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

NCT ID: NCT04446390

Last Updated: 2022-02-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2022-03-01

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.

Conditions

Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Himalaya complete care toothpaste

Intervention Type: OTHER

Herbal toothpaste as a part of a caries preventive regimen

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.

Group Type: ACTIVE_COMPARATOR

colgate cavity protection

Intervention Type: OTHER

fluoride toothpaste as a part of a caries preventive regimen

Interventions

Himalaya complete care toothpaste

Herbal toothpaste as a part of a caries preventive regimen

Intervention Type: OTHER

colgate cavity protection

fluoride toothpaste as a part of a caries preventive regimen

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

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

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

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Yomna Hussin

Master degree studnet, Conservative Dentistry Department, Faculty of Dentistry, Cairo University.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University, Faculty of Oral and Dental Medicine

Cairo, , Egypt

Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Himalaya herbal toothpaste

Identifier Type: -

Identifier Source: org_study_id