Orthodontic TreatmentNCT03187483
Flash-free Brackets and Dental Plaque
A study testing orthodontic treatment in people with Orthodontic Treatment, run by Ege University.
Trial summary
This study aimed to compare flash-free bracket system with conventional adhesive-coated bracket system in patients with maxillary crowding. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Treatment
- What is being tested?
- orthodontic treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Sep 2014
- 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 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- being systemically healthy
- having 4-7 mm maxillary crowding with a maximum of 2 mm linear displacement of contact points and non-extraction treatment planning.
Who cannot join
- -
About this study
Official title: Do Adhesive Flash-free Brackets Affect Bacterial Plaque? A Randomized Controlled Clinical and Microbiological Assessment
This study aimed to compare flash-free bracket system with conventional adhesive-coated bracket system in patients with maxillary crowding.
Read the detailed description
Aim: The aim of this split-mouth study was to compare conventional and adhesive flash-free-bracket systems in terms of plaque retention, white spot lesion formation, biomarker levels and select microbes in gingival crevicular fluid (GCF).
Materials \& Methods: Thirty-seven systemically healthy patients (18 males, 19 females) with the age range of 13-18 years were involved in this split-mouth study. Clinical evaluations, quantitative light-induced fluorescence (QLF) imaging, GCF and plaque samplings were performed at baseline and at 1-, 2-, 3-months. QLF was repeated following debonding, GCF samples were analyzed by immunoassay and real-time PCR for the biomarker and bacteria content. Data were analyzed by Wilcoxon on dependent samples.
- Conditions
- Orthodontic Treatment
- Being tested
- orthodontic treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orthodontic treatmentProcedure or surgery
orthodontic treatment in maxillary crowding
| Study group | Role | What they receive |
|---|---|---|
| Flash-free bracket group | Active comparator | Orthodontic treatment with flash-free bracket system Receives: Procedure: orthodontic treatment |
| Control | Active comparator | Orthodontic treatment with conventional adhesive-coated brackets Receives: Procedure: orthodontic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
development of white spot lesion (WSL)
WSL is the first sign of caries
Measured: 1 month
Secondary outcomes (2)
plaque accumulation around the brackets
plaque deposits cause gingival inflammation
Measured: 1 month
microbial composition around the brackets
presence of pathogen bacteria is important
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study startJan 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic TreatmentStudies of the same condition, open and under way.
- 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurcan Buduneli, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187483
- Sponsor's protocol ID
- 13-11.1/9
- Status last verified
- Jun 2017
- First submitted
- 10 Jun 2017
- Last updated
- 15 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Adhesive Flash-free Brackets Affect Bacterial Plaque? A Randomized Controlled Clinical and Microbiological Assessment
- ClinicalTrials.gov ID
- NCT03187483
- Acronym / sponsor ID
- 13-11.1/9
- Conditions
- Orthodontic Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 15 Jun 2017 (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 study aimed to compare flash-free bracket system with conventional adhesive-coated bracket system in patients with maxillary crowding.
Detailed description
Aim: The aim of this split-mouth study was to compare conventional and adhesive flash-free-bracket systems in terms of plaque retention, white spot lesion formation, biomarker levels and select microbes in gingival crevicular fluid (GCF).
Materials \& Methods: Thirty-seven systemically healthy patients (18 males, 19 females) with the age range of 13-18 years were involved in this split-mouth study. Clinical evaluations, quantitative light-induced fluorescence (QLF) imaging, GCF and plaque samplings were performed at baseline and at 1-, 2-, 3-months. QLF was repeated following debonding, GCF samples were analyzed by immunoassay and real-time PCR for the biomarker and bacteria content. Data were analyzed by Wilcoxon on dependent samples.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flash-free bracket group | Active comparator | Procedure: orthodontic treatmentOrthodontic treatment with flash-free bracket system |
| Control | Active comparator | Procedure: orthodontic treatmentOrthodontic treatment with conventional adhesive-coated brackets |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- being systemically healthy
- having 4-7 mm maxillary crowding with a maximum of 2 mm linear displacement of contact points and non-extraction treatment planning.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| orthodontic treatmentorthodontic treatment in maxillary crowding | Procedure or surgery | Control, Flash-free bracket group |
Primary outcome
development of white spot lesion (WSL)
Time frame: 1 month
WSL is the first sign of caries
2 secondary outcomes
plaque accumulation around the brackets
Time frame: 1 month
microbial composition around the brackets
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing orthodontic treatment in people with Orthodontic Treatment, run by Ege University.
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 1 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: finished, as of the sponsor's last update on 15 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
development of white spot lesion (WSL) (time frame: 1 month). 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 15 Jun 2017.