A Clinical Study to Evaluate the Efficacy of a Range of Dental/Denture Products for Improved Oral… (NCT04290624) | Clinical Trial Compass
CompletedPhase 4
A Clinical Study to Evaluate the Efficacy of a Range of Dental/Denture Products for Improved Oral Health in Partial Denture Wearers
United Kingdom58 participantsStarted 2020-10-14
Plain-language summary
The purpose of this study is to investigate the effectiveness of usage of a range of oral products (toothpaste, mouth rinse, denture cleanser) on the oral health of partial denture wearers compared to existing oral hygiene habits.The hypothesis is that there is no treatment difference in the oral health when using the range of products for 12 weeks compared to no intervention.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. A participant with a minimum of 4 natural teeth in each arch.
✓. A participant with a minimum of 30 scorable surfaces for MGI (Modified Gingival Index), BI (Bleeding Index), OHI (oral hygiene index) and TPI (Turesky Plaque Index). (A scorable surface is defined as a surface that has at least 2/3 of the surface gradable for each clinical index. Third molars, orthodontically banded/bonded, fully crowned or extensively restored or grossly carious teeth are not included in the tooth or scorable surface count. Third molars can be included if, as a result tooth loss, they are functioning as second molars. Tooth surfaces with calculus deposits which, in the opinion of the clinical examiner, would interfere with the assessments of the selected clinical indices are also excluded.)
✓. A participant with a minimum of 2 scorable abutment teeth, defined as teeth proximal to the RPD (removable partial denture) or impinged by an RPD clasp or rest.
✓. A participant with generalized mild-moderate plaque-induced gingivitis present at the screening visit (in the opinion of the clinical examiner from a gross visual examination).
✓. A participant with a mean whole mouth BI \>= (greater than or equal to) 0.1 to =\< (less than or equal to) 1.3, a mean whole mouth MGI \>= 1.75 to =\< 2.30 and a mean overall TPI score \> (greater than) 1.5 at the Baseline visit.
✓. A participant who habitually wears one conventional removable partial denture constructed of acrylic or cobalt chrome which is acceptable according to the well made and well-fit assessments.
Exclusion criteria
✕. A participant who has taken or is currently taking antibiotics at the Screening visit or in the 14-day period prior to the Baseline visit or requiring antibiotic use prior to dental prophylaxis or other dental procedure.
✕. A participant who is currently taking, on a regular daily basis, an anti-inflammatory, anticoagulant or any other systemic medication (e.g. calcium channel blockers, aspirin therapy, ibuprofen, warfarin) or has a medical condition which, in the opinion of the Investigator, could affect the gingival condition.
✕. A participant who has used an antibacterial mouth rinse (e.g. chlorhexidine, Listerine), dentifrice (e.g. stannous fluoride) or use of any oral care product that, in the opinion of the investigator, could interfere with plaque accumulation or clinical measures within 28 days preceding the baseline visit.
✕. A participant with a condition or who is taking medication which, in the opinion of the investigator is causing xerostomia.
✕. A participant who, in the opinion of the investigator, has a periodontal condition that could be adversely affected by lack of immediate periodontal intervention.
✕. A participant who has received treatment for periodontal disease within 12 months of Screening and/or scaling or root surface debridement within 3 months of Screening, which, in the opinion of the Investigator, could compromise study outcomes or the oral health of the participant if they were to participate in the study.
✕. A participant who has numerous restorations in a poor state of repair.
✕. A participant with a severe oral condition (e.g. acute necrotizing ulcerative gingivitis, severe active caries) that could, in the opinion of the investigator, compromise study outcomes or the oral health of the participant if they were to participate in the study.