- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07617480
Comparison of Orthodontic Bracket Bond Failure Using Acid Etching With or Without Sandblasting (AE SBE BF BB)
Comparison of Orthodontic Bracket Bond Failure Using Acid Etching With or Without Sandblasting Method for the Preparation of Enamel
The goal of this clinical trial is to assess if sandblasting before acid etching reduce orthodontic bracket bond failure in fixed orthodontic treatment. The main question it aims to answer is:
• What are the differences in bracket bond failure rate between acid etching with or without sandblasting method for the preparation of enamel? Researchers will compare acid etching with sandblasting method to acid etching without sandblasting method for enamel preparation to see if sandblasting prior to acid etching reduce bracket bond failure rate.
Participants will:
- Receive sandblasting of enamel before acid etching on one side of the mouth and only acid etching on the contralateral side for enamel preparation.
- Participants would visit at the the OPD of Hospital at 3 weeks interval for follow up and for a total duration of 4 months to assess the changes. The number of bracket bond dislodgements at each session will be recorded .
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Dhaka, Bangladesh, 1000
- Bangladesh Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants with good general health condition and oral hygiene status.
- Age range of the patients will be 18 years and above.
- Sex of the participants will be both male and female.
- Patients with full permanent dentition present (excluding 3rd molar).
- Patients with enamel integrity, absence of traumatic or carious lesion.
- Participants who had no enamel pretreatment procedure performed with chemical agents.
- Participants with no crossbite, scissor bite or occlusal interference (to prevent any potential early bond failure).
Exclusion Criteria:
- Patients who have congenital enamel defects,
- Patients who are in need of orthognathic surgery.
- Patients with craniofacial syndromes.
- Patients who present with partially erupted teeth with hypoplasia.
- Patients for whom a rapid expander or a fixed functional appliance will be planned.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Sandblasting
Sandblasting will be applied onto the vestibular surfaces of the teeth before applying the etchant
|
Sandblasting will be applied onto the vestibular surfaces of the teeth before applying the etchant;
|
|
Active Comparator: Acid Etching Alone
Only acid etching will be applied onto the vestibular surfaces of the teeth for enamel preparation.
|
Acid etching will be applied onto the vestibular surfaces of the teeth for enamel preparation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To compare the bracket bond failure rate using acid etching with or without sandblasting method for the preparation of enamel.
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mahmood Sajedeen, BDS, FCPS, Bangladesh Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BMU/2026/1641 (Other Identifier: Bangladesh Medical University (BMU))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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