AIM: To determine if the adjunctive use of intra-muscular neridronate (NE) during non-surgical periodontal treatment (PT) provides, in patients with generalized chronic periodontitis (GCP), adjunctive benefits as compared with PT alone 3 months after the completion of a 3-month NE therapy. MATERIAL AND METHODS: Sixty GCP healthy patients were randomly assigned to control (CG) or test group (TG). CG patients received PT only. Thirty subjects in TG also received adjunctive NE (12.5 mg in an i.m. injection/week for 3 months). Clinical parameters were evaluated at baseline, at the end of NE treatment (3 months after PT) and 3 months after the completion of NE treatment (6 months after the beginning of PT). RESULTS: Groups were balanced at baseline and all clinical parameters showed improvement between baseline and follow-ups. At 6 months improvements from baseline at sites with deep pocket depth (>or=7 mm) were 3.2 mm [95% confidence interval (CI): 2.7-3.9] in CG and 3.0 mm (95% CI: 2.3-3.8) in TG with a non-significant difference of 0.2 mm (95% CI: -1.0-0.5; ANCOVA; p=0.549) between groups. Secondary outcomes did not show significant differences between groups. No major adverse events were reported. CONCLUSIONS: The adjunctive use of NE during PT did not result in additional short-term improvements in periodontal conditions of GCP patients when compared with PT.
Lack of short-term adjunctive effect of systemic neridronate in non-surgical periodontal therapy of advanced generalized chronic periodontitis: an open label-randomized clinical trial
GRAZIANI, FILIPPO;CEI, SILVIA;VANO, MICHELE;GABRIELE, MARIO
2009-01-01
Abstract
AIM: To determine if the adjunctive use of intra-muscular neridronate (NE) during non-surgical periodontal treatment (PT) provides, in patients with generalized chronic periodontitis (GCP), adjunctive benefits as compared with PT alone 3 months after the completion of a 3-month NE therapy. MATERIAL AND METHODS: Sixty GCP healthy patients were randomly assigned to control (CG) or test group (TG). CG patients received PT only. Thirty subjects in TG also received adjunctive NE (12.5 mg in an i.m. injection/week for 3 months). Clinical parameters were evaluated at baseline, at the end of NE treatment (3 months after PT) and 3 months after the completion of NE treatment (6 months after the beginning of PT). RESULTS: Groups were balanced at baseline and all clinical parameters showed improvement between baseline and follow-ups. At 6 months improvements from baseline at sites with deep pocket depth (>or=7 mm) were 3.2 mm [95% confidence interval (CI): 2.7-3.9] in CG and 3.0 mm (95% CI: 2.3-3.8) in TG with a non-significant difference of 0.2 mm (95% CI: -1.0-0.5; ANCOVA; p=0.549) between groups. Secondary outcomes did not show significant differences between groups. No major adverse events were reported. CONCLUSIONS: The adjunctive use of NE during PT did not result in additional short-term improvements in periodontal conditions of GCP patients when compared with PT.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
