|- candidate number||5923|
|- NTR Number||NTR1855|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-jun-2009|
|- Secondary IDs||09/098 Academisch medisch centrum|
|- Public Title||A 6-month placebo-controlled CPC-mouthrinse study.|
|- Scientific Title||A 6-month placebo-controlled CPC-mouthrinse study.|
|- hypothesis||The present study aims at testing whether the 0.07% CPC-mouthrinse has a potential to inhibit gingival inflammation as compared to a placebo over a 6 month period.|
|- Healt Condition(s) or Problem(s) studied||Gingivitis|
|- Inclusion criteria||1. >18 years of age;|
2. A minimum of 5 evaluable teeth in each quadrant (with no partial dentures, orthodontic banding or wires).
|- Exclusion criteria||1. Oral lesions and/or periodontal pockets >5 mm;|
2. Pregnancy or systemic diseases such as diabetes.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||23-jun-2009|
|- planned closingdate||8-dec-2009|
|- Target number of participants||60|
|- Interventions||At baseline, 3 months and 6 months:|
1. Brushing 2x a day: Everclean toothpaste (a standard toothpaste) and VITIS Encias toothbrush;
2. Rinsing 3x a day for 30 seconds with 15 ml with 0.07% CPC-mouthrinse OR a placebo mouthrinse.
|- Primary outcome||PLAQUE (Quigley & Hein, 1962). This score will be scored on the pre-experimental phase, baseline and at the final examination (after 4 months). Plaque is assessed after disclosing with Mira-2-Ton® (Hager & Werken GmbH & Co. KG. Duisburg, Germany), using the Turesky (Turesky et al.1970) modification of the index (Quigley & Hein 1962) scored at six sites per tooth as suggested by Lobene et al. (1982) where the absence or presence of plaque is recorded on a scale 0-5 (0=no plaque, 5=plaque covered more than two-thirds of the tooth surface).|
|- Secondary outcome||1. BLEEDING ON MARGINAL PROBING (BOMP, Van der Weijden 1994).|
This score will be scored on the pre-experimental phase, baseline and at the final examination (after 4 months). 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;
2. GRÜNDEMANN MODIFIED STAIN INDEX (GMSI, Grundemann 2000).
The buccal surface is divided into four zones, by straightening the angle of the mesial and distal surfaces to allow for a wider gingival/marginal area. In this study, the buccal surfaces of all scorable teeth will be scored on a scale 0-3. (0= no stain, 3= heavy stain);
Results from the VAS questionnaire to evaluate the subject¡¯s attitude towards to the used products.
|- Timepoints||Baseline, 3 months and 6 months.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. G.A. Weijden, van der|
|- CONTACT for SCIENTIFIC QUERIES||Dr. G.A. Weijden, van der|
|- Sponsor/Initiator ||Dentaid International|
(Source(s) of Monetary or Material Support)
|- Brief summary||Background of the study: |
Maintaining an adequate low level of plaque through daily tooth brushing is often not feasible. Chemotherapeutic agents as an adjunct to mechanical plaque control would be valuable. Cetylpyridinium chloride (CPC) has proven to be an effective inhibitor of plaque accumulation.
Objective of the study:
The present study aims at testing whether the 0.07% CPC-mouthrinse has a potential to inhibit gingival inflammation as compared to a placebo over a 6 month period.
This study is designed as a double examiner-blind, 2-group cross-over. Subjects will recruited in The Netherlands and receive a unique trial number and will be randomly assigned to one of the 2 groups according to a Latin square design. On the 1st appointment microbiologic measurements (plaque- and saliva samples) and clinical parameters (plaque, bleeding on marginal probing, and stain) will be scored. After completion of the clinical assessments a dental hygienist will provide a professional dental scale and polish. Each subject will receive a written and verbal instruction about how to use the mouthrinse. The subjects will also receive a standard toothbrush and toothpaste to brush 3 times a day. All subjects are instructed to use their allocated products 3 times a day. At this moment subjects will rinse for the first time with their allocated mouthrinse. After 3 and 6 months, subjects return to the clinic for the microbiological and clinical assessments. Subsequently all subjects receive a questionnaire to evaluate their attitude towards the used products using Visual Analogue Scales (VAS-scores).
|- Main changes (audit trail)|
|- RECORD||11-jun-2009 - 6-okt-2009|