A Study Comparing the Interproximal Plaque and Gingivitis Effects of Three Interdental Cleaning Modalities (PAU)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this research study is to compare the interproximal plaque removal ability of Philips Sonicare Interproximal Cleaning Device to floss (Crest Glide) and Waterpik Waterflosser. In addition, we seek to learn more about the results of using this device on plaque accumulation and what biological processes influence the makeup of plaque and reduction of gingivitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Mild Gingivitis |
Device: Sonicare Interproximal (IP) Cleaning Prototype |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Caregiver) Primary Purpose: Treatment |
| Official Title: | A Randomized Parallel Study Comparing the Interproximal Plaque and Gingivitis Effects of Three Interdental Cleaning Modalities |
- residual protein concentration in posterior sites [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
- GBI and MGI [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
GBI and MGI following single use treatment with either MTB, MTB + IP cleaning prototype, MTB + Waterpik Waterflosser or MTB + floss.
Comparisons of the concentration levels of 272 different pathogens between treatment groups Biomarker profiles following the different treatment modalities Safety endpoints based on adverse events and intraoral exam (soft tissue evaluation).
IP cleaning satisfaction questionnaire following treatment with either MTB, MTB + IP cleaning prototype, MTB + Waterpik Waterflosser or MTB + floss.
| Enrollment: | 80 |
| Study Start Date: | February 2011 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Manual Toothbrush + Sonicare Interproximal Cleaning Prototype
Manual Toothbrush + Sonicare Interproximal (IP) Cleaning Prototype
|
Device: Sonicare Interproximal (IP) Cleaning Prototype
Sonicare Interproximal (IP) Cleaning Prototype used to clean between the teeth 1 time a day in combination with brushing.
|
|
Active Comparator: Manual Toothbrush
Manual Toothbrush
|
Device: Sonicare Interproximal (IP) Cleaning Prototype
Sonicare Interproximal (IP) Cleaning Prototype used to clean between the teeth 1 time a day in combination with brushing.
|
|
Active Comparator: Manual Toothbrush + Floss
Manual Toothbrush + Floss
|
Device: Sonicare Interproximal (IP) Cleaning Prototype
Sonicare Interproximal (IP) Cleaning Prototype used to clean between the teeth 1 time a day in combination with brushing.
|
|
Active Comparator: Manual Toothbrush + Waterpik Ultra Water Flosser
Manual Toothbrush + Waterpik Ultra Water Flosser
|
Device: Sonicare Interproximal (IP) Cleaning Prototype
Sonicare Interproximal (IP) Cleaning Prototype used to clean between the teeth 1 time a day in combination with brushing.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- are in good/excellent health
- are 18 - 70 years old
- have abstained from all oral care in the 12 hours prior to their scheduled appointment, but no more than 18 hours prior
- have abstained from consumption of apples and other sticky fruits in the 12 hours prior to their appointment
- have a minimum of 20 natural teeth (excluding 3rd molars)
- have 2 qualifying Interproximal Unit test sites in each posterior quadrant from 3 approximating teeth : The following are the IU test site qualifiers:
- Each IU test site shall consist of two adjacent teeth with un-restored interproximal surfaces with a closed contact. (Note: restorations are permissible if they do not interfere with plaque and GCF sampling as determined by examiner discretion)
- IU test sites of choice are as follows in the order of preference:
- Molar/premolar
- Premolar/premolar
- Molar/molar
- molar/canine
- have PPD ≤ 4mm at all four sites within each interproximal unit test site
- have ≥ 20 bleeding sites (whole mouth) as determined by the Gingival Bleeding Index
- have provided written informed consent and are willing to participate and be available at all times required for participation
- are willing and able to fully understand and comply with the written and verbal study instructions provided in English
- agree to return all study materials at the final visit
Exclusion Criteria:
- have systemic diseases, Down's syndrome, or known AIDS/HIV;
- Have Diabetes
- are a smoker
- are pregnant or nursing by subject report;
- have a cardiac pacemaker or AICD
- are undergoing or require extensive dental or orthodontic treatment;
- have had oral or gum surgery in the previous 2 months;
- require antibiotic treatment for dental appointments;
- have used antibiotics within 4 weeks of enrollment
- are currently using prescription-dose anti-inflammatory medications or anticoagulants (including aspirin)
Contacts and Locations| United States, North Carolina | |
| GO Health Center, University of North Carolina | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Principal Investigator: | Steven Offenbacher, DDS,PhD,MMS | University of North Carolina, Chapel Hill |
More Information
No publications provided
| Responsible Party: | Steven Offenbacher, DDS PhD MMS, University of North Carolina |
| ClinicalTrials.gov Identifier: | NCT01307358 History of Changes |
| Other Study ID Numbers: | DRC-0742 |
| Study First Received: | February 28, 2011 |
| Last Updated: | June 20, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Gingivitis Gingival Diseases Periodontal Diseases Mouth Diseases Stomatognathic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013