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Remineralizing Efficacy of Grape Seed Extract in Management of White Spot Lesion in Post Orthodontic Treated Patients.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04357093
Recruitment Status : Unknown
Verified January 2021 by Nada Abd El Sattar Mohamed Kotb, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : April 22, 2020
Last Update Posted : January 26, 2021
Information provided by (Responsible Party):
Nada Abd El Sattar Mohamed Kotb, Cairo University

Brief Summary:
This clinical trial will be conducted to compare the efficacy of grape seed extract oil versus sodium fluoride mouth wash in the management of remineralization in adult patients with white spot lesion over six months.

Condition or disease Intervention/treatment Phase
Dental Caries Other: Grape seed extract mouthwash Other: Sodium fluoride mouthwash Not Applicable

Detailed Description:

Natural products have long been used in traditional medicine and are promising sources for novel therapeutic agents, especially in treating oral diseases such as dental caries.

Previously, herbs are used in dentistry for prevention and curative purpose of dental caries. The main advantages of using herbal alternatives are easy availability, cost effectiveness, increased shelf life, low toxicity, and lack of microbial resistance.

Grape seed extract (GSE) has been found to be a promising natural remineralizing agent for treatment of the demineralized tooth.

Grape seed extract (GSE), a readily available over the counter supplement, has been noted for its potential dental restorative and caries preventative properties as a potent antioxidant. There are multiple bioactive properties in GSE, but in particular, its rich content of proanthocyanidins (PACs) plays a role in its theoretical benefit in caries prevention.

PACs have hydrophobic and hydrophilic properties, which enhance their ability to irreversibly bind to a variety of compounds, particularly minerals, proteins, and carbohydrates.

The remineralization effect of GSE appears to be featured. First, it participates in mineral deposition on the superficial layer of the lesion through forming insoluble complexes and combines with calcium to enhance remineralization. Second, GSE may interact with the organic portion of enamel through PA-collagen interaction, thereby stabilizing the exposed collagen matrix.

Proanthocyanidin (PA) has been proved to strengthen collagen-based tissues by increasing collagen cross-links. It is claimed that it can increase collagen synthesis and accelerates the conversion of soluble collagen into insoluble collagen. Proanthocyanidin has proved safe in different clinical applications and has been used as dietary supplements as well.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Remineralizing Efficacy of Grape Seed Extract Oil Versus Fluoride Mouthwash in Management of Post-Orthodontic White Spot Lesions: Randomized Clinical Trial
Estimated Study Start Date : February 2021
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes

Arm Intervention/treatment
Experimental: Grape seed extract mouthwash
Grape seed extract mouth wash 15% concentration
Other: Grape seed extract mouthwash
Mouthwash 15% grape seed extract
Other Name: Grape seed extract

Active Comparator: Sodium fluoride mouthwash
Sodium fluoride mouthwash 1000 ppm
Other: Sodium fluoride mouthwash
Sodium fluoride mouthwash

Primary Outcome Measures :
  1. Remineralization of white spot lesions [ Time Frame: Evaluation of tooth surface changes at baseline and at 1, 3 and 6 months after starting treatment . ]
    changes in fluorescence of white spot lesions will be evaluated after reminerlization by using Diagnodent scoring (0-20)

Secondary Outcome Measures :
  1. Satisfaction of the patient: questionnaire [ Time Frame: After 6 months ]
    Using binary questionnaire ( Yes/No)

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Presence of at least two WSLs on the labial surfaces of six maxillary anterior teeth that were not present before orthodontic therapy
  • Age range between 13 and 30years.

Exclusion Criteria:

  • Severe or active periodontal disease.
  • Patients had received therapeutic irradiation to the head and neck region.
  • Patients had participated in a clinical trial within 6 months before commencement of this trial.
  • Patients unable to return for recall appointments
  • Presence of abnormal oral, medical, or mental condition.
  • Presence of dentin caries or enamel hypoplasia on maxillary anterior teeth.
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Responsible Party: Nada Abd El Sattar Mohamed Kotb, Master degree studnet, Conservative Dentistry Department, Faculty of Dentistry, Cairo University., Cairo University Identifier: NCT04357093    
Other Study ID Numbers: Grape seed extract
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: January 26, 2021
Last Verified: January 2021

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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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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Grape Seed Extract
Sodium Fluoride
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action