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

• Sponsor: Cairo University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04446390
• Collaborator: (none)
• Enrollment: 32
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 13.9
• Patients Per Site: 16
• Patients Per Site Per Month: 1.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries	Other: Himalaya complete care toothpaste; Other: colgate cavity protection	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Jan 1, 2021
• Anticipated Primary Completion Date: Mar 1, 2022
• Anticipated Study Completion Date: Mar 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Remineralization of initial carious lesions [Outcomes will be evaluated at baseline, after 1 week, after 4 weeks and after 12 weeks.]

   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

1. Caries risk assessment [Outcomes will be evaluated at baseline, after 1 week, after 4 weeks and after 12 weeks.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo University, Faculty of Oral and Dental Medicine	Cairo		Egypt
2	Cairo University	Cairo		Egypt

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yomna Hussin, Master degree studnet, Conservative Dentistry Department, Faculty of Dentistry, Cairo University., Cairo University
• ClinicalTrials.gov Identifier: NCT04446390
• Other Study ID Numbers: Himalaya herbal toothpaste
• First Posted: Jun 24, 2020
• Last Update Posted: Feb 3, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dental Caries; Listerine; Sodium Fluoride

Study Results

No Results Posted as of Feb 3, 2022