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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04032184

Enrollment

Registered

2019-07-25

Start date

2019-10-01

Completion date

2020-11-01

Last updated

2019-07-25

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

Conditions

Prevention of Dental Caries

Brief 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

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 50 Years

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

* 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

Design outcomes

Primary

Measure	Time frame	Description
Caries Risk Assessment	an average 3 months	will be evaluated by cariogram

Secondary

Measure	Time frame	Description
DMF scores	an average of 12 months	will be evaluated by ICDAS

Countries

Egypt

Contacts

Primary Contacthowaida f fouad, Phd

howaidafakhry@gmail.com00201010008948

Backup ContactEsraa A Ahmed, Phd

ososdent@hotmail.com00201020614170

Outcome results

None listed

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