Orthodontic Appliance ComplicationPhase 1NCT02001311
Effect of Chlorhexidine Gel on Bacterial Count During Fixed Orthodontic Treatment
A Phase 1 study testing Chlorhexidine gluconate in people with Orthodontic Appliance Complication and Dental Caries, run by King Abdulaziz University.
Trial summary
This study investigates the benefit of using chlorhexidine gel as an antimicrobial agent in orthodontic patient to reduce caries risk and the possible consequential effect of this use on the orthodontic brackets used for the treatment. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliance Complication, Dental Caries
- What is being tested?
- Chlorhexidine gluconate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jun 2014
- Phase
- Phase 1
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients' age range from 18-30 years.
- Fixed orthodontic treatment.
- All the patients are at the end of leveling and alignment stage.
- Initial bacterial count indicates high caries risk.
- All patients will be given good oral hygiene instruction at the first visit.
- The subjects had not taken antibiotics for at least 6 weeks before saliva sampling or during the experimental period.
- All subjects used a fluoride dentifrice twice a day.
Who cannot join
- Patients' age more or less then the age range specified.
- Removable orthodontic treatment.
- Patients at early stages of leveling and alignment.
- Initial bacterial count indicates low caries risk.
- Subjects that have taken antibiotics for at least 6 weeks before saliva sampling.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Chlorhexidine Gel on Bacterial Count and Orthodontic Brackets During Fixed Orthodontic Treatment; In-vivo & In-vitro Study
This study investigates the benefit of using chlorhexidine gel as an antimicrobial agent in orthodontic patient to reduce caries risk and the possible consequential effect of this use on the orthodontic brackets used for the treatment.
The investigators hypothesis is that chlorhexidine gel use can reduce caries risk in orthodontic patients with out causing damage to the bonded ceramic or metal orthodontic brackets.
- Conditions
- Orthodontic Appliance Complication, Dental Caries
- Being tested
- Chlorhexidine gluconate
- Keywords
- chlorhexidine gel, orthodontic brackets, orthodontic patients, bacterial count, friction
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine gluconateDrug
| Study group | Role | What they receive |
|---|---|---|
| chlorhexidine gel | Experimental | anti microbial agent that prevents the formation of plaque and reduces caries risk Receives: Drug: Chlorhexidine gluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
mutants streptococcus count
measures the change in bacterial count before and after application of the gel
Measured: 48 hours
Secondary outcomes (1)
friction
measures static and dynamic friction in Newton
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionApr 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthodontic Appliance ComplicationStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Samar Al-Bazi, King Abdulaziz University
- Investigators
- Samar M Al-Bazi, Principal investigator, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001311
- Sponsor's protocol ID
- 123
- Status last verified
- Nov 2013
- First submitted
- 20 Nov 2013
- Last updated
- 4 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Al-Bazi SM, Abbassy MA, Bakry AS, Merdad LA, Hassan AH. Effects of chlorhexidine (gel) application on bacterial levels and orthodontic brackets during orthodontic treatment. J Oral Sci. 2016;58(1):35-42. doi: 10.2334/josnusd.58.35.
PubMed 27021538
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chlorhexidine Gel on Bacterial Count and Orthodontic Brackets During Fixed Orthodontic Treatment; In-vivo & In-vitro Study
- ClinicalTrials.gov ID
- NCT02001311
- Acronym / sponsor ID
- 123
- Conditions
- Orthodontic Appliance Complication, Dental Caries
- Keywords
- chlorhexidine gel, orthodontic brackets, orthodontic patients, bacterial count, friction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 4 Dec 2013 (estimated)
- 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 investigates the benefit of using chlorhexidine gel as an antimicrobial agent in orthodontic patient to reduce caries risk and the possible consequential effect of this use on the orthodontic brackets used for the treatment.
The investigators hypothesis is that chlorhexidine gel use can reduce caries risk in orthodontic patients with out causing damage to the bonded ceramic or metal orthodontic brackets.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chlorhexidine gel | Experimental | Drug: Chlorhexidine gluconateanti microbial agent that prevents the formation of plaque and reduces caries risk |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients' age range from 18-30 years.
- Fixed orthodontic treatment.
- All the patients are at the end of leveling and alignment stage.
- Initial bacterial count indicates high caries risk.
- All patients will be given good oral hygiene instruction at the first visit.
Key exclusion criteria (5 listed)
- Patients' age more or less then the age range specified.
- Removable orthodontic treatment.
- Patients at early stages of leveling and alignment.
- Initial bacterial count indicates low caries risk.
- Subjects that have taken antibiotics for at least 6 weeks before saliva sampling.
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 |
|---|---|---|
| Chlorhexidine gluconate | Drug | chlorhexidine gel |
Primary outcome
mutants streptococcus count
Time frame: 48 hours
measures the change in bacterial count before and after application of the gel
1 secondary outcome
friction
Time frame: 2 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.
- Derived from this study: PubMed 27021538Al-Bazi SM, Abbassy MA, Bakry AS, Merdad LA, Hassan AH. Effects of chlorhexidine (gel) application on bacterial levels and orthodontic brackets during orthodontic treatment. J Oral Sci. 2016;58(1):35-42. doi: 10.2334/josnusd.58.35.
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The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation in Orthodontics Pain
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Microbial Adherence, Surface Roughness, Effectiveness and Impact on Patients Between Conventional and 3D Printed Twin Block Appliances
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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.
Samar M Al-Bazi principal investigator
King Abdulaziz University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Chlorhexidine gluconate in people with Orthodontic Appliance Complication and Dental Caries, run by King Abdulaziz 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 7 inclusion and 5 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 4 Dec 2013. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Mona A Abbassy (0096658349507, monaabbassy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mutants streptococcus count (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02001311, which also lists 1 linked publication.
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 4 Dec 2013.