Effect of Chlorhexidine Gel on Bacterial Count During Fixed Orthodontic Treatment
1 other identifier
interventional
20
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2014
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2013
CompletedFirst Posted
Study publicly available on registry
December 4, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedDecember 4, 2013
November 1, 2013
3 months
November 20, 2013
November 27, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
mutants streptococcus count
measures the change in bacterial count before and after application of the gel
48 hours
Secondary Outcomes (1)
friction
2 minutes
Study Arms (1)
chlorhexidine gel
EXPERIMENTALanti microbial agent that prevents the formation of plaque and reduces caries risk
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 27021538DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Samar M Al-Bazi
King Abdulaziz University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
November 20, 2013
First Posted
December 4, 2013
Study Start
January 1, 2014
Primary Completion
April 1, 2014
Study Completion
June 1, 2014
Last Updated
December 4, 2013
Record last verified: 2013-11