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

Dental Caries Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04446390
• Other study ID #: Himalaya herbal toothpaste
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: January 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 50 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Dental Caries

Intervention

Other:
• Himalaya complete care toothpaste
Herbal toothpaste as a part of a caries preventive regimen
• colgate cavity protection
fluoride toothpaste as a part of a caries preventive regimen

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo
Egypt	Cairo University, Faculty of Oral and Dental Medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.