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Status unknownNCT04254835Updated Feb 5, 2020

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

A Phase 4 interventional study of Cervitec F, Ivoclar Vivadent - Schaan Liechtenstein and Fluor Protector, Ivoclar Vivadent - Schaan Liechtenstein in High Caries Risk Patients, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-05.

Sponsored by Cairo University · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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 .

Read the 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)
02

Conditions studied

  • High Caries Risk Patients
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
34 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DrugCervitec F, Ivoclar Vivadent - Schaan Liechtenstein

    Fluoride varnish containing Chlorhexidine and Cetylpyridinium Chloride

  • DrugFluor Protector, Ivoclar Vivadent - Schaan Liechtenstein

    Conventional Fluoride varnish

06

What researchers measure

Primary outcomes

  1. Plaque Retention

    Checked using a disclosing agent by Silness and Löe Dental Plaque index

    Time frame: Patient will be evaluated at 2nd week of the study in the morning before teeth brushing.

  2. Plaque Retention

    Checked using a disclosing agent by Silness and Löe Dental Plaque index

    Time frame: Patient will be evaluated at 4th week of the study in the morning before teeth brushing.

  3. Plaque Retention

    Checked using a disclosing agent by Silness and Löe Dental Plaque index

    Time frame: Patient will be evaluated at 12th week of the study in the morning before teeth brushing.

  4. Plaque Retention

    Checked using a disclosing agent by Silness and Löe Dental Plaque index

    Time frame: Patient will be evaluated at 24th week of the study in the morning before teeth brushing.

Other outcomes

  1. Plaque bacterial count

    Culture media for mutans streptococci (MS) is used to measure (MS) count in collected plaque samples

    Time frame: Patient will be evaluated at 2nd, 4th, 12th and 24th week of the study in the morning before teeth brushing.

07

Study locations

1 of 1 sites recruiting
  • Faculty of dentistry Cairo Universty
    Giza, 00202, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04254835
Lead sponsor
Cairo University
Responsible party
Hadeer Hesham Mohamed (Principle Investigator, Cairo University) — Principal investigator
First posted
Feb 5, 2020
Start date
Feb 1, 2020
Primary completion
Jul 1, 2020 (estimated)
Completion
Aug 1, 2020 (estimated)
Last update
Feb 5, 2020

Study contacts

Hadeer H Mohamed
Contact
hadeer.hesham91@gmail.com
01015779373 ext. 00202

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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