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| Name | Class |
|---|---|
| Unilever SEAC | INDUSTRY |
| Newcastle-upon-Tyne Hospitals NHS Trust | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental gingivitis | Group will wear a splint during oral hygiene to cover one quadrant of their dentition. They will develop gingivitis over 3 weeks. They will practise normal oral hygiene in the rest of their mouth (with minor restrictions, e.g. no mouthwash) and one other quadrant will act as an internal control for the gingivitis. After 3 weeks, normal oral hygiene will be restored throughout the mouth and subjects will continue to be monitored for a further 3 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Partial abstinence from oral hygiene | Behavioral | One quadrant of the dentition will be protected from oral hygiene for 3 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Metagenomic sequence | Change from baseline | Intervals up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Metatranscriptomic sequence | Change from baseline | Intervals up to 6 weeks |
| Lobene Modified Gingival Index: Min 0 - Max 4; Worse- higher score indicates more gingival inflammation | Change from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Gingivally healthy participants
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas S Jakubovics, PhD | Newcastle University | Study Director |
| Richard Holliday, PhD | Newcastle University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dental Clinical Research Facility | Newcastle upon Tyne | Tyne and Wear | NE2 4BW | United Kingdom |
Anonymised participant demographics will be linked to the data: Year of birth, sex, ethnicity.
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| D009059 | Mouth Diseases |
| D003773 | Dental Plaque |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009057 | Stomatognathic Diseases |
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Gingival margin plaque.
| Intervals up to 6 weeks |
| Plaque Index (Modified Quigley & Hein): Min 0 - Max 5; Worse - higher score indicates more plaque | Change from baseline | Intervals up to 6 weeks |
| Bleeding Index (Bleeding on probing): Min 0 - Max 1; Worse- higher score indicates a bleeding site | Change from baseline | Intervals up to 6 weeks |
| D003741 |
| Dental Deposits |
| D014076 | Tooth Diseases |