Skip to content

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04254835
Enrollment
34
Registered
2020-02-05
Start date
2020-02-01
Completion date
2020-08-01
Last updated
2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Caries Risk Patients

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)

Interventions

DRUGCervitec F, Ivoclar Vivadent - Schaan Liechtenstein

Fluoride varnish containing Chlorhexidine and Cetylpyridinium Chloride

DRUGFluor Protector, Ivoclar Vivadent - Schaan Liechtenstein

Conventional Fluoride varnish

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Plaque RetentionPatient will be evaluated at 2nd week of the study in the morning before teeth brushing.Checked using a disclosing agent by Silness and Löe Dental Plaque index

Other

MeasureTime frameDescription
Plaque bacterial countPatient will be evaluated at 2nd, 4th, 12th and 24th week of the study in the morning before teeth brushing.Culture media for mutans streptococci (MS) is used to measure (MS) count in collected plaque samples

Countries

Egypt

Contacts

Primary ContactHadeer H Mohamed
hadeer.hesham91@gmail.com01015779373

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026