K06.0 K05.3
Conditions
Interventions
Group 1: The test group will be instructed to brush at home 2 times a day for 3 years exclusively with a new power toothbrush from the Procter & Gamble Company.
Both groups receive the same written cl
Sponsors
The Procter & Gamble CompanyWorldwide Clinical Investigations—Oral
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: • give written informed consent; • regularly use a manual toothbrush; • agree to be contacted for appointment reminders; • be between the ages of 18 and 65; • be in good general health; • minimum of 16 scorable teeth (not including third molars, teeth with orthodontic appliances, bridges, crowns or implants); • having at least 2 teeth with buccal recession of =2mm, which were not associated with restorations or root caries at the gingival margin (reference teeth); • agree not to participate in any other oral care clinical study for the duration of this study; • agree to refrain from using any non-study toothbrushes and dentifrices for the study duration (subject will be allowed to continue using rinse and use interdental hygiene devices but they will be instructed not to add/change any other oral hygiene products, including whitening products etc.); • agree to follow study procedures and to return for the scheduled clinical visits; • agree to refrain from elective dentistry, including dental prophylaxis, within 4 weeks prior to month 12, 24 or month 36 visits
Exclusion criteria
Exclusion criteria: Subjects will be excluded from study participation where there is evidence of: • current or have recently (within the last 30 days) participated in any other oral hygiene clinical study; • dental professionals or dental students; • current severe chronic illness or infectious disease that might influence or preclude subject’s participation in the study (e.g. AIDS, diabetes); • any disease or conditions that could be expected to interfere with examination procedures or the subject safely completing the study; • bad oral cleanliness, no agreement to comply with study design; • any physical limitations that might preclude normal oral hygiene procedures; • self-reported pregnancy or breast feeding as determined by medical history; • received therapy with any drugs for at least three consecutive days within the last 28 days that might affect the outcome of the study (i.e. anti-inflammatory medications, Dilantin, NSAIDs); • use drugs that can cause gum overgrowth (i.e. Calcium-Antagonist like Nifidepin; Hydantoin; Ciclosporin); • known allergic reactions to any of the test substances or other allergic reactions to dental materials or oral hygiene products; • medical condition or history requiring prophylactic antibiotic coverage prior to dental treatment; • evidence of major hard or soft tissue lesions or trauma at Baseline visit; • carious lesions requiring restorative treatment or active treatment for periodontitis; • gingival recession that was a consequence of periodontal treatment or chronic periodontitis; • elective dentistry, including dental prophylaxis, within 4 weeks prior to Baseline; • current orthodontic treatment; • pacemakers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| gingival recession are measured on all teeth at 6 sites per tooth at baseline, after one year, and after 2 and 3 years with a periodontal probe (PCP15) | — |
Secondary
| Measure | Time frame |
|---|---|
| probing pocket depth clinical attachment level bleeding on probing are measured on all teeth at 6 sites per tooth at baseline, after one year, and after 2 and 3 years with a periodontal probe (PCP15) | — |
Countries
Germany
Contacts
Public ContactChristian Graetz
Christian-Albrechts-Universität zu KielKlinik für Zahnerhaltungskunde und Parodontologie
Outcome results
None listed