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Clinical Trials/CTRI/2014/04/004519
CTRI/2014/04/004519CompletedPhase 2

Effect of Test Chewing Gums on Oral Malodour and Oral Pathogens

ITC Limited2 sites in 1 country78 target enrollmentStarted: July 4, 2014Last updated:
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Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
78
Locations
2
Primary Endpoint
Effect assessed in terms of mean reduction in halimeter readings of T-VSC (total volatile sulphur compounds) between the groups
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This will be a randomized, placebo-controlled, double blind study with three parallel arms. Subjects will be randomly assigned equally to one of three groups. One group will be given placebo gums and the remaining two groups will be given different sets of gums containing actives. Approximately 78 subjects will be enrolled from 1 participating center in India. The primary objective of this study will be to evaluate the effect on reduction in volatile sulphur compounds in oral cavity.

Study Design

Study Type
Interventional
Allocation
Permuted block randomization, fixed
Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 50.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Males and females, more than or equal to 18 years to less than or equal to 50 years of age
  • •Halimeter reading of T-VSC (total volatile sulphur compounds) of 200 ppb (parts per billion) or more
  • •Salivary levels of S.
  • •mutans more than 10,000 CFU/mL
  • •Subjects with non-compromised oral health – Subjects should not have untreated caries lesions, clinical signs of gingivitis or periodontal disease, orthodontic patients, oral carcinoma, etc.
  • •Subjects not undergoing antibiotic or antimicrobial therapy
  • •Subjects willing to use standard toothpaste and toothbrush provided to them, throughout the study
  • •Subjects willing to use a tongue cleaner provided to them, throughout the study
  • •Females of child-bearing potential and males should be willing to use adequate methods of contraception
  • •Must be willing and able to give informed consent and comply with the study procedures.

Exclusion Criteria

  • •Subjects using fixed orthodontic appliances
  • •Subjects on drugs for xerostomia, e.g. pilocarpine or cevimeline
  • •Subjects who are allergic to any of the ingredients of the study product
  • •Subjects who have undergone long term antibiotic therapy (for 30 days or more in the past three months)
  • •Subjects who are smokers or current users of narcotics
  • •Subjects using commercial mouthwash, antibacterial tooth paste and dental floss
  • •Pregnant or lactating women
  • •Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.

Outcomes

Primary Outcomes

Effect assessed in terms of mean reduction in halimeter readings of T-VSC (total volatile sulphur compounds) between the groups

Time Frame: From baseline, Day 1 to Day 15

Secondary Outcomes

  • Reduction in counts of S. mutans between the groups(From baseline, Day 1 to Day 15 and Day 21)
  • Mean reduction in halimeter readings of T-VSC between the groups(From baseline, Day 1 to Day 21)
  • Mean reduction in organoleptic measurements between the groups(From baseline, Day 1 to Day 15 and Day 21)
  • Reduction in counts of P.gingivalis between the groups(From baseline, Day 1 to Day 15 and Day 21)
  • Reduction in counts of C.albicans between the groups(From baseline, Day 1 to Day 15 and Day 21)
  • Increase in salivary counts of Lactobacilli sp.(From baseline, Day 1 to Day 15 and Day 2)
  • Improvement in QOL affected by oral malodour(From baseline, Day 1 to Day 15 and Day 21)
  • Improvement in subject-satisfaction after using the investigational products.(From baseline, Day 1 to Day 15 and Day 21)

Investigators

Sponsor Class
Other [fmcg]

Study Sites (2)

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