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ORIGINAL RESEARCH Table of Contents   
Year : 2018  |  Volume : 29  |  Issue : 6  |  Page : 732-738
An open-label, interventional, single-center, prospective clinical study to evaluate the efficacy and safety of “AHPL/AYTAB/1514” in patients suffering from halitosis


1 Department of Pedodontics and Preventive Dentistry, M.A. Rangoonwala College of Dental Sciences and Research Centre, Pune, Maharashtra, India
2 R and D Center, Ari Healthcare Private Limited, Pune, Maharashtra, India
3 Department of Preventive and Pediatric Dentistry, M.A. Rangoonwala College of Dental Sciences and Research Centre, Pune, Maharashtra, India
4 Department of Periodontics, M.A. Rangoonwala College of Dental Sciences and Research Centre, Pune, Maharashtra, India
5 Department of Medical Services, R and D Center, Ari Healthcare Private Limited, Pune, Maharashtra, India

Correspondence Address:
Dr. Sanjay Nipanikar
Ari Healthcare Private Limited, Unit No. 401, International Biotech Park, BTS 2, Building, Chrysalis Enclave, 4th Floor, Plot No. 2A, MIDC Phase II, Hinjewadi, Pune - 411 057, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijdr.IJDR_201_16

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Objectives: The main objective of the study was to assess the efficacy and safety of AHPL/AYTAB/1514 tablet in patients suffering from halitosis. Methodology: Fifty four patients were recruited in the study. Patients were advised to take maximum two tablets or at least one tablet four times a day (depending on tolerability of the drug) orally for 60 days. Patients were called for follow-up on day 15, 30, 45, 60, and 75. Data describing quantitative measures were expressed as mean ± standard deviation comparison of variables representing categorical data were performed using Chi-square test, Student's t-test, or Wilcoxon Sign Rank test. Results: At the end of the treatment, significant reduction in halitosis, gingivitis index, and dental plaque index was observed. Even after stoppage of treatment for 15 days after 60 days of treatment, there was no relapse in halitosis. Few patients experienced sore throat, cough, and common cold during the study, which were resolved with the treatment of AHPL/AYTAB/1514 tablet. No significant change in vital parameters and most of the safety laboratory parameters were observed. No staining on tooth was observed in any patient. Almost all patients showed excellent improvement as per global evaluation done by the physician and patient. Almost all patients showed excellent tolerability to the study drug. Few patients showed mild AE, which were resolved without stoppage of study drug. Conclusion: The study provides good evidence in support of the efficacy and safety of the AHPL/AYTAB/1514 tablet in halitosis.


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