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

Phase 4

• Conditions: High Caries Risk Patients
• Interventions: Drug: Fluor Protector, Ivoclar Vivadent - Schaan Liechtenstein; Drug: Cervitec F, Ivoclar Vivadent - Schaan Liechtenstein

• Registration Number: NCT04254835
• Lead Sponsor: Cairo University

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)

Study Timeline

• Study First Submitted: 2019-07-15
• Status Verified: 2020-02
• Study Start: 2020-02-01
• Study First Submitted QC: 2020-02-02
• Last Update Submitted: 2020-02-02
• Study First Posted: 2020-02-05
• Last Update Posted: 2020-02-05
• Primary Completion: 2020-07-01
• Study Completion: 2020-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Fluor Protector, Ivoclar Vivadent - Schaan Liechtenstein	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.
intervention group	Cervitec F, Ivoclar Vivadent - Schaan Liechtenstein	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.

Primary Outcome Measures

Name	Time	Method
Plaque Retention	Patient will be evaluated at 24th week of the study in the morning before teeth brushing.	Checked using a disclosing agent by Silness and Löe Dental Plaque index

Trial Locations

Locations (1)

Faculty of dentistry Cairo Universty; 🇪🇬 Giza, Egypt