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

Cairo University (CU)

Status: Unknown

Conditions: Prevention of Dental Caries

Treatments: Other: Fluoride based toothpaste (Signal); Other: Zinc based toothpaste (Crest complete); Other: dual Zinc plus Arginine based toothpaste (Colgate total)

Study type: Interventional

Funder types: Other

Identifiers

NCT04032210

2230

Details and patient eligibility

About

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

Enrollment: 66 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

66 participants in 3 patient groups

Regimen using dual Zinc plus Arginine based toothpaste

Experimental group

Treatment:

Other: dual Zinc plus Arginine based toothpaste (Colgate total)

Regimen using Zinc based toothpaste (Crest complete)

Experimental group

Treatment:

Other: Zinc based toothpaste (Crest complete)

Fluoride based toothpaste (Signal)

Active Comparator group

Treatment:

Other: Fluoride based toothpaste (Signal)