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Nano Composites and Light Cure Composites - A Comparative Assessment of Bond Failure Rates

NCT ID: NCT05644860

Last Updated: 2022-12-09

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-06-30

Brief Summary

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This randomized clinical trial is aimed to evaluate the bond failure rates of the brackets bonded with nano-hybrid composites (Filtek Z250) to that of conventional composites (Transbond XT)

Detailed Description

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Orthodontic brackets are attached to the teeth with a robust bonding material called composite resin, however sometimes the bond between the braket and the tooth surface may fail halting the desired tooth movement. Repeated bond failures like these are inconvenience both for the orthodontists as well as the patients. With each bracket loosening due to bond failure, treatment time is prolonged as the activation planned on eash visit is delayed resuling in increased treatment time.

Nanotechnology has recently made a breakthrough in dental materials through incorporation of nanoparticles. Composites containing nano-filler particles exhibit higher compression strength, flexural strength, elastic modulus and wear resistance (Rabia and Bilal). In vitro studies have shown that nanohbrid composites have shear bond stregnths similar to that of conventional composites however the environment of oral cavity is challenging and there are no long term clinical trials to validate these results.

The aim of this study is to compare the rate of bond failure between the brackets bonded with nano hybrid composites and that of the conventional composites over a period of six months.

Conditions

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Nanotechnology, Dental Materials, Composites

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The patients meeting the slection criteria chall be randomly allocated in two groups (A and B)/ Brackets in the group A shall be bonded with the conventional composite (Transbond XT, 3M Unitek, USA) with appreciably good shear bond strength. In patients belonging to group B, brackets shall be bonded with nanohybrid composite (Filtek Z250).

Long term succes shall be evaluated by comparing the bracket failute rate between the two groups.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
The two materials being compared look similar and according to the manufacturers' instructions they are applied using a similar protocol i.e. enamel conditioning, application of unfilled resin, placement of brackets and light curing. Hence the patient will not be able to identify as to which experimental group they are placed in.

Study Groups

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Conventional Composite Group (Transbond XT)

Patients in which brackets will be bonded with conventional composite resin (Transbond XT)

Group Type ACTIVE_COMPARATOR

Conventional Composite Group (Transbond XT)

Intervention Type COMBINATION_PRODUCT

Patients in which brackets will be bonded with conventional composite resin (Transbond XT)

Nanohybrid Compisite Group (Filtek Z250)

Patients in which brackets will be bonded with nanohybrid composite resin (Filtek Z250)

Group Type EXPERIMENTAL

Nanohybrid Compisite Group (Filtek Z250)

Intervention Type COMBINATION_PRODUCT

Orthodontic brackets shall be bonded with Nano hybrid composite

Interventions

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Nanohybrid Compisite Group (Filtek Z250)

Orthodontic brackets shall be bonded with Nano hybrid composite

Intervention Type COMBINATION_PRODUCT

Conventional Composite Group (Transbond XT)

Patients in which brackets will be bonded with conventional composite resin (Transbond XT)

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

* Patients having treatment with fixed metallic orthodontic appliances
* Patients in whom both upper and lower arches are bonded in single visit

Exclusion Criteria

* Patients with variations in morphology of teeth
* Patients with defective enamel, dentine and cementum
* Patiens with parafunctioal habits
* Patients with restorations involving the facial surface of teeth
Minimum Eligible Age

12 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Foundation University Islamabad

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Foundation University Islamabad

Islamabad, Islamabad/ Federal, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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FUI/CTR/2022/19

Identifier Type: -

Identifier Source: org_study_id