Evaluation of Failure Rate of Molar Tube With a Modified Bonding Technique

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.

Study Overview

• Status: Recruiting
• Conditions: Molar Tube Bonding
• Intervention / Treatment: Procedure: modified bonding technique

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: nawar M hasan, BDS; Phone Number: +9647740366329; Email: Nawwar.mohammed1203a@codental.uobaghdad.edu.iq
• Study Contact Backup: Name: yassir A yassir, Phd; Phone Number: +9647703919599; Email: y.yassir@codental.uobaghdad.edu.iq

Study Locations

• Iraq
  • Karbala, Iraq
    • Recruiting
    • Almina Dental Clinic
    • Contact: Raoof R toma, MSc; Phone Number: +9647706002266; Email: rawof.r@uokerbal.edu.iq

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients requiring fixed appliance orthodontic treatment (with no previous orthodontic treatment).
2. Patients aged >12 years with full permanent dentition (excluding third molars).

3. 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.
4. Patients who have the desire and ability to comply with the trial protocol.

Exclusion Criteria:

1. Treatments with planned extraction of first permanent molars.
2. Occlusal interference that prevents correct position of molar tube.
3. Patients with a craniofacial anomaly (like cleft lip and palate) and/or require orthognathic surgery.
4. Patients that require extra-oral or intra-oral anchorage device (headgear, palatal arch, lingual arch) or expander (quad-helix, hyrax).
5. Lack of consent to participate in the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: conventional
Experimental: modified	Procedure: modified bonding technique; adding a layer of compomer adhesive at the molar/tube interface.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
failure rate of molar tubes	measuring failure rate of molar tubes bonded with modified bonding technique	9 months

Collaborators and Investigators

• Sponsor: University of Baghdad
• Investigators: Principal Investigator: nawar m hasan, BDS, MSc student

Publications and helpful links

General 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.
• Pinzan-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.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2022
• Primary Completion (Anticipated): February 18, 2023
• Study Completion (Anticipated): February 28, 2023

Study Registration Dates

• First Submitted: May 21, 2022
• First Submitted That Met QC Criteria: May 21, 2022
• First Posted (Actual): May 26, 2022

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 26, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: molar tube; failure rate
• Other Study ID Numbers: 601422

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No