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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

Gingivitis Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04290624
Study type Interventional
Source HALEON
Contact
Status Completed
Phase Phase 4
Start date October 14, 2020
Completion date February 24, 2022
View Details
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