The study will determine the effects of adding mechanical plaque control to a person's oral care regimen. Participants who qualify to participate in the study will will have an equal chance of being assigned to one of three groups. They will be asked to follow their assigned oral care regimen, fill out subject diaries as instructed, and return to the clinic two weeks and four weeks afterward to have their mouths examined.
At baseline, the prescreened subjects will present to the clinical site for baseline examinations (oral exam, plaque, gingivitis and gingival bleeding assessments) having refrained from oral hygiene for at least 12 hours, but no more than 18 hours and from eating for at least 2 hours prior to that examination. After the baseline oral examinations, and assessment of other inclusion/exclusion criteria, qualifying subjects will be randomly assigned to one of the three treatment groups. Immediately following this randomization, all subjects will begin their regimen of brushing with a manual toothbrush while two of the groups will also receive an experimental interdental cleaning device to use either with water or with an assigned mouthrinse following the label instructions described on the experimental device label. Subjects who are assigned to the negative control group will use the manual toothbrush and provided toothpaste as their sole mean of oral hygiene. Subjects assigned to the Device-only control group will brush with a manual toothbrush and use the Experimental Interdental Cleaning Device with water. Finally, those subjects randomized to the test group will brush with a manual toothbrush and use the experimental interdental cleaning device in combination with a marketed antiseptic mouthrinse. Subjects will brush twice-a-day and if assigned, will use the experimental interdental cleaning device once-a-day for 4 weeks, post-brushing, according to instructions given by the study personnel. The first oral hygiene procedure will be conducted under supervision of study personnel at the research site. All other study material usage will be unsupervised and the subjects will be required to maintain a Diary Card to document daily oral hygiene routine. Compliance will be evaluated at each visit by reviewing the subject diaries and, when applicable, by weighing residual volumes of returned mouthrinse. Subjects will refrain from the use of any interdental cleaning device, unless assigned by the randomization schedule (i.e., not to use dental floss, toothpick, etc), unless it is used to remove impacted food between the teeth, during the course of the study. No other oral hygiene procedures will be permitted, including teeth cleaning or dental work except for an emergency. At the two and four-week visits, the Modified Gingival Index (MGI), the Bleeding Index (BI) and the Turesky modification of the Quigley-Hein Plaque Index (PI) will be scored and the oral tissue examinations performed. At the two and four-week visits, subjects will not have used their test materials for at least 12 hours, but no more than 18 hours.
Subjects will be instructed to follow their usual oral hygiene habits with the provided toothbrush and toothpaste, and to use their assigned product once a day for a period of 4 weeks.
Subjects will be instructed to follow their usual oral hygiene habits with the provided toothbrush and toothpaste, and to use their assigned product once a day for a period of 4 weeks.
BioSci Research America, Inc
Las Vegas, Nevada, United States
Interproximal Mean Plaque Index at Week 4
Plaque area was scored using the Turesky modification of the Quigley-Hein Plaque Index (PI), on six surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, using following score range; 0: indicates no plaque; 1: separate flecks or discontinuous band of plaque on the gingival (cervical) margin; 2: thin (up to 1 millimeter \[mm\]), continuous band of plaque at the gingival margin; 3: band of plaque wider than 1mm but less than1/3 of the surface; 4: plaque covering 1/3 or more, but less than 2/3 of the surface; 5 plaque covering 2/3 or more of the surface.
Time frame: Week 4
Whole-mouth Mean Plaque Index at Week 4
Plaque area was scored using the Turesky modification of the Quigley-Hein Plaque Index (PI), on six surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, using following score range; 0: indicates no plaque; 1: separate flecks or discontinuous band of plaque on the gingival (cervical) margin; 2: thin (up to 1 mm), continuous band of plaque at the gingival margin; 3: band of plaque wider than 1mm but less than1/3 of the surface; 4: plaque covering 1/3 or more, but less than 2/3 of the surface; 5 plaque covering 2/3 or more of the surface.
Time frame: Week 4
Interproximal Mean Modified Gingival Index (Mean MGI) at Week 2 and 4
Gingivitis was assessed by the MGI on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth as per following score range: 0 indicates normal (absence of inflammation;) 1 indicates mild inflammation (slight change in color, little change in texture) of any portion of the entire gingival unit; 2 indicates mild inflammation of the entire gingival unit; 3 indicates moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit. 4 indicates severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit.
Time frame: Week 2 and 4
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
140
Whole-mouth Modified Gingival Index (Mean MGI) at Week 2 and 4
Gingivitis was assessed by the MGI on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth as per following score range: 0 indicates normal (absence of inflammation;) 1 indicates mild inflammation (slight change in color, little change in texture) of any portion of the entire gingival unit; 2 indicates mild inflammation of the entire gingival unit; 3 indicates moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit. 4 indicates severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit.
Time frame: Week 2 and 4
Interproximal Mean Plaque Index (Mean PI) at Week 2
Plaque area was scored using the Turesky modification of the Quigley-Hein Plaque Index (PI), on six surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, using following score range; 0: indicates no plaque; 1: separate flecks or discontinuous band of plaque on the gingival (cervical) margin; 2: thin (up to 1 mm), continuous band of plaque at the gingival margin; 3: band of plaque wider than 1mm but less than1/3 of the surface; 4: plaque covering 1/3 or more, but less than 2/3 of the surface; 5 plaque covering 2/3 or more of the surface.
Time frame: Week 2
Whole-mouth Mean Plaque Index (Mean PI) at Week 2
Plaque area was scored using the Turesky modification of the Quigley-Hein Plaque Index (PI), on six surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, using following score range; 0: indicates no plaque; 1: separate flecks or discontinuous band of plaque on the gingival (cervical) margin; 2: thin (up to 1 mm), continuous band of plaque at the gingival margin; 3: band of plaque wider than 1mm but less than1/3 of the surface; 4: plaque covering 1/3 or more, but less than 2/3 of the surface; 5 plaque covering 2/3 or more of the surface.
Time frame: Week 2
Interproximal Mean Bleeding Index (Mean BI) at Week 2 and 4
Bleeding was assessed using the Gingival BI. A periodontal probe with a 0.5 millimeter (mm) diameter tip was inserted into the gingival crevice, and swept from distal to mesial around the tooth at an angle of approximately 60 degree, while in contact with the sulcular epithelium. Each of four gingival areas (distobuccal, midbuccal, mid-lingual, and mesiolingual) around each tooth was assessed. After approximately 30 seconds, bleeding at each gingival unit was recorded according to the following scale: 0 indicates absence of bleeding after 30 seconds; 1 indicates bleeding after 30 seconds; 2 indicates immediate bleeding.
Time frame: Week 2 and 4
Whole-mouth Mean Bleeding Index (Mean BI) at Week 2 and 4
Bleeding was assessed using the Gingival BI. A periodontal probe with a 0.5 millimeter (mm) diameter tip was inserted into the gingival crevice, and swept from distal to mesial around the tooth at an angle of approximately 60 degree, while in contact with the sulcular epithelium. Each of four gingival areas (distobuccal, midbuccal, mid-lingual, and mesiolingual) around each tooth was assessed. After approximately 30 seconds, bleeding at each gingival unit was recorded according to the following scale: 0 indicates absence of bleeding after 30 seconds; 1 indicates bleeding after 30 seconds; 2 indicates immediate bleeding.
Time frame: Week 2 and 4