Effect of Chlorhexidine Gel on Bacterial Count During Fixed Orthodontic Treatment

NCT ID: NCT02001311

Last Updated: 2013-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-06-30

Brief Summary

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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

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Conditions

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Orthodontic Appliance Complication Dental Caries

Keywords

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chlorhexidine gel orthodontic brackets orthodontic patients bacterial count friction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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chlorhexidine gel

anti microbial agent that prevents the formation of plaque and reduces caries risk

Group Type EXPERIMENTAL

Chlorhexidine gluconate

Intervention Type DRUG

Interventions

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Chlorhexidine gluconate

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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King Abdulaziz University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Samar Al-Bazi

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Samar M Al-Bazi

Role: PRINCIPAL_INVESTIGATOR

King Abdulaziz University

Central Contacts

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Mona A Abbassy

Role: CONTACT

Phone: 0096658349507

Email: [email protected]

Ahmed S Bakry

Role: CONTACT

Phone: 00966593944171

Email: [email protected]

References

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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.

Reference Type DERIVED
PMID: 27021538 (View on PubMed)

Other Identifiers

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123

Identifier Type: -

Identifier Source: org_study_id