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

NCT ID: NCT03990935

Last Updated: 2019-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-31

Study Completion Date

2020-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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White Spot Lesions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

ginger and rosemary gel

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

ginger and rosemary gel

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Nada Hamada Ahmed Shehab Eldin

resident at operative dentistry department,cairo university

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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manaa

Role: CONTACT

00201022484815

manaa

Role: CONTACT

00201024710307

Facility Contacts

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sara manaa

Role: primary

Other Identifiers

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OPER - 607

Identifier Type: -

Identifier Source: org_study_id

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