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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05644860
Enrollment
40
Registered
2022-12-09
Start date
2022-09-01
Completion date
2023-06-30
Last updated
2022-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nanotechnology, Dental Materials, Composites

Brief summary

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

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.

Interventions

COMBINATION_PRODUCTNanohybrid Compisite Group (Filtek Z250)

Orthodontic brackets shall be bonded with Nano hybrid composite

COMBINATION_PRODUCTConventional Composite Group (Transbond XT)

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

Sponsors

Foundation University Islamabad
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
12 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Bracket failure rate6 monthsNumber of brackets detached from the tooth surface

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026