Condition category
Oral Health
Date applied
29/07/2008
Date assigned
14/08/2008
Last edited
09/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rohaya Megat Abdul Wahab

ORCID ID

Contact details

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

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 measures

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

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

http://www.mosti.gov.my

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

Federal/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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes