Home » Trials » SLCTR/2024/034
Effects of pumice prophylaxis on retention of orthodontic brackets in conventional etch and prime system in patients attending Orthodontic clinic, National Dental Hospital (Teaching), Sri Lanka
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SLCTR Registration Number
SLCTR/2024/034
Date of Registration
The date of last modification
Oct 30, 2024
Scientific Title of Trial
Effects of pumice prophylaxis on retention of orthodontic brackets in conventional etch and prime system in patients attending Orthodontic clinic, National Dental Hospital (Teaching), Sri Lanka
Public Title of Trial
Effects of omitting pumice prophylaxis on retention of orthodontic brackets in conventional etch and prime system vs standard care in patients attending the Orthodontic clinic at the National Dental Hospital (Teaching), Sri Lanka; a randomized controlled trial.
Disease or Health Condition(s) Studied
Malocclusion
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1302-3144
Any other number(s) assigned to the trial and issuing authority
EC-24-024 (Faculty of Medicine, Colombo)
What is the research question being addressed?
Does the pumice prophylaxis step in conventional etch and prime system, have an effect on retention of orthodontic brackets without breakages when compared to omitting this step, in patients attending the orthodontic clinic, National Dental Hospital (Teaching), Sri Lanka?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Applicable
Intervention(s) planned
Study setting: Orthodontic clinic, National Dental Hospital (Teaching), Sri Lanka.
Method of randomization: simple randomization.
Intervention group: Plan to omit the pumice prophylaxis step in subjects belonging to the intervention group.
Control group: This group will follow standard practice which includes the pumice prophylaxis step.
Details of the pumice prophylaxis step: Teeth in quadrants will be pumiced using a bristled brush in slow contra angle hand piece and rinsed with water and air dried.
Procedure that both groups will undergo: All the teeth will be isolated and etched with 37% phosphoric acid for 15 seconds. Teeth will be then washed for 10 seconds, air spray wash for 10 seconds and dry thoroughly with oil free compressed air. Bonding of brackets will be done according to the manufacturer’s instructions using Ormco Enlight™ light cure adhesive kit in every patient. Primer will be applied with an applicator and if a tooth surface become contaminated with saliva or blood, the procedure will be redone before bonding brackets. 3M™ 0.022 MBT metal brackets will be bonded on the prepared tooth surface. Then initial NiTi arch wires of size 0.012 will be placed on the same day after confirming that there are no occlusal interferences and will be ligated with elastomeric ligatures.
Inclusion criteria
• Male and female patients receiving fixed appliance with metal brackets on both upper and lower arches • Patients aged 12 years and above • Patients having fully erupted incisors, canines, and premolars
Exclusion criteria
Primary outcome(s)
|
1.
Number of fractured brackets |
[ 6 months after the bond up ] |
Secondary outcome(s)
|
1.
Patient perceived discomfort while performing the bond up among pumice applied teeth vs non-pumice applied teeth on a rating (0 - No discomfort at all to 3- Highest Discomfort). |
[ At the time of bond up ] |
|
2.
Factors associated with bond failure such as age, gender and duration of failure of bracket after the bond up. |
[ At the time of bond up and during the first 6 months. ] |
Target number/sample size
584 teeth in each arm
Countries of recruitment
Sri Lanka
Anticipated start date
2024-11-01
Anticipated end date
2025-05-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Investigator funded
Regulatory approvals
Status
Approved
Date of Approval
2024-07-18
Approval number
EC-24-024
Details of Ethics Review Committee
| Name: | Ethics Review Committee of the Faculty of Medicine, University of Colombo |
| Institutional Address: | Faculty of Medicine, University of Colombo, PO Box 271, Kynsey Road, Colombo 8, Sri Lanka. |
| Telephone: | 0112695300 |
| Email: | info.ethics@med.cmb.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Dr Madhuka Ramanayaka
Senior Registrar in Orthodontics
Post Graduate Institute of Medicine, UOC Colombo.
0112677618
0771654834
madhuka.ramanayaka@gmail.com
Contact Person for Public Queries
Dr Irosha Perera
Consultant in Community Dentistry
Preventive Oral Health Unit,
National Dental Hospital (Teaching) Sri Lanka.
071 4934258
irosha666rukmali@gmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
