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CompletedNCT04357093Updated Jan 17, 2025

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

An interventional study of Grape seed extract mouthwash and Sodium fluoride mouthwash in Dental Caries, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 13 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-17.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
13 Years to 30 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dental Caries

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03

In context

Dental Caries

1,137 studies on the registry are indexed under Dental Caries; 201 are open to participants now.

This study's enrollment of 40 is below the median of 60 across 936 interventional studies indexed under Dental Caries.

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Lead sponsor

Cairo University is the lead sponsor of 4,907 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Grape seed extract mouthwash

    Grape seed extract mouth wash 15% concentration

    Other: Grape seed extract mouthwash

  • Active comparator
    Sodium fluoride mouthwash

    Sodium fluoride mouthwash 1000 ppm

    Other: Sodium fluoride mouthwash

Interventions

  • OtherGrape seed extract mouthwash

    Mouthwash 15% grape seed extract

    Also known as: Grape seed extract

  • OtherSodium fluoride mouthwash

    Sodium fluoride mouthwash

06

What researchers measure

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)

    Time frame: 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

    Using binary questionnaire ( Yes/No)

    Time frame: After 6 months

07

Study locations

1 site
  • Cairo University
    Cairo, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04357093
Lead sponsor
Cairo University
Responsible party
Nada Abd El Sattar Mohamed Kotb (Master degree studnet, Conservative Dentistry Department, Faculty of Dentistry, Cairo University., Cairo University) — Principal investigator
First posted
Apr 22, 2020
Start date
Feb 10, 2021
Primary completion
Aug 10, 2021
Completion
Aug 30, 2021
Last update
Jan 17, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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