Dental CariesNCT03966378
Reminerlization Potential of GSE Gel versusCPP-ACP in Carious White Spot Lesions in Post Orthodontic Patients
A study testing Grape seeds extract and Casein-phosphopeptide/amorphous-calcium phosphate in people with Dental Caries, run by Cairo University.
Trial summary
Assess the effectiveness of applying grape seed extract (GSE) gel versus casein phosphopeptide-amorphous calcium phosphate (MI) paste on remineralization of white spot lesion (WSLs) in post orthodontic patients. Read more about this study
- Who is it for?
- Ages 13 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Grape seeds extract and Casein-phosphopeptide/amorphous-calcium phosphate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 3 Oct 2019to 10 May 2020
- 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 35 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.
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 (including any milk-related allergies or any medical condition involving kidneys or salivary glands).
- Presence of restorations or cavities in any anterior teeth or enamel hypoplasia, dental fluorosis, or intrinsic and extrinsic pigmentation.
About this study
Official title: Reminerlization Potential of Grape Seeds Extract Gel Versus Casein Phosphopeptide-amorphous Calcium Phosphate in Carious White Spot Lesions in Post Orthodontic Patients
Assess the effectiveness of applying grape seed extract (GSE) gel versus casein phosphopeptide-amorphous calcium phosphate (MI) paste on remineralization of white spot lesion (WSLs) in post orthodontic patients.
Read the detailed description
The development of WSLs is a challenging problem in the track of orthodontic treatment. Especially in patients wearing fixed orthodontic appliances, plaque accumulation increases around brackets and bands and the pH on dental surfaces becomes acidic.
These early lesions are willing to remineralization, arrest, reharden and revert to healthy enamel condition through a remineralization process involving the diffusion of minerals into the defective tooth structure. For this purpose various remineralizing agents such as casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) and grape seed extract (GSE) have been used.
This research is conducted for early intervention and treatment of the white spot lesions by non-invasive method.
- Conditions
- Dental Caries
- Being tested
- Grape seeds extract, Casein-phosphopeptide/amorphous-calcium phosphate
- 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 seeds extractOther
Grape seeds extract powder
Casein-phosphopeptide/amorphous-calcium phosphateOther
CPP-ACP paste
| Study group | Role | What they receive |
|---|---|---|
| Grape seeds extract | Experimental | Every week the grape seeds extract (gel) put into the tray and apply it to the upper teeth of the participant. Receives: Other: Grape seeds extract |
| Casein-phosphopeptide/amorphous-calcium phosphate | Active comparator | CPP-ACP paste apply to the teeth twice daily. Receives: Other: Casein-phosphopeptide/amorphous-calcium phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative changes of white spot lesions
changes in fluorescence of white spot lesions will be evaluated after reminerlization by using diagnodent device by score (0-20).
Measured: evaluation of tooth surface changes at baseline and at 4, 12, and 24 weeks after starting treatment .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start3 Oct 2019 (estimated)
- Primary completion6 Apr 2020 (estimated)
- Study completion10 May 2020 (estimated)
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aseel Saleh Omeran, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966378
- Sponsor's protocol ID
- 607
- Status last verified
- May 2019
- First submitted
- 22 May 2019
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reminerlization Potential of Grape Seeds Extract Gel Versus Casein Phosphopeptide-amorphous Calcium Phosphate in Carious White Spot Lesions in Post Orthodontic Patients
- ClinicalTrials.gov ID
- NCT03966378
- Acronym / sponsor ID
- 607
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Oct 2019 (estimated)
- Primary completion
- 6 Apr 2020 (estimated)
- Study completion
- 10 May 2020 (estimated)
- First posted
- 29 May 2019 (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.
Assess the effectiveness of applying grape seed extract (GSE) gel versus casein phosphopeptide-amorphous calcium phosphate (MI) paste on remineralization of white spot lesion (WSLs) in post orthodontic patients.
Detailed description
The development of WSLs is a challenging problem in the track of orthodontic treatment. Especially in patients wearing fixed orthodontic appliances, plaque accumulation increases around brackets and bands and the pH on dental surfaces becomes acidic.
These early lesions are willing to remineralization, arrest, reharden and revert to healthy enamel condition through a remineralization process involving the diffusion of minerals into the defective tooth structure. For this purpose various remineralizing agents such as casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) and grape seed extract (GSE) have been used.
This research is conducted for early intervention and treatment of the white spot lesions by non-invasive method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grape seeds extract | Experimental | Other: Grape seeds extractEvery week the grape seeds extract (gel) put into the tray and apply it to the upper teeth of the participant. |
| Casein-phosphopeptide/amorphous-calcium phosphate | Active comparator | Other: Casein-phosphopeptide/amorphous-calcium phosphateCPP-ACP paste apply to the teeth twice daily. |
Who may qualify
- Ages
- 13 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Presence of at least two WSLs on the labial surfaces of six maxillary anterior teeth that were not present before orthodontic therapy.
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 (including any milk-related allergies or any medical condition involving kidneys or salivary glands).
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 seeds extractGrape seeds extract powder | Other | Grape seeds extract |
| Casein-phosphopeptide/amorphous-calcium phosphateCPP-ACP paste | Other | Casein-phosphopeptide/amorphous-calcium phosphate |
Primary outcome
Quantitative changes of white spot lesions
Time frame: evaluation of tooth surface changes at baseline and at 4, 12, and 24 weeks after starting treatment .
changes in fluorescence of white spot lesions will be evaluated after reminerlization by using diagnodent device by score (0-20).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Grape seeds extract and Casein-phosphopeptide/amorphous-calcium phosphate in people with Dental Caries, run by Cairo University.
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 1 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: status not confirmed, as of the sponsor's last update on 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Quantitative changes of white spot lesions (time frame: evaluation of tooth surface changes at baseline and at 4, 12, and 24 weeks 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 29 May 2019.