Orthodontic Appliance ComplicationNCT05929391
Effectiveness of Methods to Remove Residual Orthodontic Adhevsie
A study testing Recycling orthodontic brackets in people with Orthodontic Appliance Complication, run by University of Baghdad at 1 site in Iraq.
Trial summary
The aim of this study is to compare the clinical efficacy of different residual orthodontic adhesive removing methods for rebonding debonded metal attachments. Read more about this study
- Who is it for?
- Ages 12 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliance Complication
- What is being tested?
- Recycling orthodontic brackets
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIraq
- Study dates
- 1 May 2023to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- patients have crown, missing teeth, or craniofacial anomalies.
- patients have congenital enamel defects specially their buccal surface.
Trial locations and contacts
1 site in 1 country.
Iraq1 site
2 private dental clinics in Iraq and special center in Karbala.
Baghdad
About this study
Official title: The Effectiveness of Methods for Removing Residual Orthodontic Adhesive From Debonded Metal Attachments: A Randomized Clinical Trial
The aim of this study is to compare the clinical efficacy of different residual orthodontic adhesive removing methods for rebonding debonded metal attachments.
Read the detailed description
- 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.
- To evaluate and compare the bond failure rates of rebonded brackets between different quadrants and arches.
- 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.
- To evaluate and compare the bond failure rates of rebonded molar tubes between different quadrants and arches.
- Conditions
- Orthodontic Appliance Complication
- Being tested
- Recycling orthodontic brackets
- Keywords
- Recycling, Sandblasting, Metal Bracket.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recycling orthodontic bracketsProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| sandblasted group (T1) | Experimental | the side of mouth patient that receives fixed orthodontic appliance that renewed by sandblast Receives: Procedure: Recycling orthodontic brackets |
| control group (T3) | Placebo comparator | the side of mouth patient that receives new fixed orthodontic appliance. Receives: Procedure: Recycling orthodontic brackets |
| tungsten bur group (T0) | Experimental | the side of mouth patient that receives fixed orthodontic appliance that renewed by tungsten bur. Receives: Procedure: Recycling orthodontic brackets |
| control group (T2) | Placebo comparator | the side of mouth patient that receives new fixed orthodontic appliance. Receives: Procedure: Recycling orthodontic brackets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baselines
Secondary outcomes (1)
The bonding failure between each quadrant will be compared by one way ANOVA.
evaluate and compare the bond failure rates. different quadrants and arches.
Measured: bsaelines
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 May 2023
- Primary completion1 Feb 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Orthodontic Appliance ComplicationStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- split-mouth, cross-quadrant
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saja Saeed Mutar, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929391
- Sponsor's protocol ID
- recycling orthodontic
- Status last verified
- Jul 2024
- First submitted
- 8 Jun 2023
- Last updated
- 8 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30369810Alessandri 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.
PubMed 22051490Eminkahyagil 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.
PubMed 16539561
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Methods for Removing Residual Orthodontic Adhesive From Debonded Metal Attachments: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05929391
- Acronym / sponsor ID
- recycling orthodontic
- Conditions
- Orthodontic Appliance Complication
- Keywords
- Recycling, Sandblasting, Metal Bracket.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- To evaluate and compare the bond failure rates of rebonded brackets between different quadrants and arches.
- 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.
- To evaluate and compare the bond failure rates of rebonded molar tubes between different quadrants and arches.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
- Model description
- split-mouth, cross-quadrant
| Arm | Type | Receives |
|---|---|---|
| sandblasted group (T1) | Experimental | Procedure: Recycling orthodontic bracketsthe side of mouth patient that receives fixed orthodontic appliance that renewed by sandblast |
| control group (T3) | Placebo comparator | Procedure: Recycling orthodontic bracketsthe side of mouth patient that receives new fixed orthodontic appliance. |
| tungsten bur group (T0) | Experimental | Procedure: Recycling orthodontic bracketsthe side of mouth patient that receives fixed orthodontic appliance that renewed by tungsten bur. |
| control group (T2) | Placebo comparator | Procedure: Recycling orthodontic bracketsthe side of mouth patient that receives new fixed orthodontic appliance. |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- patients have crown, missing teeth, or craniofacial anomalies.
- patients have congenital enamel defects specially their buccal surface.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recycling orthodontic bracketsT0: 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. | Procedure or surgery | control group (T2), control group (T3), sandblasted group (T1), tungsten bur group (T0) |
Primary outcome
The number of bonding failures will be compared using the chi-square test.
Time frame: baselines
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.
1 secondary outcome
The bonding failure between each quadrant will be compared by one way ANOVA.
Time frame: bsaelines
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Background: PubMed 30369810Ahmed 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.
- Background: PubMed 22051490Alessandri 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.
- Background: PubMed 16539561Eminkahyagil 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recycling orthodontic brackets in people with Orthodontic Appliance Complication, run by University of Baghdad at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of bonding failures will be compared using the chi-square test. (time frame: baselines). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05929391, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.