Gingivitis Oral Health
Conditions
Interventions
Subjects were randomly assigned to one of the two groups: the test toothpaste (Bexident® Encías Uso Diario, ISDIN, Barcelona, Spain), with CPC and cymenol as active ingredients
and the control toothpaste (Colgate Protection caries toothpaste, Colgate-Palmolive España S.A., Madrid, Spain), with fluoride and sodium monofluorophosphate as active ingredients. Patients were asked
Sponsors
Isdin (Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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).
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability: 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
| Measure | Time frame |
|---|---|
| Clinical outcome variables: Two researchers trained and calibrated, and the results of the calibration trials were assessed by means of the Kappa test (Fleiss & Chilton, 1983). They were both blinded to the treatment assignment and to the data from previous visits, and performed all the examinations of 30 patients each. Clinical examinations were performed in the following order: 1. The Gründemann index (GMSI) (Gründemann et al., 2000), modified by Koertge and Gunsolley (Koertge et al., 1993), in the upper and lower anterior teeth, buccal sites, by evaluating standardized clinical photographs. 2. The plaque index (PlI) of Quigley and Hein (Quigley & Hein, 1962), modified by Turesky et al. (Turesky et al., 1970), was assessed at six per tooth, using a revealing solution (Plac-Control®, Dentaid, Barcelona, Spain). 3. Bleeding on marginal probing (BOMP) (Lie et al., 1998; Van der Weijden et al., 1994), recording the presence or absence of bleeding within 30 seconds of probing on a 0-2 scale. 4. Bleeding on probing (BOP) (Ainamo & Bay, 1975) by dichotomous assessment of bleeding after gentle probing. Microbiological outcomes: Microbiological samples were collected at baseline and at week 6 in two sites, one in the upper jaw and one in the lower jaw, depending on the presence of bleeding at the baseline examination, but always at the same sites in both visits. Mesial of first molars (or alternatively, of the second molars or second premolars) was the preferred site for sampling. Sites were isolated with cotton rolls and gently dried with air. Two sterile paper points were consecutively inserted (medium size, Maillefer, Ballaigues, Switzerland) in each site. Each paper point was inserted into the sulcus/pocket as deep as possible and left in place for 10 seconds. A unique sample, with the four paper points, was available for each patient and visit. The paper points were transferred to a cryo-vial with a DNA/RNA Shield™ reagent, which lyses the samples, inactivates p | — |
Countries
Spain
Outcome results
None listed