Preventive Regimens With Herbal and Fluoride Toothpaste on Remineralization in High Caries Patients With Initial Lesions

Evaluation of Remineralization Potential of Preventive Regimens Containing Herbal-based Compared to Fluoride-based Toothpastes in High Caries Risk Patients With Initial Carious Lesions: Randomized Clinical Trial

This study will be conducted to assess the effect of different preventive regimens using herbal toothpaste versus fluoride toothpaste on the management of remineralization and caries risk in high caries risk patients.

Study Overview

• Status: Active, not recruiting
• Conditions: Dental Caries
• Intervention / Treatment: Other: Himalaya complete care toothpaste; Other: colgate cavity protection

Detailed Description

Dental caries is a major universal health problem with multiple etiological factors, so looking for economical and accurate plans for recognizing high-risk persons, and multiple risk factors to reduce the risk, in addition to caries management, using a caries risk assessment to detect the person who will develop caries, and provide them with suitable preventive and treatment regimens to disruption the disease procedure.

The treatment should evade invasive treatments and a large emphasis on prevention (using fluoride toothpaste, solutions, patient education, and so on), to achieve the aim of new dentistry (minimal intervention). The application of such a regimen to manage initial caries lesions allows the dentist to reverse initial lesions with the minimal victim of healthy dental tissues.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University
  • Cairo, Egypt
    • Cairo university, Faculty of oral and dental medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• Inclusion criteria of the participants:

  1. Healthy patients with free medical history.
  2. Age range 15-50 years.
  3. Patients with high caries risk assessment according to Cariogram.
  4. Patients with initial carious lesions at the facial surface of any teeth
  5. High plaque index
  6. 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 of the participants:

  1. Patients with a compromised medical history.
  2. Patients with dentin caries
  3. Extreme plaque accumulation and periodontal problems
  4. Completely edentulous patients
  5. Participants with a history of allergy to any of the drugs or chemicals used in the study.
  6. Patients on any antibiotics during the past month

• Inclusion criteria of the teeth:

  1. The WSLs with LF measurements inside the range 14-20 were involved in this study.
  2. The lesions with scoring either 2 or 3 according to (ICDAS) scoring were included in the study

• Exclusion criteria of the teeth:

  1. The white spot lesion scoring is (<14) or (>20) according to diagnodent
  2. The white spot lesion scoring is other than 2, 3 according to ICDAS
  3. White spot lesions due to hypomineralization or fluorosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: preventive regimen using Herbal toothpaste(Himalaya); The regimen includes herbal toothpaste containing "Neem , Miswak , Babool and Pomegranate" (Himalaya Complete Care). Chew xylitol gum 2 pieces four times per day for 5 minutes after meals.	Other: Himalaya complete care toothpaste; Herbal toothpaste as a part of a caries preventive regimen
Active Comparator: preventive regimen using Fluoride based toothpaste(colgate); preventive regimen using Fluoride based toothpaste (colgate cavity protection). Participants will be using a fluoride-based toothpaste (colgate cavity protection), (1450 ppm Sodium monofluorophosphate). chew xylitol gum 2 pieces four times per day for 5 minutes after meals.	Other: colgate cavity protection; fluoride toothpaste as a part of a caries preventive regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remineralization of initial carious lesions	changes in fluorescence of white spot lesions will be evaluated after reminerlization by using Diagnodent scoring (0-20): healthy teeth (0-14), initial carious lesions (14-20), dentinal caries (more than 20)	Outcomes will be evaluated at baseline, after 1 week, after 4 weeks and after 12 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caries risk assessment	Change in caries risk assessment by "cariogram software" as each patient data is collected in order to be inserted into the "Cariogram software" which in turn will evaluate this data and lead to a pie chart showing the chance of avoiding new caries as percentage.	Outcomes will be evaluated at baseline, after 1 week, after 4 weeks and after 12 weeks.

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: June 22, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (Actual): June 24, 2020

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: January 20, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Listerine; Sodium Fluoride
• Other Study ID Numbers: Himalaya herbal toothpaste

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No