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

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

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

Study Overview

• Status: Unknown
• Conditions: White Spot Lesions
• Intervention / Treatment: Other: ginger and rosemary gel

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 35 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	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.
EXPERIMENTAL: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2019
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): June 1, 2020

Study Registration Dates

• First Submitted: June 13, 2019
• First Submitted That Met QC Criteria: June 18, 2019
• First Posted (ACTUAL): June 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 26, 2019
• Last Update Submitted That Met QC Criteria: June 24, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: OPER - 607

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No