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

NCT ID: NCT05391386

Last Updated: 2022-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-15

Study Completion Date

2023-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Molar Tube Bonding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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conventional

Group Type NO_INTERVENTION

No interventions assigned to this group

modified

Group Type EXPERIMENTAL

modified bonding technique

Intervention Type PROCEDURE

adding a layer of compomer adhesive at the molar/tube interface.

Interventions

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modified bonding technique

adding a layer of compomer adhesive at the molar/tube interface.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Baghdad

OTHER

Sponsor Role lead

Responsible Party

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Nawar Mohammed Hasan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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nawar m hasan, BDS

Role: PRINCIPAL_INVESTIGATOR

MSc student

Locations

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Almina Dental Clinic

Karbala, , Iraq

Site Status RECRUITING

Countries

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Iraq

Central Contacts

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nawar M hasan, BDS

Role: CONTACT

+9647740366329

yassir A yassir, Phd

Role: CONTACT

+9647703919599

Facility Contacts

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Raoof R toma, MSc

Role: primary

+9647706002266

References

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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.

Reference Type BACKGROUND
PMID: 25127384 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21437468 (View on PubMed)

Hasan NM, Yassir YA. Evaluation of failure rate of molar tubes with a modified bonding technique: a randomized clinical trial. Eur J Orthod. 2023 Nov 30;45(6):764-772. doi: 10.1093/ejo/cjad029.

Reference Type DERIVED
PMID: 37467348 (View on PubMed)

Other Identifiers

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601422

Identifier Type: -

Identifier Source: org_study_id

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