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A 6-month placebo-controlled CPC-mouthrinse study.

A 6-month placebo-controlled CPC-mouthrinse study.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25365
Enrollment
60
Registered
2009-06-11
Start date
2009-06-23
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingivitis

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.

Sponsors

Dentaid International, Ronda Can Fatjo 10, 08290 CERDANYOLA - BACELONA, SPAIN, masdevall@dentaid.es
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Oral lesions and/or periodontal pockets >5 mm; 2. Pregnancy or systemic diseases such as diabetes.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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); 3. VAS-QUESTIONAIRE. Results from the VAS questionnaire to evaluate the subject¡¯s attitude towards to the used products.

Contacts

Public ContactG.A. Weijden, van der

Acedemisch Centrum Tandheelkunde Amsterdam (ACTA) Afdeling CPT- Parodontologie Gustav Mahlerlaan 3004

ga.vd.weijden@acta.nl+31 (0)20 5188307

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)