NCT Number: NCT02841839
A Study to Evaluate Sampling Methods for Subgingival Plaque
To identify a sampling method for collecting subgingival plaque
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
Subgingival plaque
Time frame: 4 weeks
subgingival plaque quantity measured by periopaper or curette sampling
Sponsors and collaborators
Lead sponsor
Procter and Gamble
Industry
Registry information
Official study title
A Pilot Study to Evaluate Sampling Methods for Subgingival Plaque
Important dates
- Study start
- 2016
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Jul 22, 2016
- Registry last updated
- Nov 15, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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