Assessment of Inhibition of Biofilm Formation and Plaque Bacterial Count of Fluoride Varnish Containing Chlorhexidine and Cetylpyridinium Chloride Versus Conventional Fluoride Varnish
NCT ID: NCT04254835
Last Updated: 2020-02-05
Study Results
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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UNKNOWN
PHASE4
34 participants
INTERVENTIONAL
2020-02-01
2020-08-01
Brief Summary
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Detailed Description
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* The diagnostic chart will be filled including all data about the patient's medical history, dental history, plaque assessment and plaque bacterial count.
* Scaling and polishing will be carried out for subjects.
clinical steps:
* Control Group: Conventional Fluoride varnish (Fluor Protector, Ivoclar Vivadent - Schaan Liechtenstein) will be applied on dry teeth in a thin layer, allowed to dry for 1 minute, and participants will be instructed to avoid rinsing after application, only spitting. Eating, drinking and brushing should be avoided for 1 hour after varnish application.
* Intervention Group: Varnish containing Fluoride, Chlorhexidine and Cetylpyridinium Chloride (Cervitec F, Ivoclar Vivadent - Schaan Liechtenstein) will be applied on dry teeth in a thin layer, allowed to dry for 1 minute, and participants will be instructed to avoid rinsing after application, only spitting. Eating, drinking and brushing should be avoided for 1 hour after varnish application.
Each participant will be assessed for plaque retention using plaque index and Standardized photography and image analysis to disclosed dental plaque, and plaque bacterial count using culture media sensitive for mutans streptococci (MS) in the following intervals:
* Enrolment Baseline assessment
* First visit (2nd week)
* Second visit (4th week)
* Third visit (12th week)
* Fourth visit (24th week)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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intervention group
Varnish containing Fluoride, Chlorhexidine and Cetylpyridinium Chloride (Cervitec F, Ivoclar Vivadent - Schaan Liechtenstein) will applied to this group once at the beginning of the study.Plaque and bacterial count will be evaluated at intervals 2 weeks,4 weeks,12 weeks, and 24 weeks.
Cervitec F, Ivoclar Vivadent - Schaan Liechtenstein
Fluoride varnish containing Chlorhexidine and Cetylpyridinium Chloride
control group
Varnish containing Fluoride (Fluor Protector, Ivoclar Vivadent - Schaan Liechtenstein). will applied to this group once at the beginning of the study.
Plaque and bacterial count will be evaluated at intervals 2 weeks,4 weeks,12 weeks, and 24 weeks.
Fluor Protector, Ivoclar Vivadent - Schaan Liechtenstein
Conventional Fluoride varnish
Interventions
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Cervitec F, Ivoclar Vivadent - Schaan Liechtenstein
Fluoride varnish containing Chlorhexidine and Cetylpyridinium Chloride
Fluor Protector, Ivoclar Vivadent - Schaan Liechtenstein
Conventional Fluoride varnish
Eligibility Criteria
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Inclusion Criteria
* No signs of periodontitis.
* Patients had a recorded high bacterial count after caries risk assessment.
* No antibiotic treatment within 1 month prior to the start of the trial.
* No current medication with anti-inflammatory drugs.
* No use of antiseptic mouth rinses.
* Non-smokers.
Exclusion Criteria
* Patients with severe or active periodontal disease.
* Antibiotic treatment within 1 month prior to the start of the trial.
* Current medication with anti-inflammatory drugs.
18 Years
40 Years
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Hadeer Hesham Mohamed
Principle Investigator
Locations
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Faculty of dentistry Cairo Universty
Giza, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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221091
Identifier Type: -
Identifier Source: org_study_id
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