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| Name | Class |
|---|---|
| Unilever R&D | INDUSTRY |
| Guy's and St Thomas' NHS Foundation Trust | OTHER |
| Biotechnology and Biological Sciences Research Council | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temporary cessation of all oral hygiene | Behavioral | Participants will refrain from all oral hygiene for 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Löe-Silness Gingival Index: Min 0 - Max 3; Higher score indicates more gingival inflammation and a worse outcome. | Change from baseline. | Intervals over 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Silness-Löe Plaque Index: Min 0 - Max 3; Higher score indicates more plaque accumulation and a worse outcome. | Change from baseline. | Intervals over 6 weeks. |
| Bleeding on Probing: Min 0 - Max 1; Higher score indicates bleeding at the gingival site and a worse outcome. |
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Inclusion Criteria:
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
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:
Exclusion Criteria:
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Gingivally healthy young adults
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luigi Nibali, PhD | Contact | 02071888801 | 57284 | luigi.nibali@kcl.ac.uk |
| Dewi R Owen, BSc | Contact | 020 7188 8094 | dewi.owen@kcl.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Luigi Nibali, PhD | King's College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Host-Microbiome Interactions, Guy's Hospital | Recruiting | London | SE1 9RT | United Kingdom |
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.
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| D009059 | Mouth Diseases |
| D010510 | Periodontal Diseases |
| D005882 | Gingival Diseases |
| D003773 | Dental Plaque |
| ID | Term |
|---|---|
| D007239 | Infections |
| D009057 | Stomatognathic Diseases |
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
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Samples will include saliva, whole blood, serum, sub- and supra- gingival plaque, gingival crevicular fluid.
Change from baseline. |
| Intervals over 6 weeks. |
| Microbial dysbiosis (detection and counts of subgingival microbes). | Change from baseline. | 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. | Intervals over 6 weeks. |