP was performed for all groups at baseline, and vehicle or minocycline microspheres were administered to the appropriate patients at all periodontal pockets > or =5 mm at baseline, 3 and 6 months. Efficacy was evaluated over 9 months. RESULTS: Significantly greater pocket depth reductions with SRP plus adjunctive minocycline microsphere treatment were observed at 1, 6 and 9 months (p<0.05) versus control treatments. At 9 months, smokers treated with SRP plus minocycline microspheres exhibited a pocket depth reduction of 1.19 mm from baseline, as compared to 0.90 mm for smokers treated with SRP alone. The efficacy of adjunctive minocycline microspheres was consistent among all tested smoking subcohorts, including those based on gender, age and smoking exposures. CONCLUSION: These data indicate that treatment with SRP plus locally delivered minocycline microspheres is more effective than SRP alone in reducing pocket depths in smokers with periodontitis.
Authors: Y Soeroso; T Akase; H Sunarto; Y Kemal; R Salim; M Octavia; A Viandita; J Setiawan; B M Bachtiar Journal: Ther Clin Risk Manag Date: 2017-03-10 Impact factor: 2.423