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

Primary Purpose

Dental Caries

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Grape seed extract mouthwash
Sodium fluoride mouthwash
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries

Eligibility Criteria

13 Years - 30 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Grape seed extract mouthwash

    Sodium fluoride mouthwash

    Arm Description

    Grape seed extract mouth wash 15% concentration

    Sodium fluoride mouthwash 1000 ppm

    Outcomes

    Primary Outcome Measures

    Remineralization of white spot lesions
    changes in fluorescence of white spot lesions will be evaluated after reminerlization by using Diagnodent scoring (0-20)

    Secondary Outcome Measures

    Satisfaction of the patient: questionnaire
    Using binary questionnaire ( Yes/No)

    Full Information

    First Posted
    April 17, 2020
    Last Updated
    January 25, 2021
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04357093
    Brief Title
    Remineralizing Efficacy of Grape Seed Extract in Management of White Spot Lesion in Post Orthodontic Treated Patients.
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2021 (Anticipated)
    Primary Completion Date
    August 2021 (Anticipated)
    Study Completion Date
    September 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Caries

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Grape seed extract mouthwash
    Arm Type
    Experimental
    Arm Description
    Grape seed extract mouth wash 15% concentration
    Arm Title
    Sodium fluoride mouthwash
    Arm Type
    Active Comparator
    Arm Description
    Sodium fluoride mouthwash 1000 ppm
    Intervention Type
    Other
    Intervention Name(s)
    Grape seed extract mouthwash
    Other Intervention Name(s)
    Grape seed extract
    Intervention Description
    Mouthwash 15% grape seed extract
    Intervention Type
    Other
    Intervention Name(s)
    Sodium fluoride mouthwash
    Intervention Description
    Sodium fluoride mouthwash
    Primary Outcome Measure Information:
    Title
    Remineralization of white spot lesions
    Description
    changes in fluorescence of white spot lesions will be evaluated after reminerlization by using Diagnodent scoring (0-20)
    Time Frame
    Evaluation of tooth surface changes at baseline and at 1, 3 and 6 months after starting treatment .
    Secondary Outcome Measure Information:
    Title
    Satisfaction of the patient: questionnaire
    Description
    Using binary questionnaire ( Yes/No)
    Time Frame
    After 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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