Effect of Chlorhexidine Gel on Bacterial Count During Fix... | NCT02001311

Studies
Effect of Chlorhexidine Gel on Bacterial Count During Fixed Orthodontic Treatment

NCT02001311

Sponsor

King Abdulaziz University

Status

Unknown status

Last Update Posted

Dec 4, 2013Estimated

Enrollment

20Estimated

Phase

Phase 1

Conditions

Orthodontic Appliance Complication
Dental Caries

Interventions

Chlorhexidine gluconate

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Apr 2014Estimated

Completion Date

Jun 2014Estimated

First Submitted Date

Nov 20, 2013

First Submission Date that Met QC Criteria

Nov 27, 2013

First Posted Date

Dec 4, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 27, 2013

Last Update Posted Date

Dec 4, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
chlorhexidine gel	Experimental	anti microbial agent that prevents the formation of plaque and reduces caries risk	Drug: Chlorhexidine gluconate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chlorhexidine gluconate	Drug		chlorhexidine gel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mutants streptococcus count	measures the change in bacterial count before and after application of the gel	48 hours

Secondary Outcomes

Measure	Description	Time Frame
friction	measures static and dynamic friction in Newton	2 minutes

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mona A Abbassy	Contact	0096658349507		monaabbassy@gmail.com
Ahmed S Bakry	Contact	00966593944171		drahmedbakry@gmail.com

Overall Officials

Name	Affiliation	Role
Samar M Al-Bazi	King Abdulaziz University	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27021538	Derived	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.

ID	Term
D017001	Tooth Demineralization
D014076	Tooth Diseases
D009057	Stomatognathic Diseases