Remineralization Potential of Ginger and Rosemary Herbals Versus Sodium Fluoride in Treatment of White Spot Lesions

White Spot Lesions Clinical Trial

Official title:

Remineralization Potential of Ginger and Rosemary Herbals Versus Sodium Fluoride in Treatment of White Spot Lesions: "A Randomized Controlled Trial"

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03990935
• Other study ID #: OPER - 607
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2019
• Est. completion date: June 2020

Study information

• Verified date: June 2019
• Source: Cairo University
• Contact: manaa
• Phone: 00201022484815
• Email: sara.mohamed.manaa[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the effectiveness of ginger and rosemary herbals versus sodium fluoride in remineralization of incipient enamel caries.

Description:

Group 1 (intervention)

Ginger and rosemary gel application:

First the participant will be asked to brush his/her teeth thoroughly with 1450 ppm fluoride toothpaste (Colgate total healthy clean toothpaste). Then an application of a thin ribbon of this gel to the teeth using a brush. The medication will be left for at least 1 minute. The participant will be asked to spit out the medication after use and not to swallow it. Also the participant will be asked not to rinse his/her mouth, eat, or drink for at least 30 minutes after use to get the best results.

Group 2 (control group). Sodium fluoride varnish The fluoride varnish will be bifluorid 10 single use by voco (Germany). It Contains 5 % sodium fluoride (equal to 22,600 ppm fluoride).

A thin coat will be applied on the tooth surface by using a brush. 10-20 s are sufficient for the varnish to be absorbed and then dry with air. Participants will be informed that they should not brush their teeth for 12-24 hours after the application and not to eat, or drink for at least 30 minutes after use to get the best results.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 35 Years

Eligibility

Inclusion Criteria:

• Patient who has just completed a comprehensive orthodontic treatment.

• Presence of at least one WSL, DIAGNOdent score (0-20).

• Age range between 13 and 35years.

Exclusion Criteria:

• Patients with a compromised medical history.

• Severe or active periodontal disease

• Patients with developmental hypo-calcified lesions

Related Conditions & MeSH terms

• Dental Caries
• White Spot Lesions

Intervention

Other:
• ginger and rosemary gel
First the participant will be asked to brush his/her teeth thoroughly with 1450 ppm fluoride toothpaste (Colgate total healthy clean toothpaste). Then an application of a thin ribbon of this gel to the teeth using a brush. The medication will be left for at least 1 minute. The participant will be asked to spit out the medication after use and not to swallow it. Also the participant will be asked not to rinse his/her mouth, eat, or drink for at least 30 minutes after use to get the best results.

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(white spot lesion progression)	The change in the lesion fluorescence will be evaluated using diode laser fluorescence device (Diagnodent).	T0 Baseline T1 1 months T2 3 months T3 6 months