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OpenTrials
Completed

NCT Number: NCT04606043

Evaluation of the Sandblasting on the Rebonding Strength

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.

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Key information

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthodontics, University of Aleppo Dental School

Aleppo, Al88 74TR, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Sandblasting

Procedure

Sandblasting will be applied onto the vestibular surfaces of the teeth before applying the etchant.

Acid Etching

Procedure

Only acid etching will be applied onto the vestibular surfaces of the teeth before rebonding

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 28, 2020
Registry last updated
Oct 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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