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

Not Applicable

• Conditions: Prevention of Dental Caries
• Interventions: Other: Zinc based toothpaste (Crest complete); Other: dual Zinc plus Arginine based toothpaste (Colgate total); Other: Fluoride based toothpaste (Signal)

• Registration Number: NCT04032210
• Lead Sponsor: Cairo University

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-07-23
• Study First Submitted QC: 2019-07-23
• Last Update Submitted: 2019-07-24
• Study First Posted: 2019-07-25
• Last Update Posted: 2019-07-26
• Study Start: 2019-10-01
• Primary Completion: 2020-10-01
• Study Completion: 2020-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regimen using Zinc based toothpaste (Crest complete)	Zinc based toothpaste (Crest complete)	-
Regimen using dual Zinc plus Arginine based toothpaste	dual Zinc plus Arginine based toothpaste (Colgate total)	-
Fluoride based toothpaste (Signal)	Fluoride based toothpaste (Signal)	-

Primary Outcome Measures

Name	Time	Method
caries risk assessment	Three months	will be evaluated by cariogram

Secondary Outcome Measures

Name	Time	Method
DMF score	12 months	will be evaluated by ICDAS

Trial Locations

Locations (1)

Esraa Abdel Ghaffar Ahmed; 🇪🇬 Giza, Other, Egypt