|- candidate number||3918|
|- NTR Number||NTR1431|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-sep-2008|
|- Secondary IDs||MEC 08/173 |
|- Public Title||Brush head configuration - Safety and Efficacy|
|- Scientific Title||Brush head configuration - Safety and Efficacy|
|- ACRONYM||Brush head configuration - Safety and Efficacy|
|- hypothesis||The 3 new developed prototype electric brush heads (A,B,C) remove 15% more plaque compared to a EB17 brush head|
|- Healt Condition(s) or Problem(s) studied||Dental plaque|
|- Inclusion criteria||Inclusion: |
1. Be between the ages of 18 and 70
2. Be in good general health as determined by the investigator/designee based on a review of the medical history/update,
3. Possess at least 5 evaluable teeth in each quadrant in the lower jaw
4. No periodontal pockets of 5mm or more
|- Exclusion criteria||Exclusion:|
1. Orthodontic banding or wires or partial dentures,
2. Severe periodontal disease (no sites with PPD > 5mm), including but not limited to purulent exudate, generalized mobility, and or severe recession,
3. Any disease or conditions that could be expected to interfere with examination procedures or the subject safely completing the trial.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||8-jul-2008|
|- planned closingdate||22-jul-2008|
|- Target number of participants||50|
|- Interventions||- Removing plaque with the 4 different brushheads of an electric toothbrush
- To evaluate the efficacy of new brushheads an investigation will be carried out using a randomized single used cross-over model whereby all brushes will be used by each subject, one brush per quadrant.
- Different brushheads:
1: Prototype EB-A
2: Prototype EB-B
3: Prototype EB-C
|- Primary outcome||- Turesky Modification of the Quigley Hein Plaque Index (TQPHI)|
Dental Plaque and debris will be graded using the same scale as the Turesky Index, but at the following six (6) sites:
Mesial, distal and mid surfaces on the facial aspect; Mesial, distal and mid surfaces on the lingual aspect.
The area to be graded on the mesial and distal will be determined by three reference points. These points are the line angle of the tooth to the contact point both bordered by the gingival margin. This allows a small triangular area to be graded. In the event that there is no contact between teeth, the height of contour of the tooth should be used as the reference point.
0 = No plaque / debris.
1 = Separate flecks of plaque at the cervical margin of the tooth
2 = A thin continuous band of plaque (up to 1mm) at the cervical margin of the tooth
3 = A band of plaque wider than 1mm but covering less than 1/3 of the
crown of the tooth.
4 = Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth
5 = Plaque covering 2/3 or more of the crown of the tooth
|- Secondary outcome||GINGIVAL ABRASION|
A complete oral soft tissue examination will be performed at each visit prior to any test procedures. Gingival abrasions will be assessed. Before each assessment gingival abrasions will be stained by applying a disclosing solution (Mira-2-Ton®, Hager and Werken, GmbH & Co., Duisburg, Germany) using cotton swabs. The number and site location of the gingival abrasions are then recorded on CRF, with the exclusion of the third molar and central incisors regions. The gingival tissues are divided into three areas: cervical (cervical free gingiva), interdental (papillary free gingiva) and mid-gingival (attached gingiva). In the upper jaw the palatal mid-gingival area comprises the whole hard palate. The abrasions will be measured by using a PQ-William’s periodontal probe placed across the long axis of the lesions. The abrasions will be scored as "small" if =2 mm, as medium if ≥ 3 but ≤ 5 mm, and as large if >5 mm. Those lesions measuring between 2 mm and 3 mm will be assigned a score of small or medium according to nearest mm mark on the probe.
|- Timepoints||- Appointment 1: screening for inclusion, give written consent, instruction not to brush teeth for 48 hours.
- Appointment 2: Measurements and brushing with all 4 brush heads will be used by each subject, one brush per quadrant.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| P.A. Versteeg|
|- CONTACT for SCIENTIFIC QUERIES||Dr. G.A. Weijden, van der|
|- Sponsor/Initiator ||The Procter & Gamble Company|
(Source(s) of Monetary or Material Support)
|The Procter & Gamble Company|
|- Brief summary||The aim of the present study was to evaluate the effect of 3 new developed brush heads compared to a EB17 brush head in relation to gingival abrasion and plaque removing efficacy |
|- Main changes (audit trail)|
|- RECORD||4-sep-2008 - 16-sep-2008|