Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Pulp molecular and gingival crevicular fluid (GCF) enzymological profiles during orthodontic treatment
Acronym
Study hypothesis
Enzyme activity will be increased and specific genes will be activated during orthodontic tooth movement.
Ethics approval
Research Ethics Committee, Faculty of Dentistry, National University of Malaysia (Universiti Kebangsaan Malaysia). Date of approval: 15/06/2007
Study design
Observational longitudinal study
Primary study design
Observational
Secondary study design
Other
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
Activity of the enzymes and genes involved during orthodontic treatment will be identified.
Secondary outcome measures
Potential enzymes and genes for biomarkers will be determined (biomarkers that are involved in tooth movement i.e inflammation, bone formation, bone resorption).
Overall trial start date
01/07/2007
Overall trial end date
01/06/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
1. Patient had periodontal disease
2. Poor oral hygiene
3. Have many missing teeth prior to study
Recruitment start date
01/07/2007
Recruitment end date
01/06/2009
Locations
Countries of recruitment
Malaysia
Trial participating centre
Orthodontic Department
Kuala Lumpur
50300
Malaysia
Sponsor information
Organisation
Ministry of Science, Technology and Innovation (Malaysia)
Sponsor details
Level 1-7
Block C4 & C5
Complex C
Pusat Pentadbiran Kerajaan Persekutuan
Putrajaya
Wilayah Persekutuan
62662
Malaysia
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Ministry of Science, Technology and Innovation (Malaysia)
Alternative name(s)
Ministry of Science, Technology and Innovation, MCTI
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Brazil
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
Basic results (scientific)
Publication list