Ignite Creation Date:
2024-05-06 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05345379
Status:
UNKNOWN
Last Update Posted:
2022-04-25
First Post:
2022-04-13
Brief Title:
A Clinical Comparison of the Effectiveness of Two Moisture Insensitive Primers on Orthodontic Attachment Bond
Sponsor:
University of Baghdad
Organization:
University of Baghdad
Study Overview
Official Title:
A Clinical Comparison of the Effectiveness of Two Moisture Insensitive Primers on Orthodontic Attachment Bond A Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 11 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 DentistryUniversity 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 022 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 manufacturers 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 manufacturers 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
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 manufacturers 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None