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The Influence of Preventive Regimens Containing Different Toothpastes on Caries Risk of High Risk Patients: A Randomized Clinical Trial

The Influence of Preventive Regimens Containing Different Toothpastes on Caries Risk of High Risk Patients: A Randomized Clinical Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04032210
Enrollment
66
Registered
2019-07-25
Start date
2019-10-01
Completion date
2020-11-01
Last updated
2019-07-26

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 will be exposed to regimen including dual zinc plus arginine based toothpaste (Colgate total), (A2) represents participants will be exposed to regimen including zinc based toothpaste (Crest complete) and (A3) represents control group where participants will be used fluoride based toothpaste (Signal). 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: T3) . In addition assessment of DMF scores will be done in four visits: first visit (baseline: T0), second visit (after 3 months: T3), third visit (after 6 months: T6) and final visit (after 12 months: T12) to obtain the required data

Interventions

OTHERdual Zinc plus Arginine based toothpaste (Colgate total)

Regimen using dual Zinc plus Arginine based toothpaste (Colgate total)

OTHERZinc based toothpaste (Crest complete)

Regimen using Zinc based toothpaste (Crest complete)

OTHERFluoride based toothpaste (Signal)

Fluoride based toothpaste (Signal)

Sponsors

Cairo University
Lead SponsorOTHER

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

* • Normal adults will be recruited in this study, all the volunteers participated in this experiment will be healthy looking with free medical history. * Subjects of mean age 20-50 years. * Patients with high caries risk assessment according to Cariogram. * Non cariogenic diet patient * High plaque index * Not under antibiotic therapy either at the time of the study or up to the last month before the start of the study.

Exclusion criteria

* • Patients with a compromised medical history. * Cariogenic diet patient. * Participants with severe or active periodontal disease. * 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

MeasureTime frameDescription
caries risk assessmentThree monthswill be evaluated by cariogram

Secondary

MeasureTime frameDescription
DMF score12 monthswill be evaluated by ICDAS

Countries

Egypt

Contacts

Primary Contactesraa A ahmed, phD
ososdent@hotmail.com00201020614170
Backup Contacthowaida f foad, phD
howaidafakhry@gmail.com00201010008948

Outcome results

None listed

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