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

J Clin Periodontol. 2009 May;36(5):419-27. doi: 10.1111/j.1600-051X.2009.01388.x.

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.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Bone Density Conservation Agents / administration & dosage
  • Bone Density Conservation Agents / adverse effects
  • Bone Density Conservation Agents / therapeutic use*
  • Chronic Periodontitis / drug therapy
  • Chronic Periodontitis / therapy*
  • Dental Plaque Index
  • Dental Scaling
  • Diphosphonates / administration & dosage
  • Diphosphonates / adverse effects
  • Diphosphonates / therapeutic use*
  • Disease Progression
  • Female
  • Follow-Up Studies
  • Gingival Hemorrhage / drug therapy
  • Gingival Hemorrhage / therapy
  • Gingival Recession / drug therapy
  • Gingival Recession / therapy
  • Humans
  • Injections, Intramuscular
  • Male
  • Oral Hygiene
  • Periodontal Attachment Loss / drug therapy
  • Periodontal Attachment Loss / therapy
  • Periodontal Pocket / drug therapy
  • Periodontal Pocket / therapy
  • Root Planing
  • Single-Blind Method
  • Treatment Outcome

Substances

  • Bone Density Conservation Agents
  • Diphosphonates
  • 6-amino-1-hydroxyhexane-1,1-diphosphonate