Gingivitis
Conditions
Keywords
Dental Plaque; Gum health
Brief summary
The goal of this clinical trial is to learn if powered toothbrushing is more effective than manual toothbrushing in removing dental plaque. It will also learn about the safety of power toothbrushing. The main questions the study aims to answer are: Does power toothbrushing remove more dental plaque than manual toothbrushing? Does power toothbrushing reduce symptoms of gingivitis better than manual toothbrushing? Participants will: Brush their teeth twice a day with either a manual or power toothbrush Visit the clinic twice during the study, after two and six weeks after the study starts. Keep a diary of when they brushed their teeth
Interventions
DEVICEpower toothbrush
Sonicare Powered Toothbrush and All-in-One Brush head
DEVICEmanual toothbrush
Colgate Classic Adult manual toothbrush
Sponsors
Philips Clinical & Medical Affairs Global
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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 * Willing to attend all study visits * Agree to return study materials at the required visit(s) * Between the ages of 18-65 years * A non-smoker * Minimum of 20 'scorable' teeth (excluding 3rd molars) * Average plaque score of \>1.8 per Modified Plaque Index scoring with 3-6 hours of plaque accumulation * Gingival bleeding score of \>1 on a minimum of 50 gingival sites per Gingival Bleeding Index * Regular manual toothbrush user
Exclusion criteria
* Pregnant or nursing per subject report * A medical or dental condition that would be unduly affected by participation in this study, per Investigator discretion * A medical condition requiring antibiotic pre-medication prior to dental appointments * Diagnosis of xerostomia * 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 Currently using professionally dispensed bleaching products * A known allergy or sensitivity to products planned for use in this study * Unwilling to abstain from all other oral hygiene products other than those prescribed for the duration of the study * Participated in an oral care study within the previous 60 days * Employee or a relative of an employee of the Site clinical research department, dental school, or a dental products manufacturing, research or marketing firm * 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, wires or brackets * A professional prophylaxis within 4 weeks of the study * Regular power toothbrush user
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare the reduction in surface plaque for power toothbrush to manual toothbrush after 6 weeks | 6 weeks | Surface plaque measured by Lobene and Soparkar Modified Quigley-Hein Plaque Index (MPI) using six sites per tooth (distobuccal, buccal, mesiobuccal and distolingual, lingual, mesiolingual) where 0=no plaque, 1. separate flecks of plaque at the cervical margin of the tooth, 2. a thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth, 3. a band of plaque wider than 1 mm covering less than one third of the crown of the tooth, 4. plaque covering at least one-third but less than two-thirds of the crown of the tooth, 5. plaque covering two-thirds or more of the crown of the tooth. Change in MPI will be calculated by subtracting follow-up MPI score from baseline MPI score. Differences in MPI will be compared between the manual and power toothbrush groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare the reduction in surface plaque for power toothbrush to manual toothbrush after 2 weeks | 2 weeks | Surface plaque measured by Lobene and Soparkar Modified Quigley-Hein Plaque Index (MPI) using six sites per tooth (distobuccal, buccal, mesiobuccal and distolingual, lingual, mesiolingual) where 0=no plaque, 1. separate flecks of plaque at the cervical margin of the tooth, 2. a thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth, 3. a band of plaque wider than 1 mm covering less than one third of the crown of the tooth, 4. plaque covering at least one-third but less than two-thirds of the crown of the tooth, 5. plaque covering two-thirds or more of the crown of the tooth. Change in MPI will be calculated by subtracting follow-up MPI score from baseline MPI score. Differences in MPI will be compared between the manual and power toothbrush groups. |
| Compare the reduction in gingivitis for power toothbrush to manual toothbrush after 2 weeks | 2 weeks | Gingivitis is measured by Modified Gingival Index (MGI) (Lobene et al 1986) using six sites per tooth (distobuccal, buccal, mesiobuccal and distolingual, lingual, mesiolingual) where 0=absence of inflammation, 1. mild inflammation; slight change in color, little change in texture of the marginal or papillary gingival unit, 2. mild inflammation; criteria as shown above but involving the entire marginal or papillary gingiva, 3. moderate inflammation glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingiva, 4. severe inflammation, marked redness, edema, and/or hypertrophy of the marginal or papillary gingiva, spontaneous bleeding, congestion or ulceration. Change in MGI will be calculated by subtracting follow-up MPI score from baseline MGI score. Differences in MGI will be compared between the manual and power toothbrush groups. |
| Compare the reduction in gingivitis for power toothbrush to manual toothbrush after 6 weeks | 6 weeks | Gingivitis is measured by Modified Gingival Index (MGI) (Lobene et al 1986) using six sites per tooth (distobuccal, buccal, mesiobuccal and distolingual, lingual, mesiolingual) where 0=absence of inflammation, 1. mild inflammation; slight change in color, little change in texture of the marginal or papillary gingival unit, 2. mild inflammation; criteria as shown above but involving the entire marginal or papillary gingiva, 3. moderate inflammation glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingiva, 4. severe inflammation, marked redness, edema, and/or hypertrophy of the marginal or papillary gingiva, spontaneous bleeding, congestion or ulceration. Change in MGI will be calculated by subtracting follow-up MPI score from baseline MGI score. Differences in MGI will be compared between the manual and power toothbrush groups. |
| Compare the reduction in gingival bleeding for power toothbrush to manual toothbrush after 2 weeks | 2 weeks | Gingival bleeding is measured by Gingival Bleeding Index (GBI), (Van der Weijden et al 1994) using six sites per tooth (distobuccal, buccal, mesiobuccal and distolingual, lingual, mesiolingual) where 0 = no bleeding, 1. = bleeding on gently probing, 2. = bleeding appears immediately upon gently probing, 3. = spontaneous bleeding which is present prior to probing. Change in GBI will be calculated by subtracting follow-up GBI score from baseline GBI score. Differences in GBI will be compared between the manual and power toothbrush groups. |
| Compare the reduction in gingival bleeding for power toothbrush to manual toothbrush after 6 weeks | 6 weeks | Gingival bleeding is measured by Gingival Bleeding Index (GBI), (Van der Weijden et al 1994) using six sites per tooth (distobuccal, buccal, mesiobuccal and distolingual, lingual, mesiolingual) where 0 = no bleeding, 1. = bleeding on gently probing, 2. = bleeding appears immediately upon gently probing, 3. = spontaneous bleeding which is present prior to probing. Change in GBI will be calculated by subtracting follow-up GBI score from baseline GBI score. Differences in GBI will be compared between the manual and power toothbrush groups. |
Countries
United States
Outcome results
None listed