Stannous Fluoride and Gingivitis

NCT05326373 | Completed

• 1 other identifier: 2022001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• MGI

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

  8 weeks

• GBI

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

  8 weeks

Study Arms (2)

Healthy Group

ACTIVE COMPARATOR

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

Drug: Stannous fluoride

Unhealthy Group

ACTIVE COMPARATOR

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

Drug: Stannous fluoride

Interventions

Stannous fluoride DRUG

brush twice daily with stannous fluoride toothpaste for 8 weeks

Healthy Group; Unhealthy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Procter and Gamble: lead

Study Sites (1)

Salus Research

Fort Wayne, Indiana, 46825, United States

Location

Related Publications (1)

• 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.

  PMID: 39215289 DERIVED

MeSH Terms

Conditions

Gingivitis

Interventions

Tin Fluorides

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Tin Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 13, 2022
• Study Start: April 11, 2022
• Primary Completion: June 13, 2022
• Study Completion: June 13, 2022
• Last Updated: June 16, 2022

Record last verified: 2022-06

Locations

US (1)