Nano Composites and Light Cure Composites - A Comparative... | NCT05644860

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

NCT05644860

Sponsor

Foundation University Islamabad

Status

Unknown status

Last Update Posted

Dec 9, 2022Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Nanotechnology, Dental Materials, Composites

Interventions

Nanohybrid Compisite Group (Filtek Z250)
Conventional Composite Group (Transbond XT)

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2022Actual

Primary Completion Date

Jun 2023Estimated

Completion Date

Jun 2023Estimated

First Submitted Date

Nov 30, 2022

First Submission Date that Met QC Criteria

Nov 30, 2022

First Posted Date

Dec 9, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2022

Last Update Posted Date

Dec 9, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Conventional Composite Group (Transbond XT)	Active Comparator	Patients in which brackets will be bonded with conventional composite resin (Transbond XT)	Combination Product: Conventional Composite Group (Transbond XT)
Nanohybrid Compisite Group (Filtek Z250)	Experimental	Patients in which brackets will be bonded with nanohybrid composite resin (Filtek Z250)	Combination Product: Nanohybrid Compisite Group (Filtek Z250)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nanohybrid Compisite Group (Filtek Z250)	Combination Product	Orthodontic brackets shall be bonded with Nano hybrid composite	Nanohybrid Compisite Group (Filtek Z250)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bracket failure rate	Number of brackets detached from the tooth surface	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

35 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Foundation University Islamabad		Islamabad	Islamabad/ Federal	45720	Pakistan

Intervention Browse Module

MeSH Terms

ID	Term
C444701	Filtek Z250
C477790	Transbond XT

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

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.

Masking Info

Masking

Single

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.

Who Masked

Participant