Individual Variability of Experimental Gingivitis Response

Launched by KING'S COLLEGE LONDON · Dec 9, 2022

Keywords

ClinConnect Summary

This clinical trial is looking to understand why some people develop gum disease, known as gingivitis, while others do not. Over a three-week period, participants will stop their usual oral hygiene routines to allow gingivitis to develop intentionally. After this period, they will resume tooth cleaning and researchers will assess their gum health and collect samples for further study. The goal is to uncover the genetic factors that may influence how each individual responds to changes in oral hygiene.

To be eligible for this study, participants should be between 18 and 35 years old, of Caucasian descent, and in good oral health, meaning they have no signs of severe gum disease. Participants must also be healthy overall, with no serious medical conditions, and should not have smoked in the past five years. During the study, participants can expect to undergo several assessments and provide samples while following the study's guidelines, which will help researchers gain valuable insights into gum disease.

Gender

ALL

Eligibility 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)