Gingivitis Oral Health Gingivitis and periodontal diseases
Conditions
Interventions
This is a double-blind controlled intervention clinical trial with 5 weeks follow-up aiming to evaluate and compare the acute and reversible changes in the gingival tissue, plaque accumulation and hos
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 – 60 2. Non-smoker 3. Absence of probing pocket depth =5 mm in more than 4 sites (excluding wisdom teeth) 4. No history of previous periodontitis and have at least 20 teeth including natural uncrowned maxillary incisors (excluding wisdom teeth) 5. Have voluntarily signed the informed consent
Exclusion criteria
Exclusion criteria: 1. Presence of systemic diseases (e.g., diabetes mellitus or cardiovascular, kidney, liver or lung disease) 2. Pregnant or breastfeeding 3. History of drug abuse 4. Using any medication to treat a chronic disease 5. Regular use of analgesic or antibiotics within 1 month before entering the study 6. Have untreated gross carious lesions and/or insufficient restorations 7. Have implants, orthodontic retainers, crowns/bridges or missing teeth/partial dentures in the maxillary arch 8. History of mouth breathing 9. Allergic to ingredients of study products or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study 10. Concurrent participation in other clinical studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Full mouth bleeding, recorded as the percentages of total surfaces (6 aspects per tooth) which revealed bleeding within 30 seconds following probing (bleeding on probing). A binary score will be assigned to each surface (1 for bleeding present, 0 for absent). Evaluated at baseline, 3 weeks and 5 weeks follow up. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Gingival response, assessed using: 1.1. Gingival Index 1.2. Probing pocket depth, gingival recession and clinical attachment levels 1.3. Laser Doppler High-resolution blood flow images of the gingival microcirculation 1.4. Optical Coherence Tomography (OCT) analysis of soft tissue volume changes 1.5. Microvascular imaging with Capiscope camera 2. Humoral and cellular gingival response to plaque accumulation, assayed in crevicular fluid (GCF) by proteomic analysis 3. Dental plaque, assessed using: 3.1. Clinical assessment visual indexes (modified Quigley-Heine plaque index, O’Leary index) 3.2. Instrumental (by Sopro fluorescence camera and OCT) 3.3. Microbiological supra-gingival sample collection, storage and processing for evaluation of shifts in ecology 4. Host response, assessed using: 4.1. Collection of unstimulated saliva and stimulated within a set interval, and analysis in saliva of bacterial and immune products 4.2. Plasma samples collection and analysis for host response (inflammatory/immune) and intracellular oxidative stress analysis 5. Vascular response, assessed using endothelial function of brachial artery, pulse wave velocity 6. Diet changes, assessed using a food diary Measured at baseline (all secondary outcomes), 1 week (OCT, Laser Doppler, modified Quigley-Heine plaque index, O’Leary index, Sopro fluorescence camera), 2 weeks (OCT, Laser Doppler, modified Quigley-Heine plaque index, O’Leary index, Sopro fluorescence camera), 3 weeks (all secondary outcomes), 4 weeks (OCT, Laser Doppler, modified Quigley-Heine plaque index, O’Leary index, Sopro fluorescence camera), 5 weeks (all secondary outcomes except food diary) follow-up. | — |
Countries
United Kingdom
Outcome results
None listed