Metagenome Resilience in Experimental Gingivitis

NCT05389124 | Completed

• 1 other identifier: NU008913
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingivitis; Oral Disease

Keywords

Experimental gingivitis; Dental plaque; Metagenome; Oral health

Outcome Measures

Primary Outcomes (1)

• Metagenomic sequence

  Change from baseline

  Intervals up to 6 weeks

Secondary Outcomes (4)

• Metatranscriptomic sequence

  Intervals up to 6 weeks

• Lobene Modified Gingival Index: Min 0 - Max 4; Worse- higher score indicates more gingival inflammation

  Intervals up to 6 weeks

• Plaque Index (Modified Quigley & Hein): Min 0 - Max 5; Worse - higher score indicates more plaque

  Intervals up to 6 weeks

• Bleeding Index (Bleeding on probing): Min 0 - Max 1; Worse- higher score indicates a bleeding site

  Intervals up to 6 weeks

Study Arms (1)

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.

Behavioral: Partial abstinence from oral hygiene

Interventions

Partial abstinence from oral hygiene BEHAVIORAL

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

Experimental gingivitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Gingivally healthy participants

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Newcastle University: lead
• Unilever SEAC: collaborator
• Newcastle-upon-Tyne Hospitals NHS Trust: collaborator

Study Sites (1)

Dental Clinical Research Facility

Newcastle upon Tyne, Tyne and Wear, NE2 4BW, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Gingival margin plaque.

MeSH Terms

Conditions

Gingivitis; Mouth Diseases; Dental Plaque

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Stomatognathic Diseases; Dental Deposits; Tooth Diseases

Study Officials

• Nicholas S Jakubovics, PhD

  Newcastle University

  STUDY DIRECTOR

• Richard Holliday, PhD

  Newcastle University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 25, 2022
• Study Start: May 23, 2022
• Primary Completion: December 9, 2022
• Study Completion: December 9, 2022
• Last Updated: January 30, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)