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

NCT ID: NCT04357093

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-10
• Study Completion Date: 2021-08-30

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.

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.

Conditions

Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Grape seed extract mouthwash

Grape seed extract mouth wash 15% concentration

Group Type: EXPERIMENTAL

Grape seed extract mouthwash

Intervention Type: OTHER

Mouthwash 15% grape seed extract

Sodium fluoride mouthwash

Sodium fluoride mouthwash 1000 ppm

Group Type: ACTIVE_COMPARATOR

Sodium fluoride mouthwash

Intervention Type: OTHER

Sodium fluoride mouthwash

Interventions

Grape seed extract mouthwash

Mouthwash 15% grape seed extract

Intervention Type: OTHER

Sodium fluoride mouthwash

Sodium fluoride mouthwash

Intervention Type: OTHER

Other Intervention Names

Grape seed extract

Eligibility Criteria

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nada Abd El Sattar Mohamed Kotb

Master degree studnet, Conservative Dentistry Department, Faculty of Dentistry, Cairo University.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Grape seed extract

Identifier Type: -

Identifier Source: org_study_id