Investigation of enzymes in gingival crevicular fluid (GCF) and their gene activation profiles during orthodontic treatment
| ISRCTN | ISRCTN47483728 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47483728 |
| Protocol serial number | N/A |
| Sponsor | Ministry of Science, Technology and Innovation (Malaysia) |
| Funder | Ministry of Science, Technology and Innovation (Malaysia) |
- Submission date
- 29/07/2008
- Registration date
- 14/08/2008
- Last edited
- 09/09/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Rohaya Megat Abdul Wahab
Scientific
Scientific
Orthodontic Department
Faculty of Dentistry
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz
Kuala Lumpur
50300
Malaysia
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational longitudinal study |
| Secondary study design | Other |
| Scientific title | Pulp molecular and gingival crevicular fluid (GCF) enzymological profiles during orthodontic treatment |
| Study objectives | Enzyme activity will be increased and specific genes will be activated during orthodontic tooth movement. |
| Ethics approval(s) | Research Ethics Committee, Faculty of Dentistry, National University of Malaysia (Universiti Kebangsaan Malaysia). Date of approval: 15/06/2007 |
| Health condition(s) or problem(s) studied | Enzyme activity and gene profile during tooth movement |
| Intervention | 1. Assessment of the orthodontic appliance and evaluation of tooth movement at monthly interval (week 4, 8 and 12). The whole orthodontic treatment will be monitored clinically over 2 years. 2. Characterisation of GCF before and after the placement of orthodontic appliances. GCF samples taken at week 1, 2, 3, 4, 6, 8, 11 and 12 at the mesial and distal aspect of test (distalised canine) and control teeth (canine teeth that have not been affected by the orthodontic treatment) after premolar teeth have been extracted 3. Pulp tissues characterisation of extracted teeth at 6 weeks. The test tooth will be the upper first premolar that will be extracted after orthodontic treatment. The control tooth will be a lower first premolar that has not been affected by the orthodontic treatment. 4. Characterisation of mRNA from pulp tissues (as in method 3 above) and determination of mRNA quality for microarray hybridisation 5. Microarray analysis of pulp tissues (as in method 3 above) 6. Bioinformatic analysis of potential genes involved during tooth movement |
| Intervention type | Other |
| Primary outcome measure(s) |
Activity of the enzymes and genes involved during orthodontic treatment will be identified. |
| Key secondary outcome measure(s) |
Potential enzymes and genes for biomarkers will be determined (biomarkers that are involved in tooth movement i.e inflammation, bone formation, bone resorption). |
| Completion date | 01/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | 1. Both males and females, age range 14-30 years 2. Need for orthodontic treatment 3. Good general and periodontal health 4. Not pregnant 5. No use of antiinflammatory drugs, antibiotics or chlorhexidine mouthwash before and during study |
| Key exclusion criteria | 1. Patient had periodontal disease 2. Poor oral hygiene 3. Have many missing teeth prior to study |
| Date of first enrolment | 01/07/2007 |
| Date of final enrolment | 01/06/2009 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Orthodontic Department
Kuala Lumpur
50300
Malaysia
50300
Malaysia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
