GingivitisNCT05389124
Metagenome Resilience in Experimental Gingivitis
An observational study of Gingivitis and Oral Disease, run by Newcastle University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Oral Disease
- What is being tested?
- Partial abstinence from oral hygiene
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 May 2022to 9 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Gingivally healthy participants
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Dental Clinical Research Facility
Newcastle upon Tyne, Tyne and Wear, NE2 4BW
About this study
Official title: Functional Metagenomic Characterisation of 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.
Read the 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
- Being tested
- Partial abstinence from oral hygiene
- Keywords
- Experimental gingivitis, Dental plaque, Metagenome, Oral health
- Medical subject headings
- Gingivitis, Mouth Diseases, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial abstinence from oral hygieneBehavioural
One quadrant of the dentition will be protected from oral hygiene for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Partial abstinence from oral hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metagenomic sequence
Change from baseline
Measured: Intervals up to 6 weeks
Secondary outcomes (4)
Metatranscriptomic sequence
Change from baseline
Measured: Intervals up to 6 weeks
Lobene Modified Gingival Index: Min 0 - Max 4; Worse- higher score indicates more gingival inflammation
Change from baseline
Measured: Intervals up to 6 weeks
Plaque Index (Modified Quigley & Hein): Min 0 - Max 5; Worse - higher score indicates more plaque
Change from baseline
Measured: Intervals up to 6 weeks
Bleeding Index (Bleeding on probing): Min 0 - Max 1; Worse- higher score indicates a bleeding site
Change from baseline
Measured: Intervals up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start23 May 2022
- Primary completion9 Dec 2022
- Study completion9 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle University
- Sponsor type
- University, hospital or other
- Collaborators
- Unilever SEAC, Newcastle-upon-Tyne Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Nicholas S Jakubovics, PhD, Study director, Newcastle UniversityRichard Holliday, PhD, Principal investigator, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389124
- Sponsor's protocol ID
- NU008913
- Status last verified
- May 2022
- First submitted
- 18 May 2022
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymised participant demographics will be linked to the data: Year of birth, sex, ethnicity.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Metagenomic Characterisation of Resilience in Experimental Gingivitis
- ClinicalTrials.gov ID
- NCT05389124
- Acronym / sponsor ID
- NU008913
- Conditions
- Gingivitis, Oral Disease
- Keywords
- Experimental gingivitis, Dental plaque, Metagenome, Oral health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Newcastle UniversityUniversity, hospital or other
- Collaborators
- Unilever SEAC, Newcastle-upon-Tyne Hospitals NHS Trust
- Study start
- 23 May 2022 (actual)
- Primary completion
- 9 Dec 2022 (actual)
- Study completion
- 9 Dec 2022 (actual)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental gingivitis | – | Behavioral: Partial abstinence from oral hygieneGroup 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Gingivally healthy participants
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partial abstinence from oral hygieneOne quadrant of the dentition will be protected from oral hygiene for 3 weeks. | Behavioural | Experimental gingivitis |
Primary outcome
Metagenomic sequence
Time frame: Intervals up to 6 weeks
Change from baseline
4 secondary outcomes
Metatranscriptomic sequence
Time frame: Intervals up to 6 weeks
Lobene Modified Gingival Index: Min 0 - Max 4; Worse- higher score indicates more gingival inflammation
Time frame: Intervals up to 6 weeks
Plaque Index (Modified Quigley & Hein): Min 0 - Max 5; Worse - higher score indicates more plaque
Time frame: Intervals up to 6 weeks
Bleeding Index (Bleeding on probing): Min 0 - Max 1; Worse- higher score indicates a bleeding site
Time frame: Intervals up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Individual participant dataSharing planned: No. Anonymised participant demographics will be linked to the data: Year of birth, sex, ethnicity.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas S Jakubovics, PhD study director
Newcastle University
Richard Holliday, PhD principal investigator
Newcastle University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gingivitis and Oral Disease, run by Newcastle University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metagenomic sequence (time frame: Intervals up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023.