NCT05929391

Brief Summary

The aim of this study is to compare the clinical efficacy of different residual orthodontic adhesive removing methods for rebonding debonded metal attachments.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 8, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

July 8, 2024

Status Verified

July 1, 2024

Enrollment Period

9 months

First QC Date

June 8, 2023

Last Update Submit

July 5, 2024

Conditions

Keywords

Recycling, Sandblasting, Metal Bracket.

Outcome Measures

Primary Outcomes (1)

  • The number of bonding failures will be compared using the chi-square test.

    evaluate and compare the bond failure rates. different quadrants and arches.To evaluate and compare the bond failure rates of rebonded attachments(brackets and molar tubes)using two methods (Tungsten carbide bur and sandblasting)) to remove the adhesive remnant and comparing them with contralateral teeth.

    baselines

Secondary Outcomes (1)

  • The bonding failure between each quadrant will be compared by one way ANOVA.

    bsaelines

Study Arms (4)

sandblasted group (T1)

EXPERIMENTAL

the side of mouth patient that receives fixed orthodontic appliance that renewed by sandblast

Procedure: Recycling orthodontic brackets

control group (T3)

PLACEBO COMPARATOR

the side of mouth patient that receives new fixed orthodontic appliance.

Procedure: Recycling orthodontic brackets

tungsten bur group (T0)

EXPERIMENTAL

the side of mouth patient that receives fixed orthodontic appliance that renewed by tungsten bur.

Procedure: Recycling orthodontic brackets

control group (T2)

PLACEBO COMPARATOR

the side of mouth patient that receives new fixed orthodontic appliance.

Procedure: Recycling orthodontic brackets

Interventions

T0: The adhesive removal will be performed by high-speed hand piece with tungsten carbide bur. the bur will be changed every five attachments. T1: Control group of T0. T2: The adhesive removal will be performed by sandblasting via Micro-etcher. T3: Control group of T2.

control group (T2)control group (T3)sandblasted group (T1)tungsten bur group (T0)

Eligibility Criteria

Age12 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients need metal fixed orthodontic appliance treatment;
  • Complete set of permanent dentition with fully erupted teeth on both arches;
  • Intact teeth and mainly their buccal surfaces are free from caries, fillings, or gingival hyperplasia;
  • No occlusal interferences that can affect the ideal position of attachments, especially in the lower arch.

You may not qualify if:

  • patients have crown, missing teeth, or craniofacial anomalies.
  • patients have congenital enamel defects specially their buccal surface.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2 private dental clinics in Iraq and special center in Karbala.

Baghdad, Iraq

Location

Related Publications (3)

  • Ahmed T, Rahman NA, Alam MK. Assessment of in vivo bond strength studies of the orthodontic bracket-adhesive system: A systematic review. Eur J Dent. 2018 Oct-Dec;12(4):602-609. doi: 10.4103/ejd.ejd_22_18.

    PMID: 30369810BACKGROUND
  • Alessandri Bonetti G, Zanarini M, Incerti Parenti S, Lattuca M, Marchionni S, Gatto MR. Evaluation of enamel surfaces after bracket debonding: an in-vivo study with scanning electron microscopy. Am J Orthod Dentofacial Orthop. 2011 Nov;140(5):696-702. doi: 10.1016/j.ajodo.2011.02.027.

    PMID: 22051490BACKGROUND
  • Eminkahyagil N, Arman A, Cetinsahin A, Karabulut E. Effect of resin-removal methods on enamel and shear bond strength of rebonded brackets. Angle Orthod. 2006 Mar;76(2):314-21. doi: 10.1043/0003-3219(2006)076[0314:EORMOE]2.0.CO;2.

    PMID: 16539561BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
The attachments will carry out by main investigator who give each side coded key then the attachments will be rebond by blind specialist. The participants will be blinded to group assignment and interventions (double-blinded trial).
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: split-mouth, cross-quadrant
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
College of Dentistry/University of Baghdad

Study Record Dates

First Submitted

June 8, 2023

First Posted

July 3, 2023

Study Start

May 1, 2023

Primary Completion

February 1, 2024

Study Completion

March 1, 2024

Last Updated

July 8, 2024

Record last verified: 2024-07

Locations