NCT04290624

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

A Randomized, Controlled Clinical Study to Evaluate the Efficacy of a Range of Dental/Denture Products for Improved Oral Health, Compared to Existing Oral Hygiene, in a Population of Partial Denture Wearers With Generalized Mild-moderate Plaque-induced Gingivitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: HALEON · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study is a single-center, single-blind (to the examiner(s) performing the plaque, gingivitis, denture cleanliness and oral hygiene assessments), randomized, stratified (by denture material type and baseline mean overall modified gingival index \[MGI\] score), two-treatment, parallel group, 12 week clinical study in generally healthy, adult participants with at least one conventional removable partial denture (RPD) and generalized, mild-moderate, plaque-induced gingivitis (as determined by clinical examiner) and greater than or equal to \>=4 natural teeth in each arch that meet all study criteria at both the Screening and Baseline visits (including \>= 30 evaluable surfaces for clinical evaluation of gingivitis and plaque). The study will examine the effects of twice daily use of a range of dental/denture products (comprising use of a dentifrice, a mouthrinse and a denture cleanser) compared to no intervention (participants who continue with their existing oral hygiene habits). There will be four visits to the study site: screening, baseline (when participants are randomized), and after 6- and 12 weeks use of the range of dental/denture products.

Conditions

• Gingivitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-10-14
• Primary completion: 2022-02-24
• Completion: 2022-02-24
• First posted: 2020-03-02
• Last updated: 2023-11-18
• Results posted: 2023-11-18

Locations

1 site across 1 country: United Kingdom