NCT04254835

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2020

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

5 months

First QC Date

July 15, 2019

Last Update Submit

February 2, 2020

Conditions

High Caries Risk Patients

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

  • Plaque bacterial count

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

Study Arms (2)

intervention group

EXPERIMENTAL

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

control group

ACTIVE COMPARATOR

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

Cervitec F, Ivoclar Vivadent - Schaan LiechtensteinDRUG

Fluoride varnish containing Chlorhexidine and Cetylpyridinium Chloride

intervention group
Fluor Protector, Ivoclar Vivadent - Schaan LiechtensteinDRUG

Conventional Fluoride varnish

control group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry Cairo Universty

Giza, 00202, Egypt

RECRUITING

MeSH Terms

Interventions

Fluor Protector

Central Study Contacts

Hadeer H Mohamed

CONTACT

01015779373hadeer.hesham91@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

July 15, 2019

First Posted

February 5, 2020

Study Start

February 1, 2020

Primary Completion

July 1, 2020

Study Completion

August 1, 2020

Last Updated

February 5, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)