Abstract
Purposes
Despite the high number of studies on the biological effects of natural products (NP) and molecules isolated therefrom, only a small part of them reach the clinical phase and become commercially available. In this perspective we make an analysis on how plant research has impacted oral health care over the last 15 years.
Methods
Sixteen major clinical trial registry databases across the globe were searched for completed randomized clinical trials of herbal/natural product interventions (RCTHI) in theperiod 2000–2015.
Results
There was a considerable increase in the number of RCTHI, which points out an interest of academia and industry in the development of novel NP-based therapeutics. There is a trendfor greater heterogeneity of targeted dental conditions, mostly oral mucositis, periodontitis and dental caries. Topical application rather than systemic use predominated in the dental scope as mouthwashes, toothpastes, oral patches and gels have been the most commonly tested pharmaceutical forms. Today, despite the high number of in vitro, in vivo and clinical studies testing NP and/or NP-isolated molecules, only 11% (n = 9) of them are phase IV clinical trials assessing commercially available herbal products. This may be a result of poorly designed, superficial basic research that does not provide evidence to support the clinical testing of NP and derived molecules.
Conclusion
As of now, plant research is promising although still accounts for a modest participation in the oral health care industry due to limited investment and incomplete or inconsistent information from preclinical and clinical testing.
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Abbreviations
- ANZCTR:
-
Australian New Zealand clinical trials registry
- CCTR:
-
Chinese clinical trial registry
- CPPCT:
-
Cuban public registry of clinical trials
- CRIS-K:
-
Clinical research information service of Republic of Korea
- CTRI:
-
Clinical trials registry of India
- EU-CTR:
-
European union clinical trials register
- GCTR:
-
German clinical trials register
- ICMJE:
-
International committee of medical journal editors
- IRCT:
-
Iranian registry of clinical trials
- ISRCTN:
-
The international standard randomised controlled trial number
- JPPN:
-
Japan primary registries network
- NCT:
-
United States trial registry—ClinicalTrials.gov
- NNTR:
-
The Netherlands national trial register
- NP:
-
Natural products
- PACTR:
-
Pan African clinical trial registry
- R&D:
-
Research & development
- RCTHI:
-
Randomized clinical trials of herbal interventions
- ReBEC:
-
Brazilian clinical trials registry
- SLCTR:
-
Sri Lanka clinical trials registry
- TCTR:
-
Thai clinical trials register
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ACKNOWLEDGMENTS AND DISCLOSURES
The authors thank the São Paulo Research Foundation (FAPESP, Brazil, grants no. 2011/15984-0, and no. 2013/25080-7); and the National Council for Scientific and Technological Development (CNPq, Brazil, grant no. 308644/2011-5) for financial support. The authors report no declarations of interest.
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Freires, I.A., Rosalen, P.L. How Natural Product Research has Contributed to Oral Care Product Development? A Critical View. Pharm Res 33, 1311–1317 (2016). https://doi.org/10.1007/s11095-016-1905-5
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DOI: https://doi.org/10.1007/s11095-016-1905-5