A Pilot Study to Evaluate a Molecular Method for Plaque

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02574221
• Date of registration: 09/10/2015
• Prospective Registration: No
• Primary sponsor: Procter and Gamble
• Public title: A Pilot Study to Evaluate a Molecular Method for Plaque
• Scientific title: A Pilot Study to Evaluate the Sensitivity of a Novel Molecular Method for Plaque Toxicity
• Date of first enrolment: August 2015
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02574221
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Double (Participant, Investigator).
• Phase: N/A

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion Criteria:

In order to be included in the study, each subject must:

- Provide written informed consent to participate in the study;

- Be 18 years of age or older;

- Agree not to participate in any other oral/dental product studies during the course of
this study;

- Agree to delay any elective dentistry (including dental prophylaxis) until the study
has been completed;

- Agree to maintain their current oral hygiene routine between the Screening and
Baseline Visit and not to add/change their oral care products during this time;

- Agree to refrain from any form of non-specified oral hygiene during the treatment
periods (after the Baseline Visit), including but not limited to the use of products
such as floss or whitening products;

- Agree to return for all scheduled visits and follow study procedures;

- Must have at least 16 natural teeth;

- Be in good general health, as determined by the Investigator/designee based on a
review of the health history/update for participation in the study;

- Agree to refrain from all oral hygiene for at least 12 hours prior to each visit;

- Agree to refrain from eating, chewing gum, drinking and using tobacco for 4 hours
prior to each visit;

- Have at least 20 bleeding sites (sites with a score of 1 or 2 on the GBI index);

- Have minimum 3 sampling sites with bleeding and pocket depth =3mm but not deeper than
4mm;

- Have minimum 3 sampling sites without bleeding and with pocket depth =2mm.

Exclusion Criteria:

Subjects are excluded from study participation where there is evidence of:

- Have had a dental prophylaxis within 2 weeks of plaque sampling visits;

- Have taken antibiotics or used anti-gingivitis / anti-bacterial oral care products
such as chlorhexidine or Listerine within 2 weeks of plaque sampling visits;

- Have rampant caries, open or untreated caries, or advanced periodontitis requiring
prompt treatment;

- Need an antibiotic prophylaxis prior to dental visits;

- A history of hypersensitivity to oral care products containing stannous fluoride;

- A history of hypersensitivity to dyes (from products containing food dyes);

- Present with any disease or condition(s) that could be expected to interfere with
examination procedures or the subject's safe completion of the study; or

- Are pregnant (Self-reported) or lactating.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Plaque

Gingivitis

Intervention(s)

Drug: stannous fluoride toothpaste

Drug: cavity protection toothpaste

Primary Outcome(s)

plaque scores [Time Frame: baseline]

plaque scores [Time Frame: week 8]

Secondary Outcome(s)

gingivitis score [Time Frame: baseline]

gingivitis score [Time Frame: week 8]

Secondary ID(s)

2015049

Source(s) of Monetary Support

Please refer to primary and secondary sponsors