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
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:
- 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.
- 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
Connect with a study center
Centre for Host-Microbiome Interactions, Guy's Hospital
London, SE1 9RT
United KingdomActive - Recruiting
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