Efficacy and Safety Study of Interproximal Cleaning Modalities on Oral Health

Gingivitis Clinical Trial

Official title:

A Randomized, Parallel Design Study to Assess the Effects of Three Interproximal Cleaning Modalities Versus a Manual Toothbrush Control on Gingivitis and Plaque Following a Period of Home Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02187016
• Other study ID #: MAH-13-0151
• Status: Completed
• Phase: N/A
• First received: July 1, 2014
• Last updated: February 5, 2016
• Start date: June 2014
• Est. completion date: July 2014

Study information

• Verified date: February 2016
• Source: Philips Oral Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of tooth and interproximal cleaning modalities with and without chemistry on oral health over 28 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Be willing and physically able to carry out all study procedures and be available at all times required for participation

• Be able to fully understand and comply with the written and verbal instructions provided

• Provide written Informed Consent

• Be age 18 - 65 years

• Agree to return study materials at the required visits

• Be a non-smoker

• Have a minimum of 20 'scorable' teeth (excluding 3rd molars)

• Have a minimum average plaque score of > 0.5 per RMNPI scoring with 2-6 hours of plaque accumulation

• Have a Gingival Bleeding Index of ->1 on at least 10 sites

• Be a regular manual toothbrush user

• Be a non or irregular flosser defined as using dental floss or any other interproximal cleaning technique once per week or less often

Exclusion Criteria:

• A medical or dental condition that would be unduly affected by participation in this study, per Investigator discretion

• Pregnant or nursing per subject report

• A medical condition requiring antibiotic pre-medication prior to dental appointments

• Diagnosis of xerostomia

• Any oral or extra oral piercing that interferes with the ability to perform study procedures and/or clinical assessments in the mouth

• Currently undergoing or requiring dental/periodontal treatment, or having had periodontal treatment in the six months preceding the study, where the subject's study participation could present an undue safety risk or obscure the evaluation of study endpoints, per Investigator /Examiner discretion

• Oral surgery within the last 2 months

• Current use of professionally dispensed bleaching products

• A known allergy or sensitivity to products planned for use in this study

• Unwillingness to abstain from all other oral hygiene products other than those prescribed for the duration of the study

• Unwillingness to abstain from all other oral hygiene products other than those prescribed for the duration of the study

• Participation in an oral care study within the previous 90 days

• Be an employee or a relative of an employee of the Site clinical research department, dental school, or a dental products manufacturing, research or marketing firm

• Are a dental student or dental professional

• A cardiac pacemaker or implanted cardiac defibrillator

• Insulin-Dependent Diabetes

• Current use of antibiotic medications or use within 4 weeks of enrollment

• Current use of prescription-dose anti-inflammatory medications or anticoagulants; (including aspirin > 81 mg daily)

• Presence of advanced periodontal disease or excessive gingival recession, per Investigator/Examiner discretion

• Heavy deposits of calculus, either supragingival and/or subgingival, per Investigator/Examiner discretion

• Extensive crown or bridge work and/or rampant decay, per Investigator/Examiner discretion

• Presence of orthodontic bands interfering with efficacy outcome(s) per Investigator/Examiner discretion

• Have a professional prophylaxis within 4 weeks of the study

• Be a regular power toothbrush user

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

• Gingivitis

Intervention

Device:
• AirFloss + BreathRx
Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning plus Rinse used once daily.
• AirFloss + Listerine
Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning plus Rinse used once daily.
• Dental Floss
Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning used once daily.
• Manual Toothbrush
Manual Toothbrush used twice daily, 1 minute.

Locations

Country	Name	City	State
United States	Silverstone Research Group	Las Vegas	Nevada

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	Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 14	MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation).	14 days	No
Secondary	Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 28	MGI is a validated assessment of Gingival inflammation using a 4 point scale from 0 (absence of inflammation) to 4 (severe inflammation).	28 days	No
Secondary	Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 14	GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).	14 days	No
Secondary	Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 28	GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).	28 days	No
Secondary	Change From Baseline Using Rustogi Modification of the Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 14	RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).	14 days	No
Secondary	Change From Baseline in Rustogi Modification of Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 28	RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).	28 days	No