Metagenome Resilience in Experimental Gingivitis

NCT ID: NCT05389124

Last Updated: 2023-01-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-23
• Study Completion Date: 2022-12-09

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 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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Partial abstinence from oral hygiene

Intervention Type: BEHAVIORAL

One quadrant of the dentition will be protected from oral hygiene for 3 weeks.

Interventions

Partial abstinence from oral hygiene

One quadrant of the dentition will be protected from oral hygiene for 3 weeks.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Unilever SEAC

INDUSTRY

Sponsor Role: collaborator

Newcastle-upon-Tyne Hospitals NHS Trust

OTHER

Sponsor Role: collaborator

Newcastle University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicholas S Jakubovics, PhD

Role: STUDY_DIRECTOR

Newcastle University

Richard Holliday, PhD

Role: PRINCIPAL_INVESTIGATOR

Newcastle University

Locations

Dental Clinical Research Facility

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Countries

United Kingdom

Other Identifiers

NU008913

Identifier Type: -

Identifier Source: org_study_id