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

30 Oct 2024

The date of last modification

Oct 30, 2024



Application Summary


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)


Trial Details


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

  • Patients with a history of previous orthodontic treatment
  • Patients having poor oral hygiene
  • Physically or mentally compromised patients who cannot maintain good oral hygiene practices nor maintain safety of brackets
  • Patients with craniofacial anomalies which makes bonding of brackets difficult
  • Patients having incisors, canines and premolar teeth with labial restorations, decalcification, enamel defects and other developmental defects
  • Patients having prosthetic replacement of teeth
  • Patients having teeth which are completely out of arch labially or lingually


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



State of Ethics Review Approval


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 & Sponsor Information


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


Primary study sponsor/organization

National Dental Hospital (Teaching), Sri Lanka

National Dental Hospital (Teaching), Sri Lanka 16 Ward Pl, Colombo 00700
0112 693 106


Secondary study sponsor (If any)







Trial Completion details


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