Bleaching Effect and Postoperative Sensitivity of Strawberry ExtractNCT06287060
Bleaching Effect of Strawberry Extract Versus Hydrogen Peroxide in Patients With Extrinsic Staining
A study testing strawberry extract. in people with Bleaching Effect and Postoperative Sensitivity of Strawberry Extract, run by Cairo University.
Trial summary
with limited evidence based information in literature about using Strawberry extract for teeth bleaching in patients with extrinsic staining , it is beneficial to evaluate this new material using a randomized controlled clinical trial to test the null hypothesis that this extract will have the same effect as Hydrogen… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bleaching Effect and Postoperative Sensitivity of Strawberry Extract
- What is being tested?
- strawberry extract.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Dec 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant inclusion criteria:
- At least 18 years old.
- Good general and oral health.
- six present maxillary anterior teeth.
- Tooth inclusion criteria:
- yellowing of teeth due to age.
- stains due to coffee or tea.
- light tetracycline stain.
Who cannot join
- participant exclusion criteria:
- patients undergoing radiotherapy or chemotherapy.
- Pregnant females or breast feeders.
- Bruxism and patients who reported tooth sensitivity.
- Tooth exclusion criteria:
- Hypoplastic enamel.
Show all 12Show fewer
- carious lesion.
- sensitive recession area or sensitive tooth.
- Amalgam staining.
- Non vital tooth.
- Discolration due to pulp trauma or necrosis.
- presence of non carious cervical lesion.
About this study
Official title: BLEACHING EFFECT OF STRAWBERRY EXTRACT VERSUS HYDROGEN PEROXIDE IN PATIENTS WITH EXRINSIC STAINING A RANDOMIZED CLINICAL TRIAL
with limited evidence based information in literature about using Strawberry extract for teeth bleaching in patients with extrinsic staining , it is beneficial to evaluate this new material using a randomized controlled clinical trial to test the null hypothesis that this extract will have the same effect as Hydrogen peroxide regarding the bleaching effect and hypersensitivity.
Read the detailed description
The whitening effect of strawberry is due to the presence of malic acid, which acts as a natural astringent to remove surface discoloration. The ellagic acid content in strawberry is ranging from 0.43 to 4.64 mg/g dry weight. The more amount of ellagic acid will produce more potential OH clusters as a powerful oxidizer thus make the more effective bleaching process. Ellagic acid releases the OH and H radicals which will react with the tooth enamel organic molecules and disrupt the electron conjugation, as well as changing the energy absorption in the tooth enamel organic molecules to form smaller organic molecules with a lighter color. Ellagic acid has an OH cluster, not COOH cluster like any other acids. The electronegativity of the OH group will be easier to break and react with the organic molecules of tooth enamel.
- Being tested
- strawberry extract.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
strawberry extract.Other
strawberry has a whitening effect due to its content of ellagic and maleic acids. the presence of acidic components namely ascorbic acid may increase the surface energy by removing the surface debris, thereby allowing the citric and maleic acids to penetrate into tooth surface to remove the surface stains.
| Study group | Role | What they receive |
|---|---|---|
| patients with extrinsic staining will be treated with strawberry extract. | Experimental | Not described Receives: Other: strawberry extract. |
| patients with extrinsic staining will be treated with Hydrogen peroxide bleaching agent. | Active comparator | Not described Receives: Other: strawberry extract. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleaching effect of strawberry extract versus Hydrogen peroxide.
objective assessment for the bleaching effect by spectrophotometer.
Measured: immediately , one week and one month after application.
Secondary outcomes (1)
post operative sensitivity.
Tooth sensitivity is scored according to the VRS verbal Rating scale, where 0=none, 1=mild, 2=moderate, 3=considerable, and 4=severe
Measured: immediately after bleaching agent removal , 24 hours after application.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study startJul 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bleaching Effect and Postoperative Sensitivity of Strawberry ExtractStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randa Khaled Mostafa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287060
- Sponsor's protocol ID
- Strawberry extract
- Status last verified
- Feb 2024
- First submitted
- 23 Feb 2024
- Last updated
- 29 Feb 2024
- 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 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BLEACHING EFFECT OF STRAWBERRY EXTRACT VERSUS HYDROGEN PEROXIDE IN PATIENTS WITH EXRINSIC STAINING A RANDOMIZED CLINICAL TRIAL
- ClinicalTrials.gov ID
- NCT06287060
- Acronym / sponsor ID
- Strawberry extract
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 29 Feb 2024 (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.
with limited evidence based information in literature about using Strawberry extract for teeth bleaching in patients with extrinsic staining , it is beneficial to evaluate this new material using a randomized controlled clinical trial to test the null hypothesis that this extract will have the same effect as Hydrogen peroxide regarding the bleaching effect and hypersensitivity.
Detailed description
The whitening effect of strawberry is due to the presence of malic acid, which acts as a natural astringent to remove surface discoloration. The ellagic acid content in strawberry is ranging from 0.43 to 4.64 mg/g dry weight. The more amount of ellagic acid will produce more potential OH clusters as a powerful oxidizer thus make the more effective bleaching process. Ellagic acid releases the OH and H radicals which will react with the tooth enamel organic molecules and disrupt the electron conjugation, as well as changing the energy absorption in the tooth enamel organic molecules to form smaller organic molecules with a lighter color. Ellagic acid has an OH cluster, not COOH cluster like any other acids. The electronegativity of the OH group will be easier to break and react with the organic molecules of tooth enamel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with extrinsic staining will be treated with strawberry extract. | Experimental | Other: strawberry extract. |
| patients with extrinsic staining will be treated with Hydrogen peroxide bleaching agent. | Active comparator | Other: strawberry extract. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- At least 18 years old.
- Good general and oral health.
- six present maxillary anterior teeth.
- yellowing of teeth due to age.
- stains due to coffee or tea.
Key exclusion criteria (12 listed)
- patients undergoing radiotherapy or chemotherapy.
- Pregnant females or breast feeders.
- Bruxism and patients who reported tooth sensitivity.
- Hypoplastic enamel.
- carious lesion.
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 |
|---|---|---|
| strawberry extract.strawberry has a whitening effect due to its content of ellagic and maleic acids. the presence of acidic components namely ascorbic acid may increase the surface energy by removing the surface debris, thereby allowing the citric and maleic acids to penetrate into tooth surface to remove the surface stains. | Other | patients with extrinsic staining will be treated with Hydrogen peroxide bleaching agent., patients with extrinsic staining will be treated with strawberry extract. |
Primary outcome
Bleaching effect of strawberry extract versus Hydrogen peroxide.
Time frame: immediately , one week and one month after application.
objective assessment for the bleaching effect by spectrophotometer.
1 secondary outcome
post operative sensitivity.
Time frame: immediately after bleaching agent removal , 24 hours after application.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
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 strawberry extract. in people with Bleaching Effect and Postoperative Sensitivity of Strawberry Extract, 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 8 inclusion and 12 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 Feb 2024. 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?
Bleaching effect of strawberry extract versus Hydrogen peroxide. (time frame: immediately , one week and one month after application.). 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 Feb 2024.