Clinical trial
A Pilot Study to Evaluate Sampling Methods for Subgingival Plaque
Name
2016135
Description
To identify a sampling method for collecting subgingival plaque
Trial arms
Trial start
2016-06-01
Estimated PCD
2016-06-01
Trial end
2016-06-01
Status
Completed
Treatment
Stannous Fluoride
Arms:
2-step system
Size
20
Primary endpoint
Subgingival plaque
4 weeks
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}
Updated at
2023-11-15
1 organization
1 product
1 indication
Organization
Procter and GambleProduct
Stannous FluorideIndication
Subgingival Plaque