OrthodonticsNCT04185987
Evaluation of the Contamination of Ligatures
A study testing Leone slide low friction elastomeric ligature, RMO tough - o energy elastomeric ligature and Dentsply sili tie elastomeric ligature in people with Orthodontics, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial summary
This crossover, in-vivo study was carried out with 10 patients who have been started to be treated at Orthodontics Department. 3 elastomeric ligatures were examined in terms of microbiological and surface roughness. Read more about this study
- Who is it for?
- Ages 12 to 14 years
- Conditions the study is for
- Orthodontics
- What is being tested?
- Leone slide low friction elastomeric ligature, RMO tough - o energy elastomeric ligature and Dentsply sili tie elastomeric ligature
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Aug 2017to 20 Mar 2018
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- permanent teeth in the mouth
- patients with good oral hygiene
- patients did not use antimicrobial drugs such as antibiotics and mouthwashes 3 weeks before the study period and within the 18-week period covering the study period.
Who cannot join
- smoker
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep University
Gaziantep, Şehitkamil, 27310
About this study
Official title: Evaluation of the Contamination of Elastomeric Ligatures
This crossover, in-vivo study was carried out with 10 patients who have been started to be treated at Orthodontics Department. 3 elastomeric ligatures were examined in terms of microbiological and surface roughness.
Read the detailed description
The development of dental plaque has been associated with several environmental and individual factors including diet composition, oral hygiene, the quality of saliva, the composition of the oral microflora and immune factors. Orthodontic fixed appliances also impede the maintenance of oral hygiene. Plaque accumulation surrounding orthodontic appliances leads to enamel demineralization caused by organic acids produced by bacteria in the dental plaque.
In patients with fixed orthodontic treatment, common pathological changes are gingivitis, bleeding and gingival growth; thus, gingival index and plaque index parameters have been used as indicators of periodontal disease in many studies. Enamel demineralization which results in white spot formation is observed due to the increase in the number and volume of acid-producing bacteria, and the decrease in pH level because of the glucose metabolized by these cariogenic bacteria . The most commonly investigated bacteria among those mentioned above is Streptococcus Mutans. In the literature, it has been the subject of many studies, including those investigating the correlation between the S. mutans count and the amount of adhesive left between brackets and the enamel, adhesion of S. mutans to nickel titanium and copper-nickel brackets, the difference in S. mutans colonization between self-ligation system and normal brackets, and the effect of elastomeric rings and ligature wires on S. mutans colonization.
Non-conventional elastomeric ligatures were produced in order to reduce the friction of orthodontic sliding mechanics. Manufacturers claim that non-conventional elastomeric ligatures reduced ligation friction by 60% compared to conventional modules. It was reported in another study that brackets combined via non-conventional elastomeric ligatures resulted in a reduced friction force compared to conventional elastomeric ligatures in any wires from 14-inch NITI to 19.25 SS.
To our current knowledge, bacterial colonization on non-conventional elastomeric ligatures was investigated in one study only, using microbial culture technique. In light of this information, present study was aimed to compare S. mutans colonization among different commercial types of non-conventional ligatures and ligature wires. The surface structures of these ligature types also will be investigated by atomic force microscope (AFM) and the results of this investigation will be associated with the results of bacterial colonization amount.
- Conditions
- Orthodontics
- Being tested
- Leone slide low friction elastomeric ligature, RMO tough - o energy elastomeric ligature, Dentsply sili tie elastomeric ligature, AO twisted ended ligature wire
- Keywords
- bacterial adhesion, elastomeric ligatures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leone slide low friction elastomeric ligatureOther
Leone slide low friction elastomeric ligature application
RMO tough - o energy elastomeric ligatureOther
RMO tough - o energy elastomeric ligature application
Dentsply sili tie elastomeric ligatureOther
Dentsply sili tie elastomeric ligature application
AO twisted ended ligature wireOther
AO twisted ended ligature wire application
| Study group | Role | What they receive |
|---|---|---|
| Microbial colonisation | Experimental | microbial sample collection was done at the end of the time periods T1 (6 weeks after bonding ), 10 weeks after bonding (T2), 14 weeks after bonding (T3), 18 weeks after bonding (T4) Receives: Other: Leone slide low friction elastomeric ligature; Other: RMO tough - o energy elastomeric ligature; Other: Dentsply sili tie elastomeric ligature; Other: AO twisted ended ligature wire |
| Plaque index | Experimental | Plaque index was measured prior to bonding (T0), 6 weeks after bonding (T1),10 weeks after bonding (T2), 14 weeks after bonding (T3), 18 weeks after bonding (T4) Receives: Other: Leone slide low friction elastomeric ligature; Other: RMO tough - o energy elastomeric ligature; Other: Dentsply sili tie elastomeric ligature; Other: AO twisted ended ligature wire |
| Gingival index | Experimental | Gingival index was measured prior to bonding (T0), 6 weeks after bonding (T1), 10 weeks after bonding (T2), 14 weeks after bonding (T3), 18 weeks after bonding (T4) Receives: Other: Leone slide low friction elastomeric ligature; Other: RMO tough - o energy elastomeric ligature; Other: Dentsply sili tie elastomeric ligature; Other: AO twisted ended ligature wire |
| surface roughness | Experimental | surface roughness was measured before usage and after 4-weeks usage Receives: Other: Leone slide low friction elastomeric ligature; Other: RMO tough - o energy elastomeric ligature; Other: Dentsply sili tie elastomeric ligature; Other: AO twisted ended ligature wire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbial colonisation change of S mutans
Measurement of microbial colonisation change of the interventions with real time PCR
Measured: up to 18 weeks
surface roughness identification with atomic force microscope
measurement of surface roughness identification of the interventions by atomic force microscope
Measured: up to 4 weeks
Secondary outcomes (1)
Plaque index
Measurement of plaque index
Measured: through study completion, 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start10 Aug 2017
- Primary completion20 Jan 2018
- Study completion20 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OrthodonticsStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- 2 a cross-over, in vivo study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysegul Gulec, University of Gaziantep
- Investigators
- Çağlar Dağdeviren, Study chair, University of GaziantepFahriye Ekşi, Study chair, University of GaziantepMustafa sağlam, Study chair, University of GaziantepMehmet Kahraman, Study chair, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185987
- Sponsor's protocol ID
- 2017/169
- Status last verified
- Jul 2020
- First submitted
- 26 Nov 2019
- Last updated
- 16 Jul 2020
- 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 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Contamination of Elastomeric Ligatures
- ClinicalTrials.gov ID
- NCT04185987
- Acronym / sponsor ID
- 2017/169
- Conditions
- Orthodontics
- Keywords
- bacterial adhesion, elastomeric ligatures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 10 Aug 2017 (actual)
- Primary completion
- 20 Jan 2018 (actual)
- Study completion
- 20 Mar 2018 (actual)
- First posted
- 4 Dec 2019 (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 crossover, in-vivo study was carried out with 10 patients who have been started to be treated at Orthodontics Department. 3 elastomeric ligatures were examined in terms of microbiological and surface roughness.
Detailed description
The development of dental plaque has been associated with several environmental and individual factors including diet composition, oral hygiene, the quality of saliva, the composition of the oral microflora and immune factors. Orthodontic fixed appliances also impede the maintenance of oral hygiene. Plaque accumulation surrounding orthodontic appliances leads to enamel demineralization caused by organic acids produced by bacteria in the dental plaque.
In patients with fixed orthodontic treatment, common pathological changes are gingivitis, bleeding and gingival growth; thus, gingival index and plaque index parameters have been used as indicators of periodontal disease in many studies. Enamel demineralization which results in white spot formation is observed due to the increase in the number and volume of acid-producing bacteria, and the decrease in pH level because of the glucose metabolized by these cariogenic bacteria . The most commonly investigated bacteria among those mentioned above is Streptococcus Mutans. In the literature, it has been the subject of many studies, including those investigating the correlation between the S. mutans count and the amount of adhesive left between brackets and the enamel, adhesion of S. mutans to nickel titanium and copper-nickel brackets, the difference in S. mutans colonization between self-ligation system and normal brackets, and the effect of elastomeric rings and ligature wires on S. mutans colonization.
Non-conventional elastomeric ligatures were produced in order to reduce the friction of orthodontic sliding mechanics. Manufacturers claim that non-conventional elastomeric ligatures reduced ligation friction by 60% compared to conventional modules. It was reported in another study that brackets combined via non-conventional elastomeric ligatures resulted in a reduced friction force compared to conventional elastomeric ligatures in any wires from 14-inch NITI to 19.25 SS.
To our current knowledge, bacterial colonization on non-conventional elastomeric ligatures was investigated in one study only, using microbial culture technique. In light of this information, present study was aimed to compare S. mutans colonization among different commercial types of non-conventional ligatures and ligature wires. The surface structures of these ligature types also will be investigated by atomic force microscope (AFM) and the results of this investigation will be associated with the results of bacterial colonization amount.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 2 a cross-over, in vivo study.
| Arm | Type | Receives |
|---|---|---|
| Microbial colonisation | Experimental | Other: Leone slide low friction elastomeric ligature, Other: RMO tough - o energy elastomeric ligature, Other: Dentsply sili tie elastomeric ligature, Other: AO twisted ended ligature wiremicrobial sample collection was done at the end of the time periods T1 (6 weeks after bonding ), 10 weeks after bonding (T2), 14 weeks after bonding (T3), 18 weeks after bonding (T4) |
| Plaque index | Experimental | Other: Leone slide low friction elastomeric ligature, Other: RMO tough - o energy elastomeric ligature, Other: Dentsply sili tie elastomeric ligature, Other: AO twisted ended ligature wirePlaque index was measured prior to bonding (T0), 6 weeks after bonding (T1),10 weeks after bonding (T2), 14 weeks after bonding (T3), 18 weeks after bonding (T4) |
| Gingival index | Experimental | Other: Leone slide low friction elastomeric ligature, Other: RMO tough - o energy elastomeric ligature, Other: Dentsply sili tie elastomeric ligature, Other: AO twisted ended ligature wireGingival index was measured prior to bonding (T0), 6 weeks after bonding (T1), 10 weeks after bonding (T2), 14 weeks after bonding (T3), 18 weeks after bonding (T4) |
| surface roughness | Experimental | Other: Leone slide low friction elastomeric ligature, Other: RMO tough - o energy elastomeric ligature, Other: Dentsply sili tie elastomeric ligature, Other: AO twisted ended ligature wiresurface roughness was measured before usage and after 4-weeks usage |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- permanent teeth in the mouth
- patients with good oral hygiene
- patients did not use antimicrobial drugs such as antibiotics and mouthwashes 3 weeks before the study period and within the 18-week period covering the study period.
Key exclusion criteria (1 listed)
- smoker
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 |
|---|---|---|
| Leone slide low friction elastomeric ligatureLeone slide low friction elastomeric ligature application | Other | Gingival index, Microbial colonisation, Plaque index, surface roughness |
| RMO tough - o energy elastomeric ligatureRMO tough - o energy elastomeric ligature application | Other | Gingival index, Microbial colonisation, Plaque index, surface roughness |
| Dentsply sili tie elastomeric ligatureDentsply sili tie elastomeric ligature application | Other | Gingival index, Microbial colonisation, Plaque index, surface roughness |
| AO twisted ended ligature wireAO twisted ended ligature wire application | Other | Gingival index, Microbial colonisation, Plaque index, surface roughness |
Primary outcome
Microbial colonisation change of S mutans
Time frame: up to 18 weeks
Measurement of microbial colonisation change of the interventions with real time PCR
surface roughness identification with atomic force microscope
Time frame: up to 4 weeks
measurement of surface roughness identification of the interventions by atomic force microscope
1 secondary outcome
Plaque index
Time frame: through study completion, 18 weeks
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 16 Jul 2020.
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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.
Çağlar Dağdeviren study chair
University of Gaziantep
Fahriye Ekşi study chair
University of Gaziantep
Mustafa sağlam study chair
University of Gaziantep
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leone slide low friction elastomeric ligature, RMO tough - o energy elastomeric ligature and Dentsply sili tie elastomeric ligature in people with Orthodontics, run by University of Gaziantep at 1 site in Turkey (Türkiye).
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 3 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 16 Jul 2020. 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 Turkey (Türkiye). 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?
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?
Microbial colonisation change of S mutans (time frame: up to 18 weeks). The study lists 2 primary outcomes in all. 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 16 Jul 2020.