A Clinical Study to Assess the Effects of a Stannous Fluoride Dentifrice on Plaque and Gingivitis

NCT03936556 | Completed Phase 4

• 1 other identifier: 2018004
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this clinical study is to assess the effects of a 0.454% stannous fluoride dentifrice on gingivitis and plaque after 3 months when compared to a negative control.

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (3)

• Löe-Silness Gingivitis Evaluation

  Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).

  Baseline

• Löe-Silness Gingivitis Evaluation

  Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).

  1 Month

• Löe-Silness Gingivitis Evaluation

  Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).

  3 Months

Secondary Outcomes (3)

• Turesky Modified Quigley-Hein Index

  Baseline

• Turesky Modified Quigley-Hein Index

  1 Month

• Turesky Modified Quigley-Hein Index

  3 Months

Study Arms (2)

Marketed Stannous Fluoride Paste

EXPERIMENTAL

Brush twice daily

Drug: Marketed toothpaste

Marketed Cavity Protection Toothpaste

PLACEBO COMPARATOR

Brush twice daily

Drug: Marketed Cavity Protection Toothpaste

Interventions

Marketed toothpaste DRUG

Marketed stannous fluoride (0.454%) toothpaste

Marketed Stannous Fluoride Paste

Marketed Cavity Protection Toothpaste DRUG

Marketed sodium monofluorophosphate (0.76 %) toothpaste

Marketed Cavity Protection Toothpaste

Eligibility Criteria

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

You may qualify if:

• Be at least 18 years of age;
• Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
• Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;
• Have at least 16 gradable teeth;
• Agree to return for scheduled visits and follow the study procedures;
• Agree to refrain from use of any non-study oral hygiene products for the duration of the study;
• Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study;

You may not qualify if:

• Having taken antibiotic, anti-inflammatory, or anti-coagulant medications within 4 weeks of the Baseline Visit;
• Have any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease;
• Removable oral appliances;
• Fixed facial or lingual orthodontic appliances;
• Self-reported pregnancy or lactation;
• Any diseases or condition that might interfere with the safe participation in the study; and
• Inability to undergo study procedures.

Sponsors & Collaborators

• Procter and Gamble: lead

Study Sites (1)

University Health Resources Group

Whittier, California, 90604, United States

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2019
• First Posted: May 3, 2019
• Study Start: February 25, 2018
• Primary Completion: June 3, 2018
• Study Completion: June 3, 2018
• Last Updated: December 4, 2019

Record last verified: 2019-12

Locations

US (1)