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A Clinical Study to Evaluate the Efficacy of a Range of Dental/Denture Products for Improved Oral Health in Partial Denture Wearers

NCT04290624 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2023-11-18

Study results available
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Summary

The purpose of this study is to investigate the effectiveness of usage of a range of oral products (toothpaste, mouth rinse, denture cleanser) on the oral health of partial denture wearers compared to existing oral hygiene habits.The hypothesis is that there is no treatment difference in the oral health when using the range of products for 12 weeks compared to no intervention.

Conditions

  • Gingivitis

Interventions

OTHER

Experimental Dentifrice: Stannous Fluoride

Participants will be instructed to dose the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion containing 0.454% w/w Stannous fluoride for 2 minutes twice daily (morning and evening) for 12 weeks.

DEVICE

COREGA Denture Foaming Cleanser

Participant will clean their denture using 2 pumps of the denture cleansing foam and a denture cleaning brush for 90 timed seconds outside of the mouth twice daily (morning and evening) for 12 weeks.

OTHER

Mouth rinse: Sodium Fluoride

Participants will take 10 ml of the mouth rinse containing 90 ppm sodium fluoride and swished around the mouth for 1 minute twice daily (morning and evening) for 12 weeks.

Sponsors & Collaborators

  • HALEON

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-14
Primary Completion
2022-02-24
Completion
2022-02-24

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04290624 on ClinicalTrials.gov