Evaluating the Effect of Tooth Cleaning Devices on Oral Health

Not Applicable

Completed

• Conditions: Dental Plaque
• Interventions: Device: Manual Toothbrush; Device: Interproximal Cleaning Device

• Registration Number: NCT01250769
• Lead Sponsor: Philips Oral Healthcare

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-05-05
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Study First Submitted QC: 2010-11-29
• Study First Posted: 2010-12-01
• Results First Submitted: 2012-05-31
• Status Verified: 2012-08
• Results First Submitted QC: 2012-08-21
• Last Update Submitted: 2012-08-21
• Results First Posted: 2012-09-19
• Last Update Posted: 2012-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual Toothbrush 1	Manual Toothbrush	Manual Toothbrush used for 1 minute twice a day
Manual Toothbrush 2	Manual Toothbrush	Manual Toothbrush used for 2 minutes twice a day
Manual Toothbrush + Interproximal Cleaning 1	Manual Toothbrush	Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day
Manual Toothbrush + Interproximal Cleaning 1	Interproximal Cleaning Device	Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day
Manual Toothbrush + Interproximal Cleaning 2	Manual Toothbrush	Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day
Manual Toothbrush + Interproximal Cleaning 2	Interproximal Cleaning Device	Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day

Primary Outcome Measures

Name	Time	Method
Residual Protein Concentration	14 days	Residual protein concentration of interproximal plaque samples

Secondary Outcome Measures

Name	Time	Method
Residual Protein Concentration	28 days	Residual protein concentration of interproximal plaque samples
Modified Gingival Index	28 days	Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst)
Gingival Bleeding Index	28 days	Gingival bleeding evaluation using a ordinal scale of 0 to 3; (0 is best; 3 is worst)

Trial Locations

Locations (1)

University Park Research Center; 🇺🇸 Fort Wayne, Indiana, United States