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
About this trial
This is an interventional treatment trial for Dental Caries
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.
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
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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