NCT04456114

Brief Summary

To describe a method of acid etching the base of a bracket, and to compare the bond failures between micro-abrasive blasted (sandblasted) brackets and acid etched brackets over an eighteen month period

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
340

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 2, 2020

Completed
Last Updated

July 7, 2020

Status Verified

July 1, 2020

Enrollment Period

1.7 years

First QC Date

June 27, 2020

Last Update Submit

July 2, 2020

Conditions

Orthodontic Appliances

Outcome Measures

Primary Outcomes (1)

  • Bond Failure Rate

    To compare the bond failure rates between acid etched and sandblasted brackets. Done by calculating and comparing the percentages of bracket breakages between the acid etched and sandblasted bracket quadrants.

    18 months after placement of brackets on the teeth

Study Arms (2)

Acid etched brackets

EXPERIMENTAL

Stainless steel bracket base etched with 10% Hydrofluoric acid for 1 minute

Device: Acid etched brackets

Sandblasted brackets

ACTIVE COMPARATOR

Stainless steel bracket sandblasted base

Device: Sandblasted brackets

Interventions

Acid etched bracketsDEVICE

The brackets will be bonded to the teeth with composite on the same patient in a split mouth design and observed for bracket debonding for 18 months

Acid etched brackets
Sandblasted bracketsDEVICE

The brackets will be bonded to the teeth with composite on the same patient in a split mouth design and observed for bracket debonding for 18 months

Sandblasted brackets

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients about to undergo fixed orthodontic therapy

You may not qualify if:

  • Patients with cavities, history of fixed orthodontic therapy, recent bleaching

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Islamic International Dental College

Islamabad, 44000, Pakistan

Location

Study Officials

  • Owais K Durrani, FFDRCSI

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: parallel-group, split mouth, triple blinded, randomized control trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Orthodonitcs

Study Record Dates

First Submitted

June 27, 2020

First Posted

July 2, 2020

Study Start

June 1, 2018

Primary Completion

January 31, 2020

Study Completion

January 31, 2020

Last Updated

July 7, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)