Back to resultsEffect of Chlorhexidine Gel on Bacterial Count During Fixed Orthodontic Treatment
Primary Purpose
Orthodontic Appliance Complication, Dental Caries
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Chlorhexidine gluconate
Sponsored by
About this trial
This is an interventional prevention trial for Orthodontic Appliance Complication focused on measuring chlorhexidine gel, orthodontic brackets, orthodontic patients, bacterial count, friction
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
chlorhexidine gel
Arm Description
anti microbial agent that prevents the formation of plaque and reduces caries risk
Outcomes
Primary Outcome Measures
mutants streptococcus count
measures the change in bacterial count before and after application of the gel
Secondary Outcome Measures
friction
measures static and dynamic friction in Newton
Full Information
NCT ID
NCT02001311
First Posted
November 20, 2013
Last Updated
November 27, 2013
Sponsor
King Abdulaziz University
1. Study Identification
Unique Protocol Identification Number
NCT02001311
Brief Title
Effect of Chlorhexidine Gel on Bacterial Count During Fixed Orthodontic Treatment
Official Title
Effect of Chlorhexidine Gel on Bacterial Count and Orthodontic Brackets During Fixed Orthodontic Treatment; In-vivo & In-vitro Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
April 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Abdulaziz University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthodontic Appliance Complication, Dental Caries
Keywords
chlorhexidine gel, orthodontic brackets, orthodontic patients, bacterial count, friction
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
chlorhexidine gel
Arm Type
Experimental
Arm Description
anti microbial agent that prevents the formation of plaque and reduces caries risk
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine gluconate
Primary Outcome Measure Information:
Title
mutants streptococcus count
Description
measures the change in bacterial count before and after application of the gel
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
friction
Description
measures static and dynamic friction in Newton
Time Frame
2 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mona A Abbassy
Phone
0096658349507
Email
monaabbassy@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed S Bakry
Phone
00966593944171
Email
drahmedbakry@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samar M Al-Bazi
Organizational Affiliation
King Abdulaziz University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
27021538
Citation
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.
Results Reference
derived
Learn more about this trial
Effect of Chlorhexidine Gel on Bacterial Count During Fixed Orthodontic Treatment
We'll reach out to this number within 24 hrs