Nanotechnology, Dental Materials, CompositesNCT05644860
Nano Composites and Light Cure Composites - A Comparative Assessment of Bond Failure Rates
A study testing Nanohybrid Compisite Group (Filtek Z250) and Conventional Composite Group (Transbond XT) in people with Nanotechnology, Dental Materials, Composites, run by Foundation University Islamabad at 1 site in Pakistan.
Trial 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) Read more about this study
- Who is it for?
- Ages 12 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Nanotechnology, Dental Materials, Composites
- What is being tested?
- Nanohybrid Compisite Group (Filtek Z250) and Conventional Composite Group (Transbond XT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2022to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients having treatment with fixed metallic orthodontic appliances
- Patients in whom both upper and lower arches are bonded in single visit
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Foundation University Islamabad
Islamabad, Islamabad/ Federal, 45720
About this study
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)
Read the 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.
- Being tested
- Nanohybrid Compisite Group (Filtek Z250), Conventional Composite Group (Transbond XT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanohybrid Compisite Group (Filtek Z250)Combination product
Orthodontic brackets shall be bonded with Nano hybrid composite
Conventional Composite Group (Transbond XT)Combination product
Patients in which brackets will be bonded with conventional composite resin (Transbond XT)
| Study group | Role | What they receive |
|---|---|---|
| Conventional Composite Group (Transbond XT) | Active comparator | Patients in which brackets will be bonded with conventional composite resin (Transbond XT) Receives: 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) Receives: Combination Product: Nanohybrid Compisite Group (Filtek Z250) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bracket failure rate
Number of brackets detached from the tooth surface
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start1 Sep 2022
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nanotechnology, Dental Materials, CompositesStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644860
- Sponsor's protocol ID
- FUI/CTR/2022/19
- Status last verified
- Nov 2022
- First submitted
- 30 Nov 2022
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nano Composites and Light Cure Composites - A Comparative Assessment of Bond Failure Rates
- ClinicalTrials.gov ID
- NCT05644860
- Acronym / sponsor ID
- FUI/CTR/2022/19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Conventional Composite Group (Transbond XT) | Active comparator | Combination Product: Conventional Composite Group (Transbond XT)Patients in which brackets will be bonded with conventional composite resin (Transbond XT) |
| Nanohybrid Compisite Group (Filtek Z250) | Experimental | Combination Product: Nanohybrid Compisite Group (Filtek Z250)Patients in which brackets will be bonded with nanohybrid composite resin (Filtek Z250) |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients having treatment with fixed metallic orthodontic appliances
- Patients in whom both upper and lower arches are bonded in single visit
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nanohybrid Compisite Group (Filtek Z250)Orthodontic brackets shall be bonded with Nano hybrid composite | Combination product | Nanohybrid Compisite Group (Filtek Z250) |
| Conventional Composite Group (Transbond XT)Patients in which brackets will be bonded with conventional composite resin (Transbond XT) | Combination product | Conventional Composite Group (Transbond XT) |
Primary outcome
Bracket failure rate
Time frame: 6 months
Number of brackets detached from the tooth surface
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nanohybrid Compisite Group (Filtek Z250) and Conventional Composite Group (Transbond XT) in people with Nanotechnology, Dental Materials, Composites, run by Foundation University Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bracket failure rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2022.