White Spot Lesions [Initial Caries] on Smooth Surface of ToothNCT06976385
Clinical Impact of White Tea and Wheat Grass on Color Enhancement of White Spot Lesions
A study testing White tea and Wheat grass solution in people with White Spot Lesions [Initial Caries] on Smooth Surface of Tooth, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The current study aimed to evaluate the color change potential of wheat grass and white tea on post orthodontic white spot lesions (WSLs). Materials and Methods: A total of 12 patients were divided into two main groups A1 and A2 according to type of treatment agent (n=6). Read more about this study
- Who is it for?
- Ages 15 to 18 years
- Conditions the study is for
- White Spot Lesions [Initial Caries] on Smooth Surface of Tooth
- What is being tested?
- White tea and Wheat grass solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2023to 15 Dec 2023
- 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 15 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age range between 15-18 years.
- Good oral hygiene
- Obvious area of WSL was found around the fixed orthodontic brackets.
- Included teeth should be free of any restorations
Who cannot join
- : 1. Cavitated enamel surface. 2. Presence of any restorations including the labial surface of the involved teeth.
- 3. Presence of any environmental or developmental enamel defect such as enamel hypoplasia, fluorosis, stains, and trauma sites on teeth before orthodontic treatment. 4. Allergy to tea and/or wheat
Trial locations and contacts
1 site in 1 country.
About this study
The current study aimed to evaluate the color change potential of wheat grass and white tea on post orthodontic white spot lesions (WSLs). Materials and Methods: A total of 12 patients were divided into two main groups A1 and A2 according to type of treatment agent (n=6). The A1 group used 10% white tea solution while the A2 group used 10% wheat grass solution. Shade evaluation was conducted using VITA Easyshade V spectrophotometer. Baseline L a b values of WSLs were detected right after orthodontic bracket removal. Patients were requested to rinse with the treatment agent for 1 minute, twice per day. The mean L,a,b values were recorded after 1 month and after 3 months . ΔE values were calculated between baseline, 1 month and 3 months after the treatment agent application and subjected to statistical analysis using one way ANOVA with p\>0.05. Also, Standardized photographs were taken at baseline, after 1 and 3 months. Each WSL was photographed twice with the 1st photograph taken of wet teeth and the 2nd one after prolonged air-drying in order to perform ICDAS II scoring.
- Being tested
- White tea, Wheat grass solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White teaDietary supplement
White tea mouth rinse applied topically twice daily.
Wheat grass solutionDietary supplement
wheat grass solution mouth rinse applied topically twice daily.
| Study group | Role | What they receive |
|---|---|---|
| White tea | Experimental | Participants prepared white tea mouth rinse to rinse thoroughly . At each rinsing, 10 mL of the solution was swished around the mouth for about 60 s and then spited This procedure was performed twice per day for 1 , and 3 months Receives: Dietary Supplement: White tea |
| Wheat grass solution | Experimental | Participants prepared wheat grass solution mouth rinse to rinse thoroughly . At each rinsing, 10 mL of the solution was swished around the mouth for about 60 s and then spited This procedure was performed twice per day for 1 , and 3 months Receives: Dietary Supplement: Wheat grass solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
ΔE values were calculated
The mean L,a,b values were recorded . ΔE values were calculated
Measured: after 1 month and after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start15 Oct 2023
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for White Spot Lesions [Initial Caries] on Smooth Surface of ToothStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Mohamed Taha Elnems, NewGiza University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976385
- Sponsor's protocol ID
- REC-CL-23-14b
- Status last verified
- May 2025
- First submitted
- 9 May 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact of White Tea and Wheat Grass on Color Enhancement of White Spot Lesions
- ClinicalTrials.gov ID
- NCT06976385
- Acronym / sponsor ID
- REC-CL-23-14b
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 16 May 2025 (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.
The current study aimed to evaluate the color change potential of wheat grass and white tea on post orthodontic white spot lesions (WSLs). Materials and Methods: A total of 12 patients were divided into two main groups A1 and A2 according to type of treatment agent (n=6). The A1 group used 10% white tea solution while the A2 group used 10% wheat grass solution. Shade evaluation was conducted using VITA Easyshade V spectrophotometer. Baseline L a b values of WSLs were detected right after orthodontic bracket removal. Patients were requested to rinse with the treatment agent for 1 minute, twice per day. The mean L,a,b values were recorded after 1 month and after 3 months . ΔE values were calculated between baseline, 1 month and 3 months after the treatment agent application and subjected to statistical analysis using one way ANOVA with p\>0.05. Also, Standardized photographs were taken at baseline, after 1 and 3 months. Each WSL was photographed twice with the 1st photograph taken of wet teeth and the 2nd one after prolonged air-drying in order to perform ICDAS II scoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| White tea | Experimental | Dietary Supplement: White teaParticipants prepared white tea mouth rinse to rinse thoroughly . At each rinsing, 10 mL of the solution was swished around the mouth for about 60 s and then spited This procedure was performed twice per day for 1 , and 3 months |
| Wheat grass solution | Experimental | Dietary Supplement: Wheat grass solutionParticipants prepared wheat grass solution mouth rinse to rinse thoroughly . At each rinsing, 10 mL of the solution was swished around the mouth for about 60 s and then spited This procedure was performed twice per day for 1 , and 3 months |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age range between 15-18 years.
- Good oral hygiene
- Obvious area of WSL was found around the fixed orthodontic brackets.
- Included teeth should be free of any restorations
Key exclusion criteria (2 listed)
- : 1. Cavitated enamel surface. 2. Presence of any restorations including the labial surface of the involved teeth.
- 3. Presence of any environmental or developmental enamel defect such as enamel hypoplasia, fluorosis, stains, and trauma sites on teeth before orthodontic treatment. 4. Allergy to tea and/or wheat
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 |
|---|---|---|
| White teaWhite tea mouth rinse applied topically twice daily. | Dietary supplement | White tea |
| Wheat grass solutionwheat grass solution mouth rinse applied topically twice daily. | Dietary supplement | Wheat grass solution |
Primary outcome
ΔE values were calculated
Time frame: after 1 month and after 3 months
The mean L,a,b values were recorded . ΔE values were calculated
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 16 May 2025.
- Individual participant dataSharing planned: No
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 White tea and Wheat grass solution in people with White Spot Lesions [Initial Caries] on Smooth Surface of Tooth, run by Al-Azhar 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 4 inclusion and 2 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 16 May 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?
ΔE values were calculated (time frame: after 1 month and after 3 months). 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 16 May 2025.