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

• Sponsor: University of Baghdad (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05391386
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 13.4
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Molar Tube Bonding	Procedure: modified bonding technique	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Evaluation of Failure Rate of Molar Tube With a Modified Bonding Technique: A Randomized Clinical Trial
• Actual Study Start Date: Jan 15, 2022
• Anticipated Primary Completion Date: Feb 18, 2023
• Anticipated Study Completion Date: Feb 28, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. failure rate of molar tubes [9 months]

   measuring failure rate of molar tubes bonded with modified bonding technique

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

1. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Almina Dental Clinic	Karbala		Iraq

Sponsors and Collaborators

• University of Baghdad

Investigators

• Principal Investigator: nawar m hasan, BDS, MSc student

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• Vale E Nascimento AÉ, 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.

• Responsible Party: Nawar Mohammed Hasan, Principal Investigator, University of Baghdad
• ClinicalTrials.gov Identifier: NCT05391386
• Other Study ID Numbers: 601422
• First Posted: May 26, 2022
• Last Update Posted: Jun 1, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Nawar Mohammed Hasan, Principal Investigator, University of Baghdad: molar tube; failure rate

Study Results

No Results Posted as of Jun 1, 2022