Stannous Fluoride and Gingivitis

NCT ID: NCT05326373

Last Updated: 2022-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-11
• Study Completion Date: 2022-06-13

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.

Conditions

Gingivitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Healthy Group

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

Group Type: ACTIVE_COMPARATOR

Stannous fluoride

Intervention Type: DRUG

brush twice daily with stannous fluoride toothpaste for 8 weeks

Unhealthy Group

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

Group Type: ACTIVE_COMPARATOR

Stannous fluoride

Intervention Type: DRUG

brush twice daily with stannous fluoride toothpaste for 8 weeks

Interventions

Stannous fluoride

brush twice daily with stannous fluoride toothpaste for 8 weeks

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Procter and Gamble

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Salus Research

Fort Wayne, Indiana, United States

Countries

United States

References

Ramji N, Xie S, Bunger A, Trenner R, Ye H, Farmer T, Reichling T, Ashe J, Milleman K, Milleman J, Klukowska M. Effects of stannous fluoride dentifrice on gingival health and oxidative stress markers: a prospective clinical trial. BMC Oral Health. 2024 Aug 30;24(1):1019. doi: 10.1186/s12903-024-04785-7.

Reference Type: DERIVED

PMID: 39215289 (View on PubMed)

Other Identifiers

2022001

Identifier Type: -

Identifier Source: org_study_id