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 |
| Protocol serial number | NTR274 |
| Sponsor | Academic Centre for Dentistry in Amsterdam (ACTA) (Netherlands) |
| Funder | Hogeschool INHOLLAND, School of Health in Diemen, Dentaid Benelux (Netherlands) |
- 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
Scientific
Hogeschool INHOLLAND
School of Health
Postvak 32
Louwesweg 1
Amsterdam
1066 EA
Netherlands
| Phone | +31 (0)20 5188643 |
|---|---|
| Dagmar.Slot@inholland.acta.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | DAGMAR - Daily Application of a Gingival Maintenance Antimicrobial Regimen |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Quigley & Hein plaque-index after 3 days (72 hours) of 'de novo' plaque accumulation. |
| Key secondary outcome measure(s) |
Results from the visual analogue scale (VAS) questionnaire to evaluate the subject's attitude towards to the used products. |
| Completion date | 03/10/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 90 |
| Key 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 |
| Key exclusion criteria | 1. Use of medication possibly influencing normal gingival health 2. Pregnancy |
| Date of first enrolment | 19/09/2005 |
| Date of final enrolment | 03/10/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Hogeschool INHOLLAND
Amsterdam
1066 EA
Netherlands
1066 EA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
