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SANZ et al .
Available evidence Seven placebo-controlled RCTs ( n = 348), all from the same research group, on local delivery of 1% alendronate gel (six studies) and 0.5% zolendronate gel (one study) in infrabony or furcation Class II defects were identified. A meta-analysis on PPD reduction at 6 months in five RCTs ( n = 228) using either single or multiple sites per patient in in - frabony defects was undertaken. Two placebo-controlled RCTs ( n = 90) evaluated systemic administration of BPs (alendronate and risedronate). Risk of bias Of the nine studies included, two were at high risk of bias and seven presented some concerns in at least one of the domains of the risk of bias assessment tool. One study was underpowered. All studies on local BPs were published by the same research group. While pharmaceutical companies provided bisphosphonates for local application in the included studies, the level of involvement of industry in the analysis and interpretation of the results is unclear. Consistency Nine RCTs were available, two involving systemic administration of BPs. No meta-analysis was therefore undertaken for systemic BPs. Out of the seven RCTs involving local application of BPs, five were on infrabony defects (four employed 1% Alendronate gel and one study used 0.5% Zolendronate gel), while two were undertaken on furcation Class II defects (all using 1% Alendronate gel). A meta- analysis of five studies using single or multiple sites per patient demonstrated a significant benefit in terms of PPD reduction of 2.15 mm (95% CI [1.75; 2.54]) after 6 months from non-surgical periodontal therapy in infrabony defects, with a low level of het - erogeneity ( I 2 = 47.3%). Clinical relevance The results of the two studies on systemic BPs were poorly compa - rable as they were undertaken in different populations and involved different confounding factors (e.g. smoking). Although the mean estimates suggested adjunctive benefits from adjunctive use of BP gels, the combined use of studies consid - ering single and multiple sites per patient in the meta-analysis should be taken into consideration. Balance of benefits and harm Both systemic and local BPs were well-tolerated in the studies re - ported in the systematic review and were not associated with severe adverse reactions. Economic considerations There is an additional cost associated with the use of bisphospho - nates that is borne by the patient.
Ethical and legal considerations The balance of recognized potential severe risks (e.g. osteochemone - crosis of the jaws) versus benefits resulted in a consensus that systemic administration of BPs should not be recommended in the clinical man - agement of periodontal bone loss. It is important to note that BP gel formulations are “off-label” and an approved formulation with appropri - ate quality control (GMP) and patient safety validation is not available. Applicability The same research group/centre published all data on locally de - livered BPs; therefore, the generalizability of the results requires substantiating in future larger (multicentre) RCTs, with multilevel analyses accounting for potential confounding factors (e.g. medical history, smoking history). R2.10 | Does adjunctive use of systemic/local non-steroidal anti-inflammatory drugs to subgingival instrumentation improve the clinical outcomes? Evidence-based recommendation (2.10) We recommend not to use systemic or local non-steroidal anti-inflammatory drugs (NSAIDs) as an adjunct to subgingival instrumentation Supporting literature Donos et al. (2019) Quality of evidence Two placebo-controlled RCTs ( n = 88) on local application (1% flurbiprofen toothpaste; irrigation with 200 ml buffered 0.3% acetylsalicylic acid); two placebo-controlled RCTs ( n = 133) on systemic applications (celecoxib, diclofenac potassium) Grade of recommendation Grade A—↓↓ Strength of consensus Strong consensus (1.3% of the group abstained due to potential CoI)
Background
Intervention Periodontitis is an inflammatory disease in which altered immune- inflammatory responses to a dysbiotic biofilm drives connective tissue destruction and bone loss. It is reasonable therefore that non- steroid anti-inflammatory drugs (NSAIDs), may be effective as ad - junctive periodontal therapies. Available evidence Two placebo-controlled RCTs ( n = 88) on local application, one using 1% flurbiprofen toothpaste twice daily for 12 months and a second using subgingival daily irrigation with 200 ml buffered 0.3% acetyl - salicylic acid, were identified. Two placebo-controlled RCTs ( n = 133) on systemic applications, one RCT using systemic celecoxib (200 mg daily 6 months) and another using a cyclical regime of diclofenac po - tassium (50 mg 2-months, then 2 months off, then 2 months on),
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