NCT05389124

Metagenome Resilience in Experimental Gingivitis

Functional Metagenomic Characterisation of Resilience in Experimental Gingivitis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Newcastle University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study aims to identify new biomarkers that indicate the resilience of individuals to developing oral disease. An 'experimental gingivitis' model will be employed in which subjects will refrain from oral hygiene in one quadrant of their mouths for 3 weeks, and will then restore oral hygiene. Gum inflammation will be monitored by clinical measures throughout the trial and samples will be collected for analysis of microbial DNA and RNA.

Detailed description

This project will employ an extended experimental gingivitis model to monitor changes in the oral metagenome and metatranscriptome during progression to gingivitis and recovery to oral health. The study will employ a 'split-mouth' design whereby one half of each individual's mouth is protected from oral hygiene while the other half acts as an internal control. Oral health status will be monitored through clinical measurements of dental plaque accumulation and gingival index. Plaque samples will be collected for DNA (metagenome) and RNA (metatranscriptome) sequencing. Using statistical modelling, genes and functional pathways will be identified that associate with resistance and resilience to gingivitis.

Conditions

• Gingivitis
• Oral Disease

Interventions

Type	Name	Description
BEHAVIORAL	Partial abstinence from oral hygiene	One quadrant of the dentition will be protected from oral hygiene for 3 weeks.

Timeline

• Start date: 2022-05-23
• Primary completion: 2022-12-09
• Completion: 2022-12-09
• First posted: 2022-05-25
• Last updated: 2023-01-30

Locations

1 site across 1 country: United Kingdom