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Completed

NCT Number: NCT05389124

Metagenome Resilience in Experimental Gingivitis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dental Clinical Research Facility

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Partial abstinence from oral hygiene

Behavioral

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

Primary outcomes

  1. Metagenomic sequence

    Time frame: Intervals up to 6 weeks

    Change from baseline

Secondary outcomes

  1. Metatranscriptomic sequence

    Time frame: Intervals up to 6 weeks

    Change from baseline

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

    Time frame: Intervals up to 6 weeks

    Change from baseline

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

    Time frame: Intervals up to 6 weeks

    Change from baseline

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

    Time frame: Intervals up to 6 weeks

    Change from baseline

Sponsors and collaborators

Lead sponsor

Newcastle University

Other

Collaborators

  • Newcastle-upon-Tyne Hospitals NHS Trust
  • Unilever SEAC

Registry information

Official study title

Functional Metagenomic Characterisation of Resilience in Experimental Gingivitis

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 25, 2022
Registry last updated
Jan 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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