Assessment of Inhibition of Biofilm Formation and Plaque Bacterial Count of Fluoride Varnish Containing Chlorhexidine and Cetylpyridinium Chloride Versus Conventional Fluoride Varnish

High Caries Risk Patients Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04254835
• Other study ID #: 221091
• Status: Recruiting
• Phase: Phase 4
• Start date: February 1, 2020
• Est. completion date: August 1, 2020

Study information

• Verified date: February 2020
• Source: Cairo University
• Contact: Hadeer H Mohamed
• Phone: 01015779373
• Email: hadeer.hesham91[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: August 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

Patients with good general state of health.

• 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 disabilities, systemic disease or severe medical conditions.

• 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.

Related Conditions & MeSH terms

• High Caries Risk Patients

Intervention

Drug:
• Cervitec F, Ivoclar Vivadent - Schaan Liechtenstein
Fluoride varnish containing Chlorhexidine and Cetylpyridinium Chloride
• Fluor Protector, Ivoclar Vivadent - Schaan Liechtenstein
Conventional Fluoride varnish

Locations

Country	Name	City	State
Egypt	Faculty of dentistry Cairo Universty	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plaque bacterial count	Culture media for mutans streptococci (MS) is used to measure (MS) count in collected plaque samples	Patient will be evaluated at 2nd, 4th, 12th and 24th week of the study in the morning before teeth brushing.
Primary	Plaque Retention	Checked using a disclosing agent by Silness and Löe Dental Plaque index	Patient will be evaluated at 2nd week of the study in the morning before teeth brushing.
Primary	Plaque Retention	Checked using a disclosing agent by Silness and Löe Dental Plaque index	Patient will be evaluated at 4th week of the study in the morning before teeth brushing.
Primary	Plaque Retention	Checked using a disclosing agent by Silness and Löe Dental Plaque index	Patient will be evaluated at 12th week of the study in the morning before teeth brushing.
Primary	Plaque Retention	Checked using a disclosing agent by Silness and Löe Dental Plaque index	Patient will be evaluated at 24th week of the study in the morning before teeth brushing.