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Trial record 16 of 292 for:    Sodium Fluoride OR Duraphat

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

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ClinicalTrials.gov Identifier: NCT03990935
Recruitment Status : Not yet recruiting
First Posted : June 19, 2019
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
Nada Hamada Ahmed Shehab Eldin, Cairo University

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

Condition or disease Intervention/treatment Phase
White Spot Lesions Other: ginger and rosemary gel Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Remineralization Potential of Ginger and Rosemary Herbals Versus Sodium Fluoride in Treatment of White Spot Lesions: "A Randomized Controlled Trial"
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes

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.




Primary Outcome Measures :
  1. (white spot lesion progression) [ Time Frame: T0 Baseline T1 1 months T2 3 months T3 6 months ]
    The change in the lesion fluorescence will be evaluated using diode laser fluorescence device (Diagnodent).



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Ages Eligible for Study:   13 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03990935


Contacts
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Contact: manaa 00201022484815 sara.mohamed.manaa@hotmail.com
Contact: manaa 00201024710307

Locations
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Egypt
Cairo University Recruiting
Cairo, Egypt
Contact: sara manaa         
Sponsors and Collaborators
Cairo University

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Responsible Party: Nada Hamada Ahmed Shehab Eldin, resident at operative dentistry department,cairo university, Cairo University
ClinicalTrials.gov Identifier: NCT03990935     History of Changes
Other Study ID Numbers: OPER - 607
First Posted: June 19, 2019    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Listerine
Fluorides
Sodium Fluoride
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents