Evaluating the Effect of Tooth Cleaning Devices on Oral Health

Philips

Status: Completed

Conditions: Dental Plaque

Treatments: Device: Manual Toothbrush; Device: Interproximal Cleaning Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT01250769

DRC-0703

Details and patient eligibility

About

This is a study to evaluate the safety and the efficacy of tooth and interproximal cleaning modalities on oral health.

Enrollment: 170 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• are in good/excellent health;
• are 18 - 70 years old;
• have a minimum of 20 natural teeth (excluding 3rd molars);
• have sufficient test sites;
• have ≥ 20 bleeding sites;
• are willing to participate and available for participation.

Exclusion criteria

• have systemic diseases such as Down's syndrome, or known AIDS/HIV;
• have insulin dependant Diabetes;
• are pregnant or nursing by subject report;
• have a cardiac pacemaker
• are undergoing or require extensive dental or orthodontic treatment;
• require antibiotic treatment for dental appointments;
• have heavy deposits of calculus;
• have severe gingivitis or periodontitis;
• have extensive crown or bridge work and/or rampant decay;
• currently use bleaching trays;
• have any oral or extraoral piercing on lips or in mouth;
• have a professional prophylaxis within 4 weeks of study;
• participation in a prior study ≤ 20 days;
• employed by a oral healthcare products company or research institution.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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170 participants in 4 patient groups

Manual Toothbrush 1

Active Comparator group

Description:

Manual Toothbrush used for 1 minute twice a day

Treatment:

Device: Manual Toothbrush

Manual Toothbrush 2

Active Comparator group

Description:

Manual Toothbrush used for 2 minutes twice a day

Treatment:

Device: Manual Toothbrush

Manual Toothbrush + Interproximal Cleaning 1

Experimental group

Description:

Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day

Treatment:

Device: Interproximal Cleaning Device

Device: Manual Toothbrush

Manual Toothbrush + Interproximal Cleaning 2

Experimental group

Description:

Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day

Treatment:

Device: Interproximal Cleaning Device

Device: Manual Toothbrush