Clinical trial NCT05929391: Effectiveness of Methods to Remove Residual Orthodontic Adhevsie
Official title: The Effectiveness of Methods for Removing Residual Orthodontic Adhesive From Debonded Metal Attachments: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontic Appliance Complication
Keywords: Recycling, Sandblasting, Metal Bracket.
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: split-mouth, cross-quadrant
Primary purpose: SCREENING

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.

Detailed description: 1. To evaluate and compare the bond failure rates of rebonded brackets using two methods to remove the adhesive remnant and comparing them with contralateral teeth.
2. To evaluate and compare the bond failure rates of rebonded brackets between different quadrants and arches.
3. To evaluate and compare the bond failure rates of rebonded molar tubes using two methods to remove the adhesive remnant and comparing them with contralateral teeth.
4. To evaluate and compare the bond failure rates of rebonded molar tubes between different quadrants and arches.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: The number of bonding failures will be compared using the chi-square test.
timeFrame: baselines
Secondary outcomes:
measure: The bonding failure between each quadrant will be compared by one way ANOVA.
timeFrame: bsaelines
Other outcomes:
Locations:
city: Baghdad.
country: Iraq
facility: 2 private dental clinics in Iraq and special center in Karbala.
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.