Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
Study NCT ID:
NCT04254835
Status:
UNKNOWN
Last Update Posted:
2020-02-05
First Post:
2019-07-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Inhibition of Biofilm Formation and Plaque Bacterial Count of Fluoride Varnish Containing Chlorhexidine and Cetylpyridinium Chloride Versus Conventional Fluoride Varnish
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
Assessment of Inhibition of Biofilm Formation and Plaque Bacterial Count of Fluoride Varnish Containing Chlorhexidine and Cetylpyridinium Chloride Versus Conventional Fluoride Varnish Among High Caries Risk Patients: Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2020-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Two different Fluoride varnish systems(Fluoride varnish containing Chlorhexidine and Cetylpyridinium Chloride (CPC) and conventional fluoride) will be applied to high caries risk patients to assess their clinical effects on plaque accumulation and plaque bacterial count .
Detailed Description:
Preoperative steps:
* 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)
* 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)
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: