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

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04357093
Collaborator
(none)
40
2
7

Study Details

Study Description

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
  • Other: Grape seed extract mouthwash
  • Other: Sodium fluoride mouthwash
N/A

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.

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Aug 1, 2021
Anticipated Study Completion Date :
Sep 1, 2021

Arms and Interventions

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 Names:
  • Grape seed extract
  • Active Comparator: Sodium fluoride mouthwash

    Sodium fluoride mouthwash 1000 ppm

    Other: Sodium fluoride mouthwash
    Sodium fluoride mouthwash

    Outcome Measures

    Primary Outcome Measures

    1. Remineralization of white spot lesions [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 [After 6 months]

      Using binary questionnaire ( Yes/No)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    13 Years to 30 Years
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nada Abd El Sattar Mohamed Kotb, Master degree studnet, Conservative Dentistry Department, Faculty of Dentistry, Cairo University., Cairo University
    ClinicalTrials.gov Identifier:
    NCT04357093
    Other Study ID Numbers:
    • Grape seed extract
    First Posted:
    Apr 22, 2020
    Last Update Posted:
    Jan 26, 2021
    Last Verified:
    Jan 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 26, 2021