Gingivitis
Conditions
Interventions
At session 1:
Subjects have to rinse 3 times a day during 3 days with CPC-mouthrinse, Hexitine mouthrinse or a placebo mouthrinse.
The above mentioned procedure will be repeated also at session 2
Sponsors
Dentaid International
Eligibility
Inclusion criteria
Inclusion criteria: 1. Be between the ages of 18 and 70 2. Be in good general health as determined by the investigator/designee based on a review of the medical history/update 3. Possess at least 5 evaluable teeth in each quadrant in the lower jaw
Exclusion criteria
Exclusion criteria: 1. Orthodontic banding or wires or partial dentures 2. Severe periodontal disease (no sites with PPD > 5mm), including but not limited to purulent exudate, generalized mobility, and or severe recession 3. Any disease or conditions that could be expected to interfere with examination procedures or the subject safely completing the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bleeding on Marginal Probing (BOMP) – Angular Bleeding Index (Van der Weijden 1994). This score will be done at session 1, 2 and 3. The gingiva is lightly dried with compressed air and lightly probed with a probe. The probe is inserted into the gingival crevice to a depth of approximately 2mm or until slight resistance is felt. The probe is run gently along the marginal gingival holding the probe at a an angle of approximately 60 degrees to the longitudinal axis of the tooth and in contact with the sulcular epithelium. Minimum axial force is used to avoid undue penetration in the tissue. The probe is moved around the crevice gently stretching the epithelium. A bleeding score is given to six gingival areas of the tooth. These are the disto-vestibular, vestibular, mesio-vestibular, disto-lingual, lingual and the mesio-lingual regions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Turesky Modification of the Quigley Hein Plaque Index (TQPHI) This score will be done at session 1, 2 and 3. Dental Plaque and debris will be graded using the same scale as the Turesky Index, but at the following six (6) sites: Mesial, distal and mid surfaces on the facial aspect; Mesial, distal and mid surfaces on the lingual aspect. The area to be graded on the mesial and distal will be determined by three reference points. These points are the line angle of the tooth to the contact point both bordered by the gingival margin. This allows a small triangular area to be graded. In the event that there is no contact between teeth, the height of contour of the tooth should be used as the reference point. SCORE CRITERIA: 0. No plaque / debris. 1. Separate flecks of plaque at the cervical margin of the tooth 2. A thin continuous band of plaque (up to 1mm) at the cervical margin of the tooth 3. A band of plaque wider than 1mm but covering less than 1/3 of the crown of the tooth. 4. Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth 5. Plaque covering 2/3 or more of the crown of the tooth | — |
Contacts
Public ContactP.A. Versteeg
Academic Center Dentistry Amsterdam (ACTA) Department of Parodentology
Outcome results
None listed