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
Secondary identifying numbers N/A
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

Orthodontic Department
Faculty of Dentistry
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz
Kuala Lumpur
50300
Malaysia

Study information

Study designObservational longitudinal study
Primary study designObservational
Secondary study designOther
Study setting(s)Other
Study typeTreatment
Scientific titlePulp molecular and gingival crevicular fluid (GCF) enzymological profiles during orthodontic treatment
Study objectivesEnzyme 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) studiedEnzyme activity and gene profile during tooth movement
Intervention1. 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 typeOther
Primary outcome measureActivity of the enzymes and genes involved during orthodontic treatment will be identified.
Secondary outcome measuresPotential enzymes and genes for biomarkers will be determined (biomarkers that are involved in tooth movement i.e inflammation, bone formation, bone resorption).
Overall study start date01/07/2007
Completion date01/06/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants40
Key inclusion criteria1. 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 criteria1. Patient had periodontal disease
2. Poor oral hygiene
3. Have many missing teeth prior to study
Date of first enrolment01/07/2007
Date of final enrolment01/06/2009

Locations

Countries of recruitment

  • Malaysia

Study participating centre

Orthodontic Department
Kuala Lumpur
50300
Malaysia

Sponsor information

Ministry of Science, Technology and Innovation (Malaysia)
Government

Level 1-7
Block C4 & C5
Complex C
Pusat Pentadbiran Kerajaan Persekutuan
Putrajaya
Wilayah Persekutuan
62662
Malaysia

Website http://www.mosti.gov.my
ROR logo "ROR" https://ror.org/012s3r374

Funders

Funder type

Government

Ministry of Science, Technology and Innovation (Malaysia)
Government organisation / National government
Alternative name(s)
Ministry of Science, Technology and Innovation, Ministério da Ciência, Tecnologia e Inovações, Governo Federal do Brasil Ministério da Ciência, Tecnologia, Inovações e Comunicações, MCTI
Location
Brazil

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