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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Remineralizing Efficacy of Grape Seed Extract Oil Versus Fluoride Mouthwash in Management of Post-Orthodontic White Spot Lesions: Randomized Clinical Trial

Conditions
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Dental Caries

Intervention / Treatment
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* Other: Grape seed extract mouthwash
* Other: Sodium fluoride mouthwash


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Grape seed extract mouthwash<br>Grape seed extract mouth wash 15% concentration | Other: Grape seed extract mouthwash<br>* Mouthwash 15% grape seed extract<br>* Other names: Grape seed extract;|
| Active Comparator: Sodium fluoride mouthwash<br>Sodium fluoride mouthwash 1000 ppm | Other: Sodium fluoride mouthwash<br>* Sodium fluoride mouthwash<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction of the patient: questionnaire | Using binary questionnaire ( Yes/No) | After 6 months |