Testing toothpaste with cetyl pyridinium chloride and cymenol: Is it safe, effective, and what do patients think?
- Conditions
- GingivitisOral Health
- Registration Number
- ISRCTN17497809
- Lead Sponsor
- Isdin (Spain)
- Brief Summary
2023 Results article in https://doi.org/10.3390/app14010105 (added 27/12/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 55
1. Over 18 years of age.
2. Systemically healthy, defined according to the criteria of the American Society of Anesthesiologists (ASA) (Doyle et al., 2021), as ASA type I or II (see also exclusion criteria).
3. Presence of at least three evaluable teeth in each quadrant.
4. Moderate gingival inflammation (= 40% bleeding on marginal probing, BOMP) (Van der Weijden et al., 1994) and Turesky plaque index = 1.5 (Turesky et al., 1970). Likewise, the criteria of the World Workshop and the bleeding on probing (BOP) (Ainamo & Bay, 1975), and at least 10% of BOP (Chapple et al., 2015) were considered.
5. Absence of probing depths (PD) = 5 mm,
6. No fixed orthodontic treatments or removable prostheses.
7. Brushed their teeth regularly (at least twice a day).
1. Untreated or uncontrolled periodontitis.
2. Regularly users of mouthwashes during the month prior to the screening.
3. Antibiotics intake within the previous month.
4. Pregnant women.
5. Any chronic disease or medication that may influence gingival inflammation.
6. Conditions requiring antibiotic coverage.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability:<br>Each participant was interviewed regarding adverse events at each visit. Visual soft- and hard-tissue examinations of the oral cavity were performed at every visit to assess the safety of the products. Spontaneous reports of adverse events were also recorded.
- Secondary Outcome Measures
Name Time Method