A Clinical Comparison of the Effectiveness of Two Moisture Insensitive Primers on Orthodontic Attachment Bond

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).

Study Overview

• Status: Recruiting
• Conditions: Dental Bonding
• Intervention / Treatment: Other: Single intervention

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 Type: Interventional
• Enrollment (Anticipated): 33
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed A Abduljawad, B.D.S; Phone Number: +964 +9647705429007; Email: ahmed.abdallah1203a@codental.uobaghdad.edu.iq
• Study Contact Backup: Name: Harraa S Abdulameer, B.D.S, PhD; Phone Number: +964 +9647904546371; Email: Dr.HarraaS.MS@gmail.com

Study Locations

• Iraq
  • Baghdad, Iraq, 10047
    • Recruiting
    • Baghdad college of dentistry
    • Contact: Ahmed A Abduljawad, B.D.S; Phone Number: +964 +9647705429007; Email: ahmed.abdallah1203a@codental.uobaghdad.edu.iq
    • Contact: Harra S Abdulameer, B.D.S, PhD; Phone Number: +964 +9647904546371; Email: Dr.HarraaS.MS@gmail.com
    • Principal Investigator: Ahmed A Abduljawad, B.D.S

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transbond MIP; 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.	Other: Single intervention; Single intervention at the day of fixed orthodontic appliance bonding
Experimental: Assure plus; 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.	Other: Single intervention; Single intervention at the day of fixed orthodontic appliance bonding

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical bond failure rate	the number of times in which bond failure of molar tubes happens over a period of time (6 months).	First 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adhesive remnant index (ARI)	determines the amount of adhesive remaining on the tooth surface when bond failure occurs.	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	First 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	correlations of age with bond failure rate	First 6 months
Gender	correlations of gender with bond failure rate	First 6 months

Collaborators and Investigators

• Sponsor: University of Baghdad
• Investigators: Study Director: Harraa S Abdulameer, B.D.S, PhD, Baghdad college of dentistry, Department of orthodontics; Principal Investigator: Ahmed A Abduljawad, B.D.S, Baghdad college of dentistry, Department of orthodontics

Publications and helpful links

General 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.
• Endo 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.
• Goswami 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.
• Paschos 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.
• Roelofs 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.
• Hadrous 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.
• Gange 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.

Helpful Links

• Transbond MIP product page
• Assure plus product page

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2022
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: April 20, 2022
• First Posted (Actual): April 25, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: moisture insensitive primers; orthodontic; molar tube; bond failure rate; Assure plus bond; Transbond MIP
• Other Study ID Numbers: 594422

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No Plan to Share IPD because this trial is a prospective study and yet we can't promise for any sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No