Status:
COMPLETED
Metagenome Resilience in Experimental Gingivitis
Lead Sponsor:
Newcastle University
Collaborating Sponsors:
Unilever SEAC
Newcastle-upon-Tyne Hospitals NHS Trust
Conditions:
Gingivitis
Oral Disease
Eligibility:
All Genders
18+ years
Brief 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 fr...
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 stu...
Eligibility Criteria
Inclusion
- have read, understood and signed an informed consent form
- be adults of age 18 years or over
- have a minimum of 20 natural teeth (excluding third molars)
- be willing and able to comply with study procedures
- be a non-smoker and non-user of e-cigarettes or other oral intake nicotine replacement therapy (or have quit smoking/e-cigarettes/oral intake nicotine replacement therapy at least 2 years previously)
- healthy participants: good oral (no sites with interproximal attachment loss, GI ≥ 2.0 in ≤ 10% sites, %BOP scores ≤ 10%) and good general health.
- Covid-19 negative by LFT and fully vaccinated
Exclusion
- infectious or systemic diseases that may be unduly affected by participation in this study
- extensive crown or bridge work and/or rampant decay at the discretion of the examiner
- wear removable partial dentures, a fixed/removable orthodontic appliance
- diabetes
- history of xerostomia, salivary gland disease, head and neck radiotherapy, Sjögren's syndrome, mucocutaneous disorders of the oral cavity, vesicobullous disorders of the oral cavity
- smoking or use of e-cigarettes within the last 2 years
- current use of prescription or over-the-counter medications that could affect salivary flow, at the discretion of the examiner
- lack of capacity to be able to consent to the research project and/or inability to follow study instructions
- pregnant by medical history or nursing
- currently undergoing or requiring extensive dental, orthodontic or implant treatment, or treatment for peri-implantitis
- treatment with antibiotics for any medical or dental condition within 4 weeks prior to enrolment
- scale and polish within 4 weeks prior to enrolment
- long term use of antibiotics or non-steroidal anti-inflammatory drugs (prophylactic low dose aspirin is permitted though)
- evidence of drug induced gingival overgrowth
- participation in a dental research study within the previous 20 days.
- Unilever personnel and personnel in the University department performing the study
Key Trial Info
Start Date :
May 23 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 9 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05389124
Start Date
May 23 2022
End Date
December 9 2022
Last Update
January 30 2023
Active Locations (1)
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1
Dental Clinical Research Facility
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE2 4BW