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MANUAL TOOTHBRUSHES AND REVERSAL OF EXPERIMENTAL GINGIVITIS


- candidate number3051
- NTR NumberNTR1233
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-feb-2008
- Secondary IDs07/313 MEC
- Public TitleMANUAL TOOTHBRUSHES AND REVERSAL OF EXPERIMENTAL GINGIVITIS
- Scientific TitleMANUAL TOOTHBRUSHES AND REVERSAL OF EXPERIMENTAL GINGIVITIS
- ACRONYMN/A
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedGingivitis, Dentifrice
- Inclusion criteria1. 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. Be a non-smoker
5. Have a > 25% level of bleeding
6. Be right handed
- Exclusion criteria1. 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 26-feb-2008
- planned closingdate8-mei-2008
- Target number of participants40
- InterventionsFamiliarization Phase:
-Brushing 2x a day 2 minutes: Crest Cavity Protection toothpaste in combination with on alternate days the Oral-B CrossAction ProHealth manual toothbrush or Oral-B Advantage 123 manual toothbrush.
-Using interdental cleaners 2x a day The familiarization phase will last approximately 20 days.
Experimental Gingivitis Phase Subject are instructed to refrain from brushing the lower jaw for the next 21 days, during which time they brush their upper jaw on alternate days with one of the two brushes to further familiarization.
-Brushing 2x a day 2 minutes in the upper jaw: Crest Cavity Protection toothpaste in combination with on alternate days the Oral-B CrossAction ProHealth manual toothbrush or Oral-B Advantage 123 manual toothbrush.

The experimental phase will last 21 days.

Healing Phase:
Brushing 2x a day:Crest Cavity Protection toothpaste in combination with the Oral-B CrossAction ProHealth manual toothbrush and Oral-B Advantage 123 manual toothbrush.

This is according to a split mouth design, whereby either the right or left side of the mouth being brushed for a period of one (1) minute per side with either the CrossAction ProHealth manual toothbrush or the Advantage 123 manual toothbrush, and the opposing side for 1 extra minute with the alternative brush, as randomly assigned.

The healing phase will last 4 weeks.
- Primary outcomeBleeding on Marginal Probing (BOMP) Angular Bleeding Index (Van der Weijden 1994).
This score will be done on day 0, day 21, week 1, week 2 en week 4.
The gingiva is lightly dried with compressed air and lightly probed with a probe. The probe is inserted into the gingival crevice to a depth of approximately 2mm or until slight resistance is felt. The probe is run gently along the marginal gingival holding the probe at a an angle of approximately 60 degrees to the longitudinal axis of the tooth and in contact with the sulcular epithelium. Minimum axial force is used to avoid undue penetration in the tissue. The probe is moved around the crevice gently stretching the epithelium. A bleeding score is given to six gingival areas of the tooth. These are the disto-vestibular, vestibular, mesio-vestibular, disto-lingual, lingual and the mesio-lingual regions.
- Secondary outcomeTuresky Modification of the Quigley Hein Plaque Index (TQPHI)
This score will be done on day 0, day 21, week 1, week 2 en week 4.
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.

SCORE CRITERIA:
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
8 Unscorable tooth
9 Missing tooth
- Timepoints- Familiarization Phase
The familiarization phase will last approximately 20 days.
- Experimental Gingivitis Phase
The experimental phase will last 21 days.
- Healing Phase
The healing phase will last 4 weeks
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. G.A. Weijden, van der
- CONTACT for SCIENTIFIC QUERIESDr. G.A. Weijden, van der
- Sponsor/Initiator The Procter & Gamble Company
- Funding
(Source(s) of Monetary or Material Support)
The Procter & Gamble Company
- PublicationsN/A
- Brief summaryThe study is designed as a two treatment, examiner-blind, randomized, experimental gingivitis, split-mouth design study. A 3-week non-brushing period (experimental gingivitis) will be introduced to standardize the level of gingivitis inflammation at the start of the actual experiment. This model will assess the reduction of gingivitis after this 3-week experimental gingivitis (EG) period comparing 2 manual brushes in a split-mouth design.
- Main changes (audit trail)
- RECORD5-feb-2008 - 20-mrt-2008


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