Remineralizing Efficacy of Grape Seed Extract in Management of White Spot Lesion in Post Orthodontic Treated Patients.
Evaluation of Remineralizing Efficacy of Grape Seed Extract Oil Versus Fluoride Mouthwash in Management of Post-Orthodontic White Spot Lesions: Randomized Clinical Trial
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2020
CompletedFirst Posted
Study publicly available on registry
April 22, 2020
CompletedStudy Start
First participant enrolled
February 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2021
CompletedJanuary 17, 2025
January 1, 2025
6 months
April 17, 2020
January 15, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Remineralization of white spot lesions
changes in fluorescence of white spot lesions will be evaluated after reminerlization by using Diagnodent scoring (0-20)
Evaluation of tooth surface changes at baseline and at 1, 3 and 6 months after starting treatment .
Secondary Outcomes (1)
Satisfaction of the patient: questionnaire
After 6 months
Study Arms (2)
Grape seed extract mouthwash
EXPERIMENTALGrape seed extract mouth wash 15% concentration
Sodium fluoride mouthwash
ACTIVE COMPARATORSodium fluoride mouthwash 1000 ppm
Interventions
Mouthwash 15% grape seed extract
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo University
Cairo, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Master degree studnet, Conservative Dentistry Department, Faculty of Dentistry, Cairo University.
Study Record Dates
First Submitted
April 17, 2020
First Posted
April 22, 2020
Study Start
February 10, 2021
Primary Completion
August 10, 2021
Study Completion
August 30, 2021
Last Updated
January 17, 2025
Record last verified: 2025-01