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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02841839
Other study ID # 2016135
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2016
Est. completion date June 2016

Study information

Verified date November 2023
Source Procter and Gamble
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To identify a sampling method for collecting subgingival plaque


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 use the acclimation toothpaste together with their regular brush and refrain from any other oral care products (including floss and mouth rinse) between the Screening and Baseline Visit; - Agree to use the treatment products and 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, mouth rinse, 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 10-20 bleeding sites; and - Have minimum 6 sampling sites with bleeding and pocket depth =2mm but not deeper than 4mm. Exclusion Criteria: - 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; - Taking allergy medication or any other medication that can affect salivary flow such as an antihistamine; - Need an antibiotic prophylaxis prior to dental visits; - A history of hypersensitivity to oral care products containing hydrogen peroxide or stannous fluoride; - A history of hypersensitivity to products containing sodium lauryl sulfate (SLS); - Are pregnant (Self-reported) or lactating; or - Have any condition or disease, as determined by the Investigator/Designee based on a review of the medical history, which could be expected to interfere with examination procedures or with the subject's safe completion of the study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Stannous Fluoride


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Procter and Gamble

Outcome

Type Measure Description Time frame Safety issue
Primary Subgingival plaque subgingival plaque quantity measured by periopaper or curette sampling 4 weeks
See also
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Recruiting NCT05355740 - The Effect of Post-surgical Chlorhexidine Mouth Washing on the Sub-gingival Periodontal Microbiome A Pilot Study
Completed NCT03296657 - Analysis of Stannous Fluoride in GCF and Subgingival Plaque N/A