The effect of application of 0.12% chlorhexidine gel-toothpaste compared to 0.12% chlorhexidine mouthwash and regular toothpaste in a 3 day non-brushing model on plaque accumulation

ISRCTN ISRCTN57974544
DOI https://doi.org/10.1186/ISRCTN57974544
Secondary identifying numbers NTR274
Submission date
01/12/2005
Registration date
01/12/2005
Last edited
10/09/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Dagmar Slot
Scientific

Hogeschool INHOLLAND
School of Health
Postvak 32
Louwesweg 1
Amsterdam
1066 EA
Netherlands

Phone +31 (0)20 5188643
Email Dagmar.Slot@inholland.acta.nl

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study acronymDAGMAR - Daily Application of a Gingival Maintenance Antimicrobial Regimen
Study objectivesTray 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedDental plaque
InterventionTray 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 typeOther
Primary outcome measureQuigley & Hein plaque-index after 3 days (72 hours) of 'de novo' plaque accumulation.
Secondary outcome measuresResults from the visual analogue scale (VAS) questionnaire to evaluate the subject's attitude towards to the used products.
Overall study start date19/09/2005
Completion date03/10/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants90
Key inclusion criteria1. >=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
Key exclusion criteria1. Use of medication possibly influencing normal gingival health
2. Pregnancy
Date of first enrolment19/09/2005
Date of final enrolment03/10/2005

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Hogeschool INHOLLAND
Amsterdam
1066 EA
Netherlands

Sponsor information

Academic Centre for Dentistry in Amsterdam (ACTA) (Netherlands)
University/education

Louwesweg 1
Amsterdam
1066 EA
Netherlands

Website http://www.acta.nl/
ROR logo "ROR" https://ror.org/04x5wnb75

Funders

Funder type

University/education

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2007 Yes No