Evaluating the Effect of Tooth Cleaning Devices on Oral Health

Dental Plaque Clinical Trial

Official title:

Evaluating the Effect of a Novel Interproximal Cleaning Device on Oral Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01250769
• Other study ID #: DRC-0703
• Status: Completed
• Phase: N/A
• First received: May 5, 2010
• Last updated: August 21, 2012
• Start date: April 2010
• Est. completion date: June 2010

Study information

• Verified date: August 2012
• Source: Philips Oral Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Plaque

Intervention

Device:
• Manual Toothbrush
A standard size manual toothbrush to clean visible tooth surfaces
• Interproximal Cleaning Device
An electronic device that combines water and air to clean between the teeth

Locations

Country	Name	City	State
United States	University Park Research Center	Fort Wayne	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Philips Oral Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Residual Protein Concentration	Residual protein concentration of interproximal plaque samples	14 days	No
Secondary	Residual Protein Concentration	Residual protein concentration of interproximal plaque samples	28 days	No
Secondary	Modified Gingival Index	Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst)	14 days	No
Secondary	Modified Gingival Index	Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst)	28 days	No
Secondary	Gingival Bleeding Index	Gingival bleeding evaluation using an ordinal scale of 0 to 3; (0 is best; 3 is worst)	14 days	No
Secondary	Gingival Bleeding Index	Gingival bleeding evaluation using a ordinal scale of 0 to 3; (0 is best; 3 is worst)	28 days	No