Dental CariesNCT04357093
Remineralizing Efficacy of Grape Seed Extract in Management of White Spot Lesion in Post Orthodontic Treated Patients.
A study testing Grape seed extract mouthwash and Sodium fluoride mouthwash in people with Dental Caries, run by Cairo University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 13 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Grape seed extract mouthwash and Sodium fluoride mouthwash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Feb 2021to 30 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Dental Caries
- Being tested
- Grape seed extract mouthwash, Sodium fluoride mouthwash
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grape seed extract mouthwashOther
Also called Grape seed extract
Mouthwash 15% grape seed extract
Sodium fluoride mouthwashOther
Sodium fluoride mouthwash
| Study group | Role | What they receive |
|---|---|---|
| Grape seed extract mouthwash | Experimental | Grape seed extract mouth wash 15% concentration Receives: Other: Grape seed extract mouthwash |
| Sodium fluoride mouthwash | Active comparator | Sodium fluoride mouthwash 1000 ppm Receives: Other: Sodium fluoride mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remineralization of white spot lesions
changes in fluorescence of white spot lesions will be evaluated after reminerlization by using Diagnodent scoring (0-20)
Measured: 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)
Measured: After 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start10 Feb 2021
- Primary completion10 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Abd El Sattar Mohamed Kotb, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357093
- Sponsor's protocol ID
- Grape seed extract
- Status last verified
- Jan 2025
- First submitted
- 17 Apr 2020
- Last updated
- 17 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04357093
- Acronym / sponsor ID
- Grape seed extract
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 22 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grape seed extract mouthwash | Experimental | Other: Grape seed extract mouthwashGrape seed extract mouth wash 15% concentration |
| Sodium fluoride mouthwash | Active comparator | Other: Sodium fluoride mouthwashSodium fluoride mouthwash 1000 ppm |
Who may qualify
- Ages
- 13 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grape seed extract mouthwashAlso: Grape seed extractMouthwash 15% grape seed extract | Other | Grape seed extract mouthwash |
| Sodium fluoride mouthwashSodium fluoride mouthwash | Other | Sodium fluoride mouthwash |
Primary outcome
Remineralization of white spot lesions
Time frame: 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)
1 secondary outcome
Satisfaction of the patient: questionnaire
Time frame: After 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grape seed extract mouthwash and Sodium fluoride mouthwash in people with Dental Caries, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remineralization of white spot lesions (time frame: Evaluation of tooth surface changes at baseline and at 1, 3 and 6 months after starting treatment .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.