Individual Variability of Experimental Gingivitis Response

Last updated: October 13, 2023
Sponsor: King's College London
Overall Status: Active - Recruiting

Phase

N/A

Condition

Periodontitis

Treatment

Temporary cessation of all oral hygiene

Clinical Study ID

NCT05656417
316902
  • Ages 18-35
  • All Genders
  • Accepts Healthy Volunteers

Study 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 cleaning is restored. Clinical assessments and biological samples will be taken during the course of the study for further analysis.

Eligibility Criteria

Inclusion

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 rarelysocially 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 consentand 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 priorto the end of the study
  • Participant in good periodontal health, based on:
  1. absence of interproximal probing pocket depths (PPD) and clinical attachmentlevel (CAL) > 3mm (with the exception of distal surfaces of third molars in thepresence 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

Exclusion Criteria:

  • Currently taking part in other clinical trials
  • Pregnant or breastfeeding women
  • Taking medications including systemic anti-inflammatory medication within 3 months ofthe study (NSAIDs, no more than once per week and not in the week before samplecollection, 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)

Study Design

Total Participants: 56
Treatment Group(s): 1
Primary Treatment: Temporary cessation of all oral hygiene
Phase:
Study Start date:
January 19, 2023
Estimated Completion Date:
July 31, 2025

Study 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.

Connect with a study center

  • Centre for Host-Microbiome Interactions, Guy's Hospital

    London, SE1 9RT
    United Kingdom

    Active - Recruiting

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