Remineralizing Efficacy of Grape Seed Extract in Management of White Spot Lesion in Post Orthodontic Treated Patients.
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|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Dental Caries||Other: Grape seed extract mouthwash Other: Sodium fluoride mouthwash||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
- 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)
- Satisfaction of the patient: questionnaire [ Time Frame: After 6 months ]Using binary questionnaire ( Yes/No)