Molar Tube BondingNCT05391386
Evaluation of Failure Rate of Molar Tube With a Modified Bonding Technique
A study testing modified bonding technique in people with Molar Tube Bonding, run by University of Baghdad at 1 site in Iraq.
Trial summary
Comparing between the failure rates of molar tubes bonded with conventional bonding technique using resin adhesive and the alternative bonding technique using compomer (containing glass ionomer) adhesive by adding a layer of compomer adhesive at the molar/tube interface. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Molar Tube Bonding
- What is being tested?
- modified bonding technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIraq
- Study dates
- 15 Jan 2022to 28 Feb 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients requiring fixed appliance orthodontic treatment (with no previous orthodontic treatment).
- Patients aged >12 years with full permanent dentition (excluding third molars).
- Intact buccal enamel surface of the molars without any of the following:
- Caries, abrasion, or any other crown defect (like hypoplasia).
- Pretreatment chemical agents.
- Restorations or fractures.
- Morphological modifications or other crown alterations.
- Patients who have the desire and ability to comply with the trial protocol.
Who cannot join
- Treatments with planned extraction of first permanent molars.
- Occlusal interference that prevents correct position of molar tube.
- Patients with a craniofacial anomaly (like cleft lip and palate) and/or require orthognathic surgery.
- Patients that require extra-oral or intra-oral anchorage device (headgear, palatal arch, lingual arch) or expander (quad-helix, hyrax).
- Lack of consent to participate in the trial.
Trial locations and contacts
1 site in 1 country.
Iraq1 site, 1 recruiting
- Recruiting
Almina Dental Clinic
Karbala
Raoof R toma, MSc, +9647706002266, rawof.r@uokerbal.edu.iq
About this study
Official title: Evaluation of Failure Rate of Molar Tube With a Modified Bonding Technique: A Randomized Clinical Trial
Comparing between the failure rates of molar tubes bonded with conventional bonding technique using resin adhesive and the alternative bonding technique using compomer (containing glass ionomer) adhesive by adding a layer of compomer adhesive at the molar/tube interface.
- Conditions
- Molar Tube Bonding
- Being tested
- modified bonding technique
- Keywords
- molar tube, failure rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified bonding techniqueProcedure or surgery
adding a layer of compomer adhesive at the molar/tube interface.
| Study group | Role | What they receive |
|---|---|---|
| conventional | No intervention | Not described |
| modified | Experimental | Not described Receives: Procedure: modified bonding technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
failure rate of molar tubes
measuring failure rate of molar tubes bonded with modified bonding technique
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start15 Jan 2022
- Primary completion18 Feb 2023 (estimated)
- Study completion28 Feb 2023 (estimated)
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 Molar Tube BondingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nawar Mohammed Hasan, University of Baghdad
- Investigators
- nawar m hasan, BDS, Principal investigator, MSc student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391386
- Sponsor's protocol ID
- 601422
- Status last verified
- May 2022
- First submitted
- 21 May 2022
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vale E Nascimento AE, Bramante FS, Pinzan-Vercelino CR, Pinzan A, Gurgel JA. Resin reinforcement: an alternative approach for direct bonding of molar tubes. J Clin Orthod. 2014 Jul;48(7):436-40. No abstract available.
PubMed 25127384Pinzan-Vercelino CR, Pinzan A, Gurgel Jde A, Bramante FS, Pinzan LM. In vitro evaluation of an alternative method to bond molar tubes. J Appl Oral Sci. 2011 Jan-Feb;19(1):41-6. doi: 10.1590/s1678-77572011000100009.
PubMed 21437468Hasan NM, Yassir YA. Evaluation of failure rate of molar tubes with a modified bonding technique: a randomized clinical trial. Eur J Orthod. 2023 Nov 30;45(6):764-772. doi: 10.1093/ejo/cjad029.
PubMed 37467348
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Failure Rate of Molar Tube With a Modified Bonding Technique: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05391386
- Acronym / sponsor ID
- 601422
- Conditions
- Molar Tube Bonding
- Keywords
- molar tube, failure rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 18 Feb 2023 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 26 May 2022 (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.
Comparing between the failure rates of molar tubes bonded with conventional bonding technique using resin adhesive and the alternative bonding technique using compomer (containing glass ionomer) adhesive by adding a layer of compomer adhesive at the molar/tube interface.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional | No intervention | – |
| modified | Experimental | Procedure: modified bonding technique |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patients requiring fixed appliance orthodontic treatment (with no previous orthodontic treatment).
- Patients aged >12 years with full permanent dentition (excluding third molars).
- Intact buccal enamel surface of the molars without any of the following:
- Patients who have the desire and ability to comply with the trial protocol.
Key exclusion criteria (5 listed)
- Treatments with planned extraction of first permanent molars.
- Occlusal interference that prevents correct position of molar tube.
- Patients with a craniofacial anomaly (like cleft lip and palate) and/or require orthognathic surgery.
- Patients that require extra-oral or intra-oral anchorage device (headgear, palatal arch, lingual arch) or expander (quad-helix, hyrax).
- Lack of consent to participate in the trial.
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 |
|---|---|---|
| modified bonding techniqueadding a layer of compomer adhesive at the molar/tube interface. | Procedure or surgery | modified |
Primary outcome
failure rate of molar tubes
Time frame: 9 months
measuring failure rate of molar tubes bonded with modified bonding technique
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Background: PubMed 25127384Vale E Nascimento AE, Bramante FS, Pinzan-Vercelino CR, Pinzan A, Gurgel JA. Resin reinforcement: an alternative approach for direct bonding of molar tubes. J Clin Orthod. 2014 Jul;48(7):436-40. No abstract available.
- Background: PubMed 21437468Pinzan-Vercelino CR, Pinzan A, Gurgel Jde A, Bramante FS, Pinzan LM. In vitro evaluation of an alternative method to bond molar tubes. J Appl Oral Sci. 2011 Jan-Feb;19(1):41-6. doi: 10.1590/s1678-77572011000100009.
- Derived from this study: PubMed 37467348Hasan NM, Yassir YA. Evaluation of failure rate of molar tubes with a modified bonding technique: a randomized clinical trial. Eur J Orthod. 2023 Nov 30;45(6):764-772. doi: 10.1093/ejo/cjad029.
- Individual participant dataSharing planned: Undecided
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.
nawar m hasan, BDS principal investigator
MSc student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modified bonding technique in people with Molar Tube Bonding, 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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Jun 2022. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact nawar M hasan, BDS (+9647740366329, Nawwar.mohammed1203a@codental.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
failure rate of molar tubes (time frame: 9 months). 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 NCT05391386, 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 1 Jun 2022; AzTrials last refreshed its copy on 8 Nov 2026.