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Stannous Fluoride and Gingivitis

Sponsor
Procter and Gamble (Industry)
Overall Status
Completed
CT.gov ID
NCT05326373
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
2.1
Actual Duration (Months)
19.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

8-week study using stannous fluoride toothpaste on subjects with gingivitis ("unhealthy") and without gingivitis ("healthy"). Gingivitis index will be performed at BL, Week 4 and Week 8. A number of biological samples will be collected at each timepoint.

Condition or Disease Intervention/Treatment Phase
  • Drug: Stannous fluoride
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Pilot Study to Evaluate Gingivitis Using Traditional and Molecular Methods
Actual Study Start Date :
Apr 11, 2022
Actual Primary Completion Date :
Jun 13, 2022
Actual Study Completion Date :
Jun 13, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Healthy Group

Subjects without gingivitis (</= 3 bleeding sites) will use stannous fluoride toothpaste

Drug: Stannous fluoride
brush twice daily with stannous fluoride toothpaste for 8 weeks
Active Comparator: Unhealthy Group

Subjects with gingivitis (>/= bleeding 20 sites) will use stannous fluoride toothpaste

Drug: Stannous fluoride
brush twice daily with stannous fluoride toothpaste for 8 weeks

Outcome Measures

Primary Outcome Measures

  1. MGI [8 weeks]

    Modified Gingival Index- validated assessment of gingival health looking at inflammation based on 4-point range 0 (normal gingiva) to 4 (severe inflammation).

  2. GBI [8 weeks]

    Gingival Bleeding Index- validated assessment of gingival health looking at bleeding based on 2-point range 0 (Absence of bleeding) to 2 (Immediate bleeding)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Be 18 years of age or older;

  • Provide written informed consent and receive a signed copy of consent;

  • Agree to delay any elective dentistry, including dental prophylaxis, and to report any non-study dentistry received during the course of this study;

  • Agree not to participate in any other oral care studies for the duration of this study;

  • Agree to refrain from any form of non-specified oral hygiene during the treatment periods, 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;

  • 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.

For Unhealthy Group:

  • Have at least 20 bleeding sites (sites with a score of 1 or 2 on the Screening GBI exam); and

  • Have a minimum of 3 sampling sites with bleeding and pocket depth >/=3mm but not deeper than 4mm at the Screening visit.

For Healthy Group:

  • Have a maximum of 3 bleeding sites (sites with a score of 1 or 2 on the Screening GBI exam); and

  • No pockets deeper than 2mm.

Exclusion Criteria:

  • Self-reported pregnancy or the intent to become pregnant anytime during the course of the study;

  • Inability to comply with study procedures;

  • Rampant caries, open or untreated caries, or advanced periodontitis requiring prompt treatment;

  • Severe periodontal disease, including but not limited to purulent exudate, generalized mobility, and/or severe recession;

  • Fixed orthodontic appliances or attachments for aligner treatment;

  • Having had a dental prophylaxis within 2 weeks of plaque sampling visits;

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

  • Needing an antibiotic prophylaxis prior to dental visits;

  • Presenting 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

  • Having any condition or disease, as determined by the Investigator/Designee which could be expected to interfere with examination procedures or with the subject's safe completion of the study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Salus Research Fort Wayne Indiana United States 46825

Sponsors and Collaborators

  • Procter and Gamble

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Procter and Gamble
ClinicalTrials.gov Identifier:
NCT05326373
Other Study ID Numbers:
  • 2022001
First Posted:
Apr 13, 2022
Last Update Posted:
Jun 16, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Gingivitis
Fluorides
Tin Fluorides

Study Results

No Results Posted as of Jun 16, 2022