CClinicalTrials.gg
Status unknownNCT04032184Updated Jul 25, 2019

Effectiveness of Different Preventive Regimens in Cariogram Parameters and DMF Scores of High Caries Risk Patients: A Randomized Control Trial

An interventional study of Fluoride toothpaste and fluoride toothpaste and chlorhexidine mouthwash in Prevention of Dental Caries, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-25.

Sponsored by Cairo University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study summary

66 Participants will be divided into three groups according to the tested regimen (A), where (A1) represents participants exposed to fluoride toothpaste, (A2) represents participants exposed to regimen including fluoride toothpaste and chlorhexidine mouthwash and (A3) represents participants exposed to regimen including fluoride toothpaste, chlorhexidine mouthwash and MI fluoride varnish. The study will be carried over a period of one year, assessment of cariogram will be done in two visits: first visit (baseline: T0) and second visit (after 3 months: T2). In addition assessment of DMF scores will be done in four visits: first visit (baseline: T0), second visit (after 3 months: T1), third visit (after 6 months: T2) and final visit (after 12 months: T3) to obtain the required data

02

Conditions studied

  • Prevention of Dental Caries

Browse trials for

03

In context

Dental Caries

1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.

This study's planned enrollment of 66 is close to the median of 60 across 916 interventional studies indexed under Dental Caries.

Browse Dental Caries studies →

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
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age range 20-50 years
  • High caries risk patients defined according to cariogram caries risk assessment model
  • On non-cariogenic diet
  • High plaque index
  • Systematically healthy
  • No orthodontic or prosthodontic appliance

Exclusion criteria

Exclusion Criteria:

  • Age range less than 20 or more than 50 years
  • Low or moderate caries risk patients according to cariogram
  • Patients with a compromised medical history
  • Cariogenic diet patient
  • Participants with a history of allergy to any of the drugs or chemicals used in the study
  • Patients on any antibiotics during the past month
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
66 participants (estimated)

Study arms

  • Active comparator
    Fluoride toothpaste

    Other: Fluoride toothpaste

  • Experimental
    fluoride toothpaste and chlorhexidine mouthwash

    Other: fluoride toothpaste and chlorhexidine mouthwash

  • Experimental
    fluoride toothpaste, chlorhexidine mouthwash, MI varnish

    Other: fluoride toothpaste, chlorhexidine mouthwash, MI varnish

Interventions

  • OtherFluoride toothpaste

    regimen using fluoride toothpaste

  • Otherfluoride toothpaste and chlorhexidine mouthwash

    regimen using fluoride toothpaste and chlorhexidine mouthwash

  • Otherfluoride toothpaste, chlorhexidine mouthwash, MI varnish

    regimen using fluoride toothpaste, chlorhexidine mouthwash, MI varnish

06

What researchers measure

Primary outcomes

  1. Caries Risk Assessment

    will be evaluated by cariogram

    Time frame: an average 3 months

Secondary outcomes

  1. DMF scores

    will be evaluated by ICDAS

    Time frame: an average of 12 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

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 Jul 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04032184
Lead sponsor
Cairo University
Responsible party
Howaida Fakhry Fouad (Resident of conservative departement , Faculty of Oral and Dental Medicine, Cairo university 2012, Cairo University) — Principal investigator
First posted
Jul 25, 2019
Start date
Oct 1, 2019 (estimated)
Primary completion
Oct 1, 2020 (estimated)
Completion
Nov 1, 2020 (estimated)
Last update
Jul 25, 2019

Study contacts

howaida f fouad, Phd
Contact
howaidafakhry@gmail.com
00201010008948
Esraa A Ahmed, Phd
Contact
ososdent@hotmail.com
00201020614170

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 Jul 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion