GingivitisNCT05656417
Individual Variability of Experimental Gingivitis Response
An observational study of Gingivitis and Oral Disease, run by King's College London at 1 site in United Kingdom.
Trial summary
The study aims to investigate the genetic cause of the variability between individuals seen in the development of the gum disease, gingivitis. This will be carried out through a 3 week programme where all oral hygiene is ceased, allowing 'experimental gingivitis' to develop, followed by a period of recovery when tooth… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Oral Disease
- What is being tested?
- Temporary cessation of all oral hygiene
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Jan 2023to 20 Mar 2025
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Gingivally healthy young adults
Who may be able to join
- Age 18 to 35
- Caucasian
- No history of periodontitis/periodontal treatment (based on self-reported history)
- Medical history clear of cardiovascular disease, diabetes, cerebrovascular disease, kidney or liver disease, cancer, HIV, Tuberculosis and Hepatitis C (self-reported)
- Never smoker, e-cigarettes or nicotine gum use (self-reported). Individuals who rarely socially smoked more than 5 years ago would be permitted to participate.
- Minimum of 24 teeth present
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- Be willing and competent (verbally and cognitively) to give written informed consent and complete a medical history form
- Be willing and physically able to carry out all study procedures
- Not have had a scale and prophylaxis in the previous month or have one scheduled prior to the end of the study
- Participant in good periodontal health, based on:
- absence of interproximal probing pocket depths (PPD) and clinical attachment level (CAL) > 3mm (with the exception of distal surfaces of third molars in the presence of impacted third molars) at the screening visit.
- bleeding on probing (BOP) < 30% at the Screening visit and BOP <10% at Day -7.
Who cannot join
- Currently taking part in other clinical trials
- Pregnant or breastfeeding women
- Taking medications including systemic anti-inflammatory medication within 3 months of the study (NSAIDs, no more than once per week and not in the week before sample collection, is permitted)
- Systemic antibiotic intake within 6 months
- Psychiatric conditions affecting participation in the study
- The participant is also a member of staff who is part of the study team
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- Current orthodontic treatment
- Regular consumption of alcohol exceeding the government recommended levels
- Denture wearer/presence of dental implants/bridges
- Have oral piercings
- Obvious signs of untreated caries
- Taking dietary supplements (e.g. multivitamins; antioxidants; fish oils)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Host-Microbiome Interactions, Guy's Hospital
London, SE1 9RT
About this study
Official title: Individual Variability of Experimental Gingivitis Response: a Parallel-group Cohort Study
The study aims to investigate the genetic cause of the variability between individuals seen in the development of the gum disease, gingivitis. This will be carried out through a 3 week programme where all oral hygiene is ceased, allowing 'experimental gingivitis' to develop, followed by a period of recovery when tooth cleaning is restored. Clinical assessments and biological samples will be taken during the course of the study for further analysis.
Read the detailed description
The purpose of the project is to investigate the factors which influence the oral disease, gingivitis. Gingivitis is the inflammation (swelling, redness, pain) of the gums, caused by the build-up of bacteria in the mouth. Research shows that the severity, extent and rate of development of gingivitis varies considerably between individuals. The aim of this project therefore is to investigate if an individual's DNA contributes to this range in outcomes and what impact it has on the human and bacterial cells in the mouth. This will be investigated through a period where all tooth brushing and oral hygiene will cease, and the changes in the mouth measured as the temporary 'experimental gingivitis' develops. Clinical measurements will include plaque build-up, levels of inflammation and bleeding scores, while samples of blood, saliva and plaque will be used to quantify changes in inflammatory markers and bacterial community composition.
- Conditions
- Gingivitis, Oral Disease
- Being tested
- Temporary cessation of all oral hygiene
- Keywords
- Experimental gingivitis, Periodontal disease, Gingival disease, Infectogenomics, Oral health, Dental plaque
- Medical subject headings
- Gingivitis, Mouth Diseases, Periodontal Diseases, Gingival Diseases, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary cessation of all oral hygieneBehavioural
Also called Experimental gingivitis
Participants will refrain from all oral hygiene for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Haplotype 1 | Participants will attend a screening visit where they will provide a saliva sample for DNA sequencing. Participants will then be separated into two groups based on their gene profile. Participants in Group 1 will have a specific haplotype of the gene of interest. The groups will undergo a 2-week period of thorough oral hygiene and prophylactic treatment to achieve excellent gingival health. Participants in both groups will then cease all oral hygiene for a period of 3 weeks, where a state of gingivitis will develop. At the end of the 3 weeks, normal oral hygiene will be reinstated and prophylactic treatment offered as required for a further 2 weeks. Receives: Behavioral: Temporary cessation of all oral hygiene | |
| Haplotype 2 | Participants will attend a screening visit where they will provide a saliva sample for DNA sequencing. Participants will then be separated into two groups based on their gene profile. Group 2 will comprise of participants who possess a second distinct haplotype in the same gene of interest as Group 1. This group will undergo the same study procedures as Haplotype Group 1. Receives: Behavioral: Temporary cessation of all oral hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Löe-Silness Gingival Index: Min 0 - Max 3; Higher score indicates more gingival inflammation and a worse outcome.
Change from baseline.
Measured: Intervals over 6 weeks.
Secondary outcomes (4)
Silness-Löe Plaque Index: Min 0 - Max 3; Higher score indicates more plaque accumulation and a worse outcome.
Change from baseline.
Measured: Intervals over 6 weeks.
Bleeding on Probing: Min 0 - Max 1; Higher score indicates bleeding at the gingival site and a worse outcome.
Change from baseline.
Measured: Intervals over 6 weeks.
Microbial dysbiosis (detection and counts of subgingival microbes).
Change from baseline.
Measured: Intervals over 6 weeks.
Inflammatory markers (e.g. matrix metalloproteinase-8 and IL-1β) in blood, gingival crevicular fluid and saliva samples: Higher levels indicate a greater degree of gingival inflammation.
Change from baseline. Measured by enzyme-linked immunosorbent assay (units: ng/mL) in each sample type.
Measured: Intervals over 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start19 Jan 2023
- Primary completion20 Mar 2025
- Study completion20 Mar 2025
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Biotechnology and Biological Sciences Research Council, Unilever R&D
- Responsible party
- Sponsor
- Investigators
- Luigi Nibali, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656417
- Sponsor's protocol ID
- 316902
- Status last verified
- Aug 2026
- First submitted
- 25 Nov 2022
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A data sharing agreement is in place with a funder of the project, Unilever plc. Anonymised participant demographics will be linked to the data, such as year of birth and sex.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Variability of Experimental Gingivitis Response: a Parallel-group Cohort Study
- ClinicalTrials.gov ID
- NCT05656417
- Acronym / sponsor ID
- 316902
- Conditions
- Gingivitis, Oral Disease
- Keywords
- Experimental gingivitis, Periodontal disease, Gingival disease, Infectogenomics, Oral health, Dental plaque
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Biotechnology and Biological Sciences Research Council, Unilever R&D
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 19 Dec 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.
The study aims to investigate the genetic cause of the variability between individuals seen in the development of the gum disease, gingivitis. This will be carried out through a 3 week programme where all oral hygiene is ceased, allowing 'experimental gingivitis' to develop, followed by a period of recovery when tooth cleaning is restored. Clinical assessments and biological samples will be taken during the course of the study for further analysis.
Detailed description
The purpose of the project is to investigate the factors which influence the oral disease, gingivitis. Gingivitis is the inflammation (swelling, redness, pain) of the gums, caused by the build-up of bacteria in the mouth. Research shows that the severity, extent and rate of development of gingivitis varies considerably between individuals. The aim of this project therefore is to investigate if an individual's DNA contributes to this range in outcomes and what impact it has on the human and bacterial cells in the mouth. This will be investigated through a period where all tooth brushing and oral hygiene will cease, and the changes in the mouth measured as the temporary 'experimental gingivitis' develops. Clinical measurements will include plaque build-up, levels of inflammation and bleeding scores, while samples of blood, saliva and plaque will be used to quantify changes in inflammatory markers and bacterial community composition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Haplotype 1 | – | Behavioral: Temporary cessation of all oral hygieneParticipants will attend a screening visit where they will provide a saliva sample for DNA sequencing. Participants will then be separated into two groups based on their gene profile. Participants in Group 1 will have a specific haplotype of the gene of interest. The groups will undergo a 2-week period of thorough oral hygiene and prophylactic treatment to achieve excellent gingival health. Participants in both groups will then cease all oral hygiene for a period of 3 weeks, where a state of gingivitis will develop. At the end of the 3 weeks, normal oral hygiene will be reinstated and prophylactic treatment offered as required for a further 2 weeks. |
| Haplotype 2 | – | Behavioral: Temporary cessation of all oral hygieneParticipants will attend a screening visit where they will provide a saliva sample for DNA sequencing. Participants will then be separated into two groups based on their gene profile. Group 2 will comprise of participants who possess a second distinct haplotype in the same gene of interest as Group 1. This group will undergo the same study procedures as Haplotype Group 1. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Gingivally healthy young adults
Key inclusion criteria (12 listed)
- Age 18 to 35
- Caucasian
- No history of periodontitis/periodontal treatment (based on self-reported history)
- Medical history clear of cardiovascular disease, diabetes, cerebrovascular disease, kidney or liver disease, cancer, HIV, Tuberculosis and Hepatitis C (self-reported)
- Never smoker, e-cigarettes or nicotine gum use (self-reported). Individuals who rarely socially smoked more than 5 years ago would be permitted to participate.
Key exclusion criteria (12 listed)
- Currently taking part in other clinical trials
- Pregnant or breastfeeding women
- Taking medications including systemic anti-inflammatory medication within 3 months of the study (NSAIDs, no more than once per week and not in the week before sample collection, is permitted)
- Systemic antibiotic intake within 6 months
- Psychiatric conditions affecting participation in the study
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 |
|---|---|---|
| Temporary cessation of all oral hygieneAlso: Experimental gingivitisParticipants will refrain from all oral hygiene for 3 weeks. | Behavioural | Haplotype 1, Haplotype 2 |
Primary outcome
Löe-Silness Gingival Index: Min 0 - Max 3; Higher score indicates more gingival inflammation and a worse outcome.
Time frame: Intervals over 6 weeks.
Change from baseline.
4 secondary outcomes
Silness-Löe Plaque Index: Min 0 - Max 3; Higher score indicates more plaque accumulation and a worse outcome.
Time frame: Intervals over 6 weeks.
Bleeding on Probing: Min 0 - Max 1; Higher score indicates bleeding at the gingival site and a worse outcome.
Time frame: Intervals over 6 weeks.
Microbial dysbiosis (detection and counts of subgingival microbes).
Time frame: Intervals over 6 weeks.
Inflammatory markers (e.g. matrix metalloproteinase-8 and IL-1β) in blood, gingival crevicular fluid and saliva samples: Higher levels indicate a greater degree of gingival inflammation.
Time frame: Intervals over 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 7 Aug 2026.
- Individual participant dataSharing planned: No. A data sharing agreement is in place with a funder of the project, Unilever plc. Anonymised participant demographics will be linked to the data, such as year of birth and sex.
Related trials for Gingivitis
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingObservational study
Circadian Clock Proteins in Gingival Crevicular Fluid of Individuals With and Without Circadian Rhythm Disruption
Gingivitis, Circadian Rhythm Disruption
Active, not recruitingObservational study
Comparison of Saliva Characteristics and Oral Health in Pregnant and Non-pregnant Women
Plaque Induced Gingivitis
Not yet recruiting
Effectiveness of Oil Pulling Using Oils in Comparison With Mouthwash for Gingivitis
Gingivitis
Not yet recruitingObservational study
Salivary and GCF Biomarkers in Periodontal Health, Gingivitis and Periodontitis
Periodontal Health, Gingivitis
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.
Luigi Nibali, PhD principal investigator
King's College London
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 King's College London 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 12 inclusion and 12 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 7 Aug 2026. 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?
Löe-Silness Gingival Index: Min 0 - Max 3; Higher score indicates more gingival inflammation and a worse outcome. (time frame: Intervals over 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 7 Aug 2026.