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

Primary Purpose

Dental Caries

Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Himalaya complete care toothpaste
colgate cavity protection
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries

Eligibility Criteria

15 Years - 50 Years (Child, Adult)All SexesAccepts Healthy Volunteers

  • 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

Sites / Locations

  • Cairo University, Faculty of Oral and Dental Medicine
  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

preventive regimen using Herbal toothpaste(Himalaya)

preventive regimen using Fluoride based toothpaste(colgate)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.

Full Information

First Posted
June 22, 2020
Last Updated
January 20, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04446390
Brief Title
Preventive Regimens With Herbal and Fluoride Toothpaste on Remineralization in High Caries Patients With Initial Lesions
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
March 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
preventive regimen using Herbal toothpaste(Himalaya)
Arm Type
Experimental
Arm Description
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.
Arm Title
preventive regimen using Fluoride based toothpaste(colgate)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Himalaya complete care toothpaste
Intervention Description
Herbal toothpaste as a part of a caries preventive regimen
Intervention Type
Other
Intervention Name(s)
colgate cavity protection
Intervention Description
fluoride toothpaste as a part of a caries preventive regimen
Primary Outcome Measure Information:
Title
Remineralization of initial carious lesions
Description
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)
Time Frame
Outcomes will be evaluated at baseline, after 1 week, after 4 weeks and after 12 weeks.
Secondary Outcome Measure Information:
Title
Caries risk assessment
Description
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.
Time Frame
Outcomes will be evaluated at baseline, after 1 week, after 4 weeks and after 12 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria of the participants: Healthy patients with free medical history. Age range 15-50 years. Patients with high caries risk assessment according to Cariogram. Patients with initial carious lesions at the facial surface of any teeth 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 of the participants: Patients with a compromised medical history. Patients with dentin caries Extreme plaque accumulation and periodontal problems Completely edentulous patients 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 Inclusion criteria of the teeth: The WSLs with LF measurements inside the range 14-20 were involved in this study. The lesions with scoring either 2 or 3 according to (ICDAS) scoring were included in the study Exclusion criteria of the teeth: The white spot lesion scoring is (<14) or (>20) according to diagnodent The white spot lesion scoring is other than 2, 3 according to ICDAS White spot lesions due to hypomineralization or fluorosis
Facility Information:
Facility Name
Cairo University, Faculty of Oral and Dental Medicine
City
Cairo
Country
Egypt
Facility Name
Cairo University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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

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