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

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

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 .

Study Overview

• Status: Unknown
• Conditions: High Caries Risk Patients
• Intervention / Treatment: Drug: Cervitec F, Ivoclar Vivadent - Schaan Liechtenstein; Drug: Fluor Protector, Ivoclar Vivadent - Schaan Liechtenstein

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)

• Study Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Hadeer H Mohamed; Phone Number: 00202 01015779373; Email: hadeer.hesham91@gmail.com

Study Locations

• Egypt
  • Giza, Egypt, 00202
    • Recruiting
    • Faculty of dentistry Cairo Universty
    • Contact: Amir I Hafez, Associate Professor; Phone Number: 00202 +201100001278; Email: amir.hafez@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Cervitec F, Ivoclar Vivadent - Schaan Liechtenstein; Fluoride varnish containing Chlorhexidine and Cetylpyridinium Chloride
Active Comparator: 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.	Drug: Fluor Protector, Ivoclar Vivadent - Schaan Liechtenstein; Conventional Fluoride varnish

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: July 15, 2019
• First Submitted That Met QC Criteria: February 2, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 2, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents, Local; Anti-Infective Agents; Chlorhexidine, thymol drug combination
• Other Study ID Numbers: 221091

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No