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

NCT05345379 | Unknown

• 1 other identifier: 594422
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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).

Conditions

Dental Bonding

Keywords

moisture insensitive primers; orthodontic; molar tube; bond failure rate; Assure plus bond; Transbond MIP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Adhesive remnant index (ARI)

  First 6 months

• Bond failure location in the dental arch.

  First 6 months

Other Outcomes (2)

• Age

  First 6 months

• Gender

  First 6 months

Study Arms (2)

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.

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.

Other: Single intervention

Interventions

Single intervention OTHER

Single intervention at the day of fixed orthodontic appliance bonding

Assure plus; Transbond MIP

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

Baghdad college of dentistry

Baghdad, 10047, Iraq

RECRUITING

Related Publications (7)

• 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.

  PMID: 14560272 BACKGROUND

• 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.

  PMID: 18661205 BACKGROUND

• 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.

  PMID: 25143933 BACKGROUND

• 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.

  PMID: 18302473 BACKGROUND

• 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.

  PMID: 27304230 BACKGROUND

• 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.

  PMID: 31278045 BACKGROUND

• 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.

  PMID: 25836345 BACKGROUND

Related Links

• Transbond MIP product page
• Assure plus product page

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Harraa S Abdulameer, B.D.S, PhD

  Baghdad college of dentistry, Department of orthodontics

  STUDY DIRECTOR

• Ahmed A Abduljawad, B.D.S

  Baghdad college of dentistry, Department of orthodontics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed A Abduljawad, B.D.S

CONTACT

+9647705429007; ahmed.abdallah1203a@codental.uobaghdad.edu.iq

Harraa S Abdulameer, B.D.S, PhD

CONTACT

+9647904546371; Dr.HarraaS.MS@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This trial will be triple-blinded in which neither the participants nor the trial team will know which one of the primers a patient has received, as well as the outcome assessor will be blinded. This can be achieved by placing the two primers in two similar masked bottles and giving them numerical coding i.e. number one and number two coding for either type of primer.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: orthodontics master student

Model Details: 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.

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 25, 2022
• Study Start: April 11, 2022
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)