Evaluation of the Sandblasting on the Rebonding Strength

October 25, 2020 updated by: Damascus University

Evaluation of the Effectiveness of Enamel Surface Treatment Using Sandblasting on the Bond Strength in the Rebonding Process: a Randomized Controlled Trial

Patients at the Orthodontic Department of University of Aleppo Dental School will be selected if they meet the inclusion criteria then fixed orthodontic treatment with 0.018-inch slot MBT appliances will be applied for those patients.

The aim of this study is to compare Two rebonding procedures by applying a split-mouth design. The clinical failure rates of the two rebonding procedures will be evaluated.

Study Overview

Detailed Description

The sample of this study will be chosen after examination of patients referred to the Department of Orthodontics at the University of Aleppo Dental School then subjects who meet the inclusion criteria will be included in this trial.

An information sheet will be given to each possible candidate. Then consent forms will be obtained.

All patients will receive both rebonding procedures by applying split-mouth design. Each patient will be asked to select an opaque sealed envelope from a box with 20 ones. Ten envelopes will Include instructions for applying sandblasting prior to acid-etching on the right upper premolars and acid-etching alone on the left upper premolars. In contrast, the other ten envelopes will include opposite instructions.

A total sample of 80 premolars will be obtained to study the clinical failure rates of the two rebonding procedures.

The 80 premolars will be randomly divided into two groups:

  • The first group in which the enamel will be prepared using sandblasting prior to acid-etching.
  • The second group in which the enamel will be prepared using acid-etching alone.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Aleppo, Syrian Arab Republic, Al88 74TR
        • Department of Orthodontics, University of Aleppo Dental School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. good general health and oral hygiene
  2. willing and able to comply with the trial procedures
  3. No crossbite, scissor bite, or occlusal interferences with the bonded/rebonded brackets in the premolars region (to prevent any potential early bond failure)
  4. no craniofacial anomalies.

Exclusion Criteria:

  1. any type of pervious orthodontic therapy
  2. any need for ortho-surgical treatment or teeth extraction.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sandblasting
The enamel surfaces will be subjected to sandblasting prior to acid etching
Sandblasting will be applied onto the vestibular surfaces of the teeth before applying the etchant.
Active Comparator: Acid Etching Alone
Acid etching will be applied alone before the rebounding procedures
Only acid etching will be applied onto the vestibular surfaces of the teeth before rebonding

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bonding Failure Rate
Time Frame: After six month exactly of bonding the brackets onto the surfaces of the teeth
Number of brackets loosing their bond to the enamel during the observation period divided by the total number of braces being applied.
After six month exactly of bonding the brackets onto the surfaces of the teeth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ahmad Rami Dirie, DDS MSc, Specialist and Clinical Lecturer, Department of Orthodontics, University of Aleppo
  • Principal Investigator: Heba M. Al-Ibrahim, DDS, MSc student in Orthodontics, University of Damascus
  • Study Director: Jamal Dabbas, DDS MSc PhD, Professor of Orthodontics, Department of Orthodontics, University of Aleppo
  • Study Director: Mohammad Y Hajeer, DDS MSc PhD, Professor of Orthodontics, Department of Orthodontics, University of Damascus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2011

Primary Completion (Actual)

May 10, 2012

Study Completion (Actual)

June 15, 2012

Study Registration Dates

First Submitted

October 25, 2020

First Submitted That Met QC Criteria

October 25, 2020

First Posted (Actual)

October 28, 2020

Study Record Updates

Last Update Posted (Actual)

October 28, 2020

Last Update Submitted That Met QC Criteria

October 25, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • UADS-2020-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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