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; Guerrero, Adrián; Ferla, Fabio; Vano, Michele; Tonetti, Maurizio S.; Gabriele, Mario

doi:10.1111/j.1600-051x.2009.01388.x

Cited by 20 publications

(68 citation statements)

References 36 publications

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“…30–35 There have been conflicting findings, with some studies showing improved clinical outcomes with bisphosphonate therapy 33–35 and others showing no additional benefit. 30,31 However, clinical trials evaluating bisphosphonate therapy to improve surgical outcomes are lacking. Furthermore, osteonecrosis of the jaw is considered to be a potential side effect of bisphosphonate therapy and has been associated with surgical trauma to the jaw.…”

Section: Discussionmentioning

confidence: 99%

Teriparatide and Osseous Regeneration in the Oral Cavity

Bashutski¹,

Eber²,

Kinney³

et al. 2010

N Engl J Med

235

174

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BACKGROUND Intermittent administration of teriparatide, a drug composed of the first 34 amino acids of parathyroid hormone, has anabolic effects on bone. Although teriparatide has been evaluated for the treatment of osteoporosis and for the healing of fractures, clinical trials evaluating it for the treatment of osseous conditions of the oral cavity in humans are lacking. METHODS A total of 40 patients with severe, chronic periodontitis underwent periodontal surgery and received daily injections of teriparatide (20 μg) or placebo, along with oral calcium (1000 mg) and vitamin D (800 IU) supplementation, for 6 weeks. The patients were followed for 1 year. The primary outcome was a radiographic linear measurement of alveolar bone level. Secondary outcomes included clinical variables, bone turnover markers in serum and oral fluid, systemic bone mineral density, and quality of life. RESULTS Radiographic linear resolution of osseous defects was significantly greater after teriparatide therapy than after placebo beginning at 6 months, with a mean linear gain in bone at 1 year of 29% as compared with 3% (P<0.001). Clinical improvement was greater in patients taking teriparatide than in those taking placebo, with a reduction in periodontal probing depth of 33% versus 20% (2.42 mm vs. 1.32 mm) and a gain in clinical attachment level of 22% versus 7% (1.58 mm vs. 0.42 mm) in target lesions at 1 year (P = 0.02 for both comparisons). No serious adverse events were reported; however, the number of patients in the study was small. No significant differences were noted with respect to the other variables that were assessed. CONCLUSIONS Teriparatide, as compared with placebo, was associated with improved clinical outcomes, greater resolution of alveolar bone defects, and accelerated osseous wound healing in the oral cavity. Teriparatide may offer therapeutic potential for localized bone defects in the jaw. (Funded by the National Institutes of Health and others; ClinicalTrials.gov number, NCT00277706.)

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Section: Discussionmentioning

confidence: 99%

Teriparatide and Osseous Regeneration in the Oral Cavity

Bashutski¹,

Eber²,

Kinney³

et al. 2010

N Engl J Med

235

174

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“…In an open-label, randomized, clinical trial, Graziani et al investigated the effect of the addition of intramuscular administration of neridronate (12.5 mg weekly for 3 months) in patients with advanced generalized chronic periodontal disease treated with conventional nonsurgical periodontal therapy as compared with the one obtained with conventional treatment alone 52. After discontinuation of treatment, patients were followed-up for 3 months.…”

Section: Other Conditionsmentioning

confidence: 99%

Clinical development of neridronate: potential for new applications

Gatti

Rossini²,

Viapiana³

et al. 2013

TCRM

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Neridronate is an aminobisphosphonate, licensed in Italy for the treatment of osteogenesis imperfecta (OI) and Paget’s disease of bone (PDB). A characteristic property of neridronate is that it can be administered both intravenously and intramuscularly, providing a useful system for administration in homecare. In this review, we discuss the latest clinical results of neridronate administration in OI and PDB, as well as in osteoporosis and other conditions. We will focus in particular on the latest evidence of the effect of neridronate on treatment of complex regional pain syndrome type I.

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“…After the final stage of selection, 8 studies were included and processed for data extraction (Table ). All studies were performed at either universities or health care centres. Figure shows the study identification flow chart according to PRISMA with the reasons for exclusion of articles.…”

Section: Resultsmentioning

confidence: 99%

“…All studies included in the systematic review were RCTs. In all studies , number of subjects ranged between 20 and 73 individuals with mean age ranging between 42.2 and 57.8 years.…”

Section: Resultsmentioning

confidence: 99%

Efficacy of bisphosphonate as an adjunct to nonsurgical periodontal therapy in the management of periodontal disease: a systematic review

Akram

Abduljabbar

Kellesarian

et al. 2016

Brit J Clinical Pharma

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Keywords Bisphosphonates, scaling and root planning, periodontal disease, systematic review AIMSThe aim of this systematic review was to assess the efficacy of bisphosphonate therapy as an adjunct to scaling and root planing (SRP) in the management of periodontitis. METHODSDatabases (MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials and Cochrane Oral Health Group Trials Register databases) were searched up to and including July 2016. The primary outcome was probing depth (PD), and the secondary outcomes were changes in clinical attachment level (CAL) and bone defect (BD) fill. The mean differences (MD) of outcomes and 95% confidence intervals (CI) for each variable were calculated using random effect model. RESULTSEight clinical studies were included. Seven studies used alendronate as an adjunct to SRP; of these, four studies used topical application and three used oral alendronate. Considering the effects of adjunctive bisphosphonates as compared to SRP alone, a high degree of heterogeneity for PD (Q value = 39.6, P < 0.0001, I 2 = 87.38%), CAL (Q value = 13.65, P = 0.008, I 2 = 70.71%), and BD fill (Q value = 53.26, P < 0.0001, I 2 = 92.49%) was noticed among both the groups. Meta-analysis showed a statistically significant PD reduction (MD = -1.18, 95% CI = -1.91 to -0.44, P = 0.002), CAL gain (MD = -0.69, 95% CI = -1.20 to -0.18, P = 0.008) and BD fill (MD = -2.36, 95% CI = -3.64 to -1.08, P < 0.001) for SRP + bisphosphonate treatment vs. SRP alone. CONCLUSIONSAdjunctive bisphosphonate therapy appears to be effective in managing periodontitis, however, due to the potential risk of osteonecrosis of the jaws and short-term follow-up of the studies, their clinical application is debatable. British Journal of Clinical PharmacologyBr J Clin Pharmacol (2017) 83 444-454 444

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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

Abstract: 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.

Cited by 20 publications

References 36 publications

Teriparatide and Osseous Regeneration in the Oral Cavity

Teriparatide and Osseous Regeneration in the Oral Cavity

Clinical development of neridronate: potential for new applications

Efficacy of bisphosphonate as an adjunct to nonsurgical periodontal therapy in the management of periodontal disease: a systematic review

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