Clinical trial NCT04254835: Assessment of Inhibition of Biofilm Formation and Plaque Bacterial Count of Fluoride Varnish Containing Chlorhexidine and Cetylpyridinium Chloride Versus Conventional Fluoride Varnish
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: High Caries Risk Patients
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Plaque Retention
timeFrame: Patient will be evaluated at 2nd week of the study in the morning before teeth brushing.
measure: Plaque Retention
timeFrame: Patient will be evaluated at 4th week of the study in the morning before teeth brushing.
measure: Plaque Retention
timeFrame: Patient will be evaluated at 12th week of the study in the morning before teeth brushing.
measure: Plaque Retention
timeFrame: Patient will be evaluated at 24th week of the study in the morning before teeth brushing.
Secondary outcomes:
Other outcomes:
measure: Plaque bacterial count
timeFrame: Patient will be evaluated at 2nd, 4th, 12th and 24th week of the study in the morning before teeth brushing.
Locations:
city: Giza
country: Egypt
facility: Faculty of dentistry Cairo Universty
Study officials:
References: