The Influence of Preventive Regimens Containing Different Toothpastes on Caries Risk of High Risk Patients: A Randomized Clinical Trial
1 other identifier
interventional
66
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2019
CompletedFirst Posted
Study publicly available on registry
July 25, 2019
CompletedStudy Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedJuly 26, 2019
July 1, 2019
1 year
July 23, 2019
July 24, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
caries risk assessment
will be evaluated by cariogram
Three months
Secondary Outcomes (1)
DMF score
12 months
Study Arms (3)
Regimen using dual Zinc plus Arginine based toothpaste
EXPERIMENTALRegimen using Zinc based toothpaste (Crest complete)
EXPERIMENTALFluoride based toothpaste (Signal)
ACTIVE COMPARATORInterventions
Regimen using dual Zinc plus Arginine based toothpaste (Colgate total)
Regimen using Zinc based toothpaste (Crest complete)
Fluoride based toothpaste (Signal)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Esraa Abdel Ghaffar Ahmed
Giza, Other, 8655, Egypt
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- resident of conservative department of faculty of oral and dental medicine
Study Record Dates
First Submitted
July 23, 2019
First Posted
July 25, 2019
Study Start
October 1, 2019
Primary Completion
October 1, 2020
Study Completion
November 1, 2020
Last Updated
July 26, 2019
Record last verified: 2019-07