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.
OBJECTIVE
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.


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.
Graziani
Filippo
F
Department of Surgery, Section of Oral Surgery, University of Pisa, Pisa, Italy. f.graziani@med.unipi.it
Cei
Silvia
S
Guerrero
Adrian
A
La Ferla
Fabio
F
Vano
Michele
M
Tonetti
Maurizio
M
Gabriele
Mario
M
D000328:Adult; D050071:Bone Density Conservation Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D055113:Chronic Periodontitis / Q000188:drug therapy / Q000628:therapy*; D003774:Dental Plaque Index; D012534:Dental Scaling; D004164:Diphosphonates / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018450:Disease Progression; D005260:Female; D005500:Follow-Up Studies; D005884:Gingival Hemorrhage / Q000188:drug therapy / Q000628:therapy; D005889:Gingival Recession / Q000188:drug therapy / Q000628:therapy; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D009910:Oral Hygiene; D017622:Periodontal Attachment Loss / Q000188:drug therapy / Q000628:therapy; D010514:Periodontal Pocket / Q000188:drug therapy / Q000628:therapy; D016745:Root Planing; D016037:Single-Blind Method; D016896:Treatment Outcome
D050071:Bone Density Conservation Agents; D004164:Diphosphonates; C053389:6-amino-1-hydroxyhexane-1,1-diphosphonate