NCT05656417

Individual Variability of Experimental Gingivitis Response

Individual Variability of Experimental Gingivitis Response: a Parallel-group Cohort Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 56 (estimated)
• Sponsor: King's College London · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

The study aims to investigate the genetic cause of the variability between individuals seen in the development of the gum disease, gingivitis. This will be carried out through a 3 week programme where all oral hygiene is ceased, allowing 'experimental gingivitis' to develop, followed by a period of recovery when tooth cleaning is restored. Clinical assessments and biological samples will be taken during the course of the study for further analysis.

Detailed description

The purpose of the project is to investigate the factors which influence the oral disease, gingivitis. Gingivitis is the inflammation (swelling, redness, pain) of the gums, caused by the build-up of bacteria in the mouth. Research shows that the severity, extent and rate of development of gingivitis varies considerably between individuals. The aim of this project therefore is to investigate if an individual's DNA contributes to this range in outcomes and what impact it has on the human and bacterial cells in the mouth. This will be investigated through a period where all tooth brushing and oral hygiene will cease, and the changes in the mouth measured as the temporary 'experimental gingivitis' develops. Clinical measurements will include plaque build-up, levels of inflammation and bleeding scores, while samples of blood, saliva and plaque will be used to quantify changes in inflammatory markers and bacterial community composition.

Conditions

• Gingivitis
• Oral Disease

Interventions

Type	Name	Description
BEHAVIORAL	Temporary cessation of all oral hygiene	Participants will refrain from all oral hygiene for 3 weeks.

Timeline

• Start date: 2023-01-19
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2022-12-19
• Last updated: 2023-10-16

Locations

1 site across 1 country: United Kingdom