Condition category
Oral Health
Date applied
01/12/2005
Date assigned
01/12/2005
Last edited
10/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Dagmar Slot

ORCID ID

Contact details

Hogeschool INHOLLAND
School of Health
Postvak 32
Louwesweg 1
Amsterdam
1066 EA
Netherlands
+31 (0)20 5188643
Dagmar.Slot@inholland.acta.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR274

Study information

Scientific title

Acronym

DAGMAR - Daily Application of a Gingival Maintenance Antimicrobial Regimen

Study hypothesis

Tray application of 0.12% chlorhexidine gel-toothpaste has more than 15% better effect
on 'de novo' plaque accumulation compared to tray application of regular toothpaste in a 3 day non-brushing model.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Dental plaque

Intervention

Tray application of 0.12% chlorhexidine gel-toothpaste twice daily for 2 minutes or tray application of regular toothpaste twice daily for 2 minutes or rinsing with 0.12% chlorhexidine mouthwash twice daily for 1 minute, during a 3 day non-brushing period.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Quigley & Hein plaque-index after 3 days (72 hours) of 'de novo' plaque accumulation.

Secondary outcome measures

Results from the visual analogue scale (VAS) questionnaire to evaluate the subject's attitude towards to the used products.

Overall trial start date

19/09/2005

Overall trial end date

03/10/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. >=18 years
2. Systemically healthy
3. >=20 teeth
4. 5 teeth per quadrant
5. No pockets >5 mm
6. No orthodontic appliances
7. No removable (partial) dentures

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

90

Participant exclusion criteria

1. Use of medication possibly influencing normal gingival health
2. Pregnancy

Recruitment start date

19/09/2005

Recruitment end date

03/10/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

Hogeschool INHOLLAND
Amsterdam
1066 EA
Netherlands

Sponsor information

Organisation

Academic Centre for Dentistry in Amsterdam (ACTA) (Netherlands)

Sponsor details

Louwesweg 1
Amsterdam
1066 EA
Netherlands

Sponsor type

University/education

Website

http://www.acta.nl/

Funders

Funder type

University/education

Funder name

Hogeschool INHOLLAND, School of Health in Diemen, Dentaid Benelux (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17250578

Publication citations

  1. Results

    Slot DE, Lindeboom R, Rosema NA, Timmerman MF, van der Weijden GA, The effect of 0.12% chlorhexidine dentifrice gel on plaque accumulation: a 3-day non-brushing model., Int J Dent Hyg, 2007, 5, 1, 45-52, doi: 10.1111/j.1601-5037.2007.00227.x.

Additional files

Editorial Notes