Investigating individual differences in gum disease development
Individual Variability of Experimental Gingivitis Response: a Parallel-group Cohort Study
This study is testing how our genes might affect the way gum disease develops in different people by looking at changes in their mouths after a short break from brushing and flossing.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 56 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | All |
| Sponsor | King's College London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT05656417 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the genetic factors that contribute to the variability in the development of gingivitis among individuals. Participants will undergo a three-week period of no oral hygiene to allow 'experimental gingivitis' to develop, followed by a recovery phase where normal oral care is resumed. Clinical assessments will be conducted to measure plaque accumulation, inflammation levels, and bleeding scores, while biological samples such as blood, saliva, and plaque will be collected for further analysis of inflammatory markers and bacterial composition. The goal is to understand how individual DNA influences the severity and progression of gingivitis.
Who should consider this trial
Good fit: Ideal candidates are healthy Caucasian individuals aged 18 to 35 with no history of periodontal disease.
Not a fit: Patients with a history of periodontal treatment or significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized approaches in preventing and treating gingivitis based on genetic predispositions.
How similar studies have performed: While studies on gingivitis exist, this specific approach focusing on genetic variability in response to experimental gingivitis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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: 1. 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. 2. bleeding on probing (BOP) \< 30% at the Screening visit and BOP \<10% at Day -7. Exclusion Criteria: * 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 * 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)
Where this trial is running
London
- Centre for Host-Microbiome Interactions, Guy's Hospital — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Luigi Nibali, PhD — King's College London
- Study coordinator: Luigi Nibali, PhD
- Email: luigi.nibali@kcl.ac.uk
- Phone: 02071888801
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.