Metagenome Resilience in Experimental Gingivitis

Sponsor

Newcastle University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05389124

Collaborator

Unilever SEAC (Industry), Newcastle-upon-Tyne Hospitals NHS Trust (Other)

Enrollment

Location

9.3

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gingivitis Oral Disease	Behavioral: Partial abstinence from oral hygiene

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Functional Metagenomic Characterisation of Resilience in Experimental Gingivitis

Actual Study Start Date :

May 23, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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 One quadrant of the dentition will be protected from oral hygiene for 3 weeks.

Arm

Intervention/Treatment

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

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

Outcome Measures

Primary Outcome Measures

Metagenomic sequence [Intervals up to 6 weeks]
Change from baseline

Secondary Outcome Measures

Metatranscriptomic sequence [Intervals up to 6 weeks]
Change from baseline
Lobene Modified Gingival Index: Min 0 - Max 4; Worse- higher score indicates more gingival inflammation [Intervals up to 6 weeks]
Change from baseline
Plaque Index (Modified Quigley & Hein): Min 0 - Max 5; Worse - higher score indicates more plaque [Intervals up to 6 weeks]
Change from baseline
Bleeding Index (Bleeding on probing): Min 0 - Max 1; Worse- higher score indicates a bleeding site [Intervals up to 6 weeks]
Change from baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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