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

NCT03990935 | Unknown DMC

• 1 other identifier: OPER - 607
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

White Spot Lesions

Outcome Measures

Primary Outcomes (1)

• (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

Study Arms (2)

sodium fluoride varnish

ACTIVE COMPARATOR

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

Ginger and rosemary gel

EXPERIMENTAL

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

Interventions

ginger and rosemary gel 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; sodium fluoride varnish

Eligibility Criteria

• Age: 13 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients with a compromised medical history.
• Severe or active periodontal disease
• Patients with developmental hypo-calcified lesions

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Interventions

ginger extract

Central Study Contacts

manaa

CONTACT

00201022484815; sara.mohamed.manaa@hotmail.com

manaa

CONTACT

00201024710307

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident at operative dentistry department,cairo university

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: June 19, 2019
• Study Start: July 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2020
• Last Updated: June 26, 2019

Record last verified: 2019-06

Locations

EG (1)