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

Prevention of Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04032210
• Other study ID #: 2230
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: November 1, 2020

Study information

• Verified date: July 2019
• Source: Cairo University
• Contact: esraa A ahmed, phD
• Phone: 00201020614170
• Email: ososdent[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: November 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Prevention of Dental Caries

Intervention

Other:
• dual Zinc plus Arginine based toothpaste (Colgate total)
Regimen using dual Zinc plus Arginine based toothpaste (Colgate total)
• Zinc based toothpaste (Crest complete)
Regimen using Zinc based toothpaste (Crest complete)
• Fluoride based toothpaste (Signal)
Fluoride based toothpaste (Signal)

Locations

Country	Name	City	State
Egypt	Esraa Abdel Ghaffar Ahmed	Giza	Other

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	caries risk assessment	will be evaluated by cariogram	Three months
Secondary	DMF score	will be evaluated by ICDAS	12 months