Dental BondingNCT05345379
A Clinical Comparison of the Effectiveness of Two Moisture Insensitive Primers on Orthodontic Attachment Bond
A study testing Single intervention in people with Dental Bonding, run by University of Baghdad at 1 site in Iraq.
Trial summary
A single-operator, randomized controlled trial (RCT) will be conducted to evaluate the clinical effectiveness of moisture insensitive primers (MIPs) in bonding molar tubes under moisture contaminated conditions by comparing the clinical bond failure and survival rate of molar tubes using two MIPs which are Transbond ™… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dental Bonding
- What is being tested?
- Single intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteIraq
- Study dates
- 11 Apr 2022to Dec 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients seeking for metal fixed orthodontic appliance with 0.22"*0.28";
- Complete set of permanent dentition with fully erupted molar teeth on both arches;
- Intact 1st molars and mainly their buccal surfaces are free from caries, fillings, or gingival hyperplasia;
Who cannot join
- Patients with systemic problem or genetic syndrome that affecting enamel surface like patients with generalized enamel hypoplasia.
- Patients exhibit parafunctional habits;
- Patients who their treatment plan need appliance that soldered on molar bands.
- No occlusal interferences that can affect the ideal position of molar tubes, especially in the lower arch.
Trial locations and contacts
1 site in 1 country.
Ahmed A Abduljawad, B.D.S contact
Iraq1 site, 1 recruiting
- Recruiting
Baghdad college of dentistry
Baghdad, 10047
Ahmed A Abduljawad, B.D.S, +9647705429007 ext. +964, ahmed.abdallah1203a@codental.uobaghdad.edu.iq
Harra S Abdulameer, B.D.S, PhD, +9647904546371 ext. +964, Dr.HarraaS.MS@gmail.com
About this study
Official title: A Clinical Comparison of the Effectiveness of Two Moisture Insensitive Primers on Orthodontic Attachment Bond: A Randomized Clinical Trial
A single-operator, randomized controlled trial (RCT) will be conducted to evaluate the clinical effectiveness of moisture insensitive primers (MIPs) in bonding molar tubes under moisture contaminated conditions by comparing the clinical bond failure and survival rate of molar tubes using two MIPs which are Transbond ™ MIP (3M Unitek Dental Products, Monrovia, CA, USA) and Assure® Plus-All Surface Light Cure Bonding Primer (Reliance, Itasca, IL, USA).
Read the detailed description
A single-operator, a multi-centre, a split-mouth, cross-quadrant RCT, with 1:1 allocation ratio will be conducted for patients seeking for orthodontic treatment with fixed orthodontic appliance. The study will be conducted at postgraduate Orthodontic Clinic/ College of Dentistry/University of Baghdad in addition to private dental clinics in Baghdad, Iraq. Patients seeking for orthodontic treatment and their treatment will be planned with metal fixed orthodontic appliance (0.22" for both arches) will be recruited for this trial. Patients who will met the eligible criteria will be randomly assigned to either group of primer type. A single operator to avoid inter-operator variation will bond all molar tubes. A standardized protocol of tooth preparation and molar tubes bonding will be adopted for all the patients. All teeth will be isolated and cleansed with a mixture of water and pumice using a rubber-polishing cup on a low speed hand piece. The teeth will be rinsed and dried with an oil-free air syringe, and will be etched with the conventional acid etching technique (37% orthophosphoric acid applied for 30sec). They will be subsequently rinsed thoroughly with water for 10sec to ensure total removal of etchant according to the manufacturer's instructions.
Without drying, one coat of the patient own non-stimulated saliva will be applied to the etched and wet surface using bond brush; the excess will be blotted with a moist cotton pellet maintaining the surface moist.
A liberal coat of the MIP will be applied to the etched area of the teeth destined for a specific primer (split-mouth) using a nylon bond brush. Air will be gently blown on each tooth for 2sec, aiming the air stream perpendicular to the enamel surface then light cured for 20sec. After etching and priming, molar tubes will be bonded to the teeth with a light-cured adhesive according to the manufacturer's instructions.
Initial wires will be fitted 10-15mins after bonding completion in the context of the straight wire technique.
All patients will receive the same instructions and will be seen at 3-4-week intervals. They will be, however, requested to inform the operator immediately and attend as soon as possible once a bond failure was apparent. the molar tubes bond survival will be followed up for 6 months. They will be instructed to brush with a manual toothbrush using a fluoride-containing toothpaste.
- Conditions
- Dental Bonding
- Being tested
- Single intervention
- Keywords
- moisture insensitive primers, orthodontic, molar tube, bond failure rate, Assure plus bond, Transbond MIP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single interventionOther
Single intervention at the day of fixed orthodontic appliance bonding
| Study group | Role | What they receive |
|---|---|---|
| Transbond MIP | Experimental | Transbond primer group will be randomly allocated using a split-mouth, cross-quadrant design and two diagonal quadrants (i.e. upper right and lower left, or vice versa) for each participant. Receives: Other: Single intervention |
| Assure plus | Experimental | Assure Plus primer group will be randomly allocated using a split-mouth, cross-quadrant design and two diagonal quadrants (i.e. upper right and lower left, or vice versa) for each participant. Receives: Other: Single intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical bond failure rate
the number of times in which bond failure of molar tubes happens over a period of time (6 months).
Measured: First 6 months
Secondary outcomes (2)
Adhesive remnant index (ARI)
determines the amount of adhesive remaining on the tooth surface when bond failure occurs.
Measured: First 6 months
Bond failure location in the dental arch.
correlations between upper and lower arches and right and left sides with bond failure rate
Measured: First 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start11 Apr 2022
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Dental 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The primers will be randomly allocated using a split-mouth, cross-quadrant design. In each patient, two diagonal quadrants (i.e. upper right and lower left, or vice versa) will be randomly assigned to each primer group.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdulelah Abduljawad, University of Baghdad
- Investigators
- Harraa S Abdulameer, B.D.S, PhD, Study director, Baghdad college of dentistry, Department of orthodonticsAhmed A Abduljawad, B.D.S, Principal investigator, Baghdad college of dentistry, Department of orthodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345379
- Sponsor's protocol ID
- 594422
- Status last verified
- Apr 2022
- First submitted
- 13 Apr 2022
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No Plan to Share IPD because this trial is a prospective study and yet we can't promise for any sharing.
Publications
Zeppieri IL, Chung CH, Mante FK. Effect of saliva on shear bond strength of an orthodontic adhesive used with moisture-insensitive and self-etching primers. Am J Orthod Dentofacial Orthop. 2003 Oct;124(4):414-9. doi: 10.1016/s0889-5406(03)00405-0.
PubMed 14560272Endo T, Ozoe R, Sanpei S, Shinkai K, Katoh Y, Shimooka S. Effects of moisture conditions of dental enamel surface on bond strength of brackets bonded with moisture-insensitive primer adhesive system. Odontology. 2008 Jul;96(1):50-4. doi: 10.1007/s10266-007-0083-7. Epub 2008 Jul 27.
PubMed 18661205Goswami A, Mitali B, Roy B. Shear bond strength comparison of moisture-insensitive primer and self-etching primer. J Orthod Sci. 2014 Jul;3(3):89-93. doi: 10.4103/2278-0203.137695.
PubMed 25143933Paschos E, Westphal JO, Ilie N, Huth KC, Hickel R, Rudzki-Janson I. Artificial saliva contamination effects on bond strength of self-etching primers. Angle Orthod. 2008 Jul;78(4):716-21. doi: 10.2319/0003-3219(2008)078[0716:ASCEOB]2.0.CO;2.
PubMed 18302473Roelofs T, Merkens N, Roelofs J, Bronkhorst E, Breuning H. A retrospective survey of the causes of bracket- and tube-bonding failures. Angle Orthod. 2017 Jan;87(1):111-117. doi: 10.2319/021616-136.1. Epub 2016 Jun 15.
PubMed 27304230Hadrous R, Bouserhal J, Osman E. Evaluation of shear bond strength of orthodontic molar tubes bonded using hydrophilic primers: An in vitro study. Int Orthod. 2019 Sep;17(3):461-468. doi: 10.1016/j.ortho.2019.06.006. Epub 2019 Jul 2.
PubMed 31278045Gange P. The evolution of bonding in orthodontics. Am J Orthod Dentofacial Orthop. 2015 Apr;147(4 Suppl):S56-63. doi: 10.1016/j.ajodo.2015.01.011.
PubMed 25836345
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Comparison of the Effectiveness of Two Moisture Insensitive Primers on Orthodontic Attachment Bond: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05345379
- Acronym / sponsor ID
- 594422
- Conditions
- Dental Bonding
- Keywords
- moisture insensitive primers, orthodontic, molar tube, bond failure rate, Assure plus bond, Transbond MIP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 25 Apr 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.
A single-operator, randomized controlled trial (RCT) will be conducted to evaluate the clinical effectiveness of moisture insensitive primers (MIPs) in bonding molar tubes under moisture contaminated conditions by comparing the clinical bond failure and survival rate of molar tubes using two MIPs which are Transbond ™ MIP (3M Unitek Dental Products, Monrovia, CA, USA) and Assure® Plus-All Surface Light Cure Bonding Primer (Reliance, Itasca, IL, USA).
Detailed description
A single-operator, a multi-centre, a split-mouth, cross-quadrant RCT, with 1:1 allocation ratio will be conducted for patients seeking for orthodontic treatment with fixed orthodontic appliance. The study will be conducted at postgraduate Orthodontic Clinic/ College of Dentistry/University of Baghdad in addition to private dental clinics in Baghdad, Iraq. Patients seeking for orthodontic treatment and their treatment will be planned with metal fixed orthodontic appliance (0.22" for both arches) will be recruited for this trial. Patients who will met the eligible criteria will be randomly assigned to either group of primer type. A single operator to avoid inter-operator variation will bond all molar tubes. A standardized protocol of tooth preparation and molar tubes bonding will be adopted for all the patients. All teeth will be isolated and cleansed with a mixture of water and pumice using a rubber-polishing cup on a low speed hand piece. The teeth will be rinsed and dried with an oil-free air syringe, and will be etched with the conventional acid etching technique (37% orthophosphoric acid applied for 30sec). They will be subsequently rinsed thoroughly with water for 10sec to ensure total removal of etchant according to the manufacturer's instructions.
Without drying, one coat of the patient own non-stimulated saliva will be applied to the etched and wet surface using bond brush; the excess will be blotted with a moist cotton pellet maintaining the surface moist.
A liberal coat of the MIP will be applied to the etched area of the teeth destined for a specific primer (split-mouth) using a nylon bond brush. Air will be gently blown on each tooth for 2sec, aiming the air stream perpendicular to the enamel surface then light cured for 20sec. After etching and priming, molar tubes will be bonded to the teeth with a light-cured adhesive according to the manufacturer's instructions.
Initial wires will be fitted 10-15mins after bonding completion in the context of the straight wire technique.
All patients will receive the same instructions and will be seen at 3-4-week intervals. They will be, however, requested to inform the operator immediately and attend as soon as possible once a bond failure was apparent. the molar tubes bond survival will be followed up for 6 months. They will be instructed to brush with a manual toothbrush using a fluoride-containing toothpaste.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The primers will be randomly allocated using a split-mouth, cross-quadrant design. In each patient, two diagonal quadrants (i.e. upper right and lower left, or vice versa) will be randomly assigned to each primer group.
| Arm | Type | Receives |
|---|---|---|
| Transbond MIP | Experimental | Other: Single interventionTransbond primer group will be randomly allocated using a split-mouth, cross-quadrant design and two diagonal quadrants (i.e. upper right and lower left, or vice versa) for each participant. |
| Assure plus | Experimental | Other: Single interventionAssure Plus primer group will be randomly allocated using a split-mouth, cross-quadrant design and two diagonal quadrants (i.e. upper right and lower left, or vice versa) for each participant. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients seeking for metal fixed orthodontic appliance with 0.22"*0.28";
- Complete set of permanent dentition with fully erupted molar teeth on both arches;
- Intact 1st molars and mainly their buccal surfaces are free from caries, fillings, or gingival hyperplasia;
Key exclusion criteria (4 listed)
- Patients with systemic problem or genetic syndrome that affecting enamel surface like patients with generalized enamel hypoplasia.
- Patients exhibit parafunctional habits;
- Patients who their treatment plan need appliance that soldered on molar bands.
- No occlusal interferences that can affect the ideal position of molar tubes, especially in the lower arch.
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 |
|---|---|---|
| Single interventionSingle intervention at the day of fixed orthodontic appliance bonding | Other | Assure plus, Transbond MIP |
Primary outcome
Clinical bond failure rate
Time frame: First 6 months
the number of times in which bond failure of molar tubes happens over a period of time (6 months).
2 secondary outcomes
Adhesive remnant index (ARI)
Time frame: First 6 months
Bond failure location in the dental arch.
Time frame: First 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Background: PubMed 14560272Zeppieri IL, Chung CH, Mante FK. Effect of saliva on shear bond strength of an orthodontic adhesive used with moisture-insensitive and self-etching primers. Am J Orthod Dentofacial Orthop. 2003 Oct;124(4):414-9. doi: 10.1016/s0889-5406(03)00405-0.
- Background: PubMed 18661205Endo T, Ozoe R, Sanpei S, Shinkai K, Katoh Y, Shimooka S. Effects of moisture conditions of dental enamel surface on bond strength of brackets bonded with moisture-insensitive primer adhesive system. Odontology. 2008 Jul;96(1):50-4. doi: 10.1007/s10266-007-0083-7. Epub 2008 Jul 27.
- Background: PubMed 25143933Goswami A, Mitali B, Roy B. Shear bond strength comparison of moisture-insensitive primer and self-etching primer. J Orthod Sci. 2014 Jul;3(3):89-93. doi: 10.4103/2278-0203.137695.
- Background: PubMed 18302473Paschos E, Westphal JO, Ilie N, Huth KC, Hickel R, Rudzki-Janson I. Artificial saliva contamination effects on bond strength of self-etching primers. Angle Orthod. 2008 Jul;78(4):716-21. doi: 10.2319/0003-3219(2008)078[0716:ASCEOB]2.0.CO;2.
- Background: PubMed 27304230Roelofs T, Merkens N, Roelofs J, Bronkhorst E, Breuning H. A retrospective survey of the causes of bracket- and tube-bonding failures. Angle Orthod. 2017 Jan;87(1):111-117. doi: 10.2319/021616-136.1. Epub 2016 Jun 15.
- Background: PubMed 31278045Hadrous R, Bouserhal J, Osman E. Evaluation of shear bond strength of orthodontic molar tubes bonded using hydrophilic primers: An in vitro study. Int Orthod. 2019 Sep;17(3):461-468. doi: 10.1016/j.ortho.2019.06.006. Epub 2019 Jul 2.
- Background: PubMed 25836345Gange P. The evolution of bonding in orthodontics. Am J Orthod Dentofacial Orthop. 2015 Apr;147(4 Suppl):S56-63. doi: 10.1016/j.ajodo.2015.01.011.
- Assure plus product pageLink provided by the sponsor.
- Individual participant dataSharing planned: No. No Plan to Share IPD because this trial is a prospective study and yet we can't promise for any sharing.
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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.
Ahmed A Abduljawad, B.D.S contact
Harraa S Abdulameer, B.D.S, PhD study director
Baghdad college of dentistry, Department of orthodontics
Ahmed A Abduljawad, B.D.S principal investigator
Baghdad college of dentistry, Department of orthodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single intervention in people with Dental 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 3 inclusion and 4 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 25 Apr 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 Ahmed A Abduljawad, B.D.S (+9647705429007 ext. +964, ahmed.abdallah1203a@codental.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical bond failure rate (time frame: First 6 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 NCT05345379, which also lists 7 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 25 Apr 2022.