Effectiveness of Methods to Remove Residual Orthodontic Adhevsie
The Effectiveness of Methods for Removing Residual Orthodontic Adhesive From Debonded Metal Attachments: A Randomized Clinical Trial
1 other identifier
interventional
40
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2023
Shorter than P25 for not_applicable
1 active site
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
May 1, 2023
CompletedFirst Submitted
Initial submission to the registry
June 8, 2023
CompletedFirst Posted
Study publicly available on registry
July 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedJuly 8, 2024
July 1, 2024
9 months
June 8, 2023
July 5, 2024
Conditions
Keywords
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)
EXPERIMENTALthe side of mouth patient that receives fixed orthodontic appliance that renewed by sandblast
control group (T3)
PLACEBO COMPARATORthe side of mouth patient that receives new fixed orthodontic appliance.
tungsten bur group (T0)
EXPERIMENTALthe side of mouth patient that receives fixed orthodontic appliance that renewed by tungsten bur.
control group (T2)
PLACEBO COMPARATORthe side of mouth patient that receives new fixed orthodontic appliance.
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.
Eligibility Criteria
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
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: 30369810BACKGROUNDAlessandri 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: 22051490BACKGROUNDEminkahyagil 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
- 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