NCT04606043

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2011

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 20, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2012

Completed
8.4 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2020

Completed
Last Updated

October 28, 2020

Status Verified

October 1, 2020

Enrollment Period

11 months

First QC Date

October 25, 2020

Last Update Submit

October 25, 2020

Conditions

Orthodontic Appliance Complication

Outcome Measures

Primary Outcomes (1)

  • Bonding Failure Rate

    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

Study Arms (2)

Sandblasting

EXPERIMENTAL

The enamel surfaces will be subjected to sandblasting prior to acid etching

Procedure: Sandblasting

Acid Etching Alone

ACTIVE COMPARATOR

Acid etching will be applied alone before the rebounding procedures

Procedure: Acid Etching

Interventions

SandblastingPROCEDURE

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

Sandblasting
Acid EtchingPROCEDURE

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

Acid Etching Alone

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthodontics, University of Aleppo Dental School

Aleppo, Al88 74TR, Syria

Location

Related Publications (5)

  • Egan FR, Alexander SA, Cartwright GE. Bond strength of rebonded orthodontic brackets. Am J Orthod Dentofacial Orthop. 1996 Jan;109(1):64-70. doi: 10.1016/s0889-5406(96)70164-6.

    PMID: 8540484BACKGROUND

  • Bishara SE, Laffoon JF, Vonwald L, Warren JJ. The effect of repeated bonding on the shear bond strength of different orthodontic adhesives. Am J Orthod Dentofacial Orthop. 2002 May;121(5):521-5. doi: 10.1067/mod.2002.123042.

    PMID: 12045771BACKGROUND

  • Faust JB, Grego GN, Fan PL, Powers JM. Penetration coefficient, tensile strength, and bond strength of thirteen direct bonding orthodontic cements. Am J Orthod. 1978 May;73(5):512-25. doi: 10.1016/0002-9416(78)90241-5. No abstract available.

    PMID: 354405BACKGROUND

  • Mizrahi E. Success and failure of banding and bonding. A clinical study. Angle Orthod. 1982 Apr;52(2):113-7. doi: 10.1043/0003-3219(1982)0522.0.CO;2.

    PMID: 7049010BACKGROUND

  • Dirie AR, Hajeer MY, Dabbas J, Al-Ibrahim HM. Evaluation of sandblasting with acid etching versus acid etching alone in the preparation of enamel for rebonding orthodontic brackets: An in vitro study and a randomized controlled trial. J World Fed Orthod. 2021 Mar;10(1):3-8. doi: 10.1016/j.ejwf.2020.12.001. Epub 2021 Jan 7.

    PMID: 33422476DERIVED

MeSH Terms

Interventions

Acid Etching, Dental

Intervention Hierarchy (Ancestors)

Dental EtchingTooth PreparationDentistry

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Split-mouth design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2020

First Posted

October 28, 2020

Study Start

June 20, 2011

Primary Completion

May 10, 2012

Study Completion

June 15, 2012

Last Updated

October 28, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

SY(1)