search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


The plaque inhibitory effect of a CPC mouthrinse in a 3-day plaque accumulation model-A cross-over study


- candidate number3331
- NTR NumberNTR1329
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-jun-2008
- Secondary IDsMEC 08/112 
- Public TitleThe plaque inhibitory effect of a CPC mouthrinse in a 3-day plaque accumulation model-A cross-over study
- Scientific TitleThe plaque inhibitory effect of a CPC mouthrinse in a 3-day plaque accumulation model-A cross-over study
- ACRONYMN/A
- hypothesisThe CPC-mouthrinse inhibit 15% less of 'de novo' plaqueformation compared to a placebo and hexitine over a period of 3 days in a non-brushing model.
- Healt Condition(s) or Problem(s) studiedDental plaque, Gingivitis, Mouthrinse
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 27-mei-2008
- planned closingdate27-jun-2008
- Target number of participants50
- InterventionsAt 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 and 3 in order to have all subjects run the protocol with all three products.
- Primary outcomeBleeding 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 outcomeTuresky 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
- TimepointsSession 1:
-Professional oral profylaxis
-Measurements (after 3 days of profylaxis)
Session 2:
-Professional oral profylaxis
-Measurements (after 3 days of profylaxis)
Session 3:
-Professional oral profylaxis
-Measurements (after 3 days of profylaxis)
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES P.A. Versteeg
- CONTACT for SCIENTIFIC QUERIESDr. G.A. Weijden, van der
- Sponsor/Initiator Dentaid International
- Funding
(Source(s) of Monetary or Material Support)
Dentaid International
- PublicationsN/A
- Brief summary The present study aims at testing whether a CPC-mouthrinse has a potential to inhibit ‘de novo’ plaque formation as compared to a placebo and hexetidine.
- Main changes (audit trail)
- RECORD27-mei-2008 - 11-jun-2008


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl