Discoloration, ToothNCT06582069
Bleaching Effect of Solo and Combined Kiwi Extract and Ozone and Their Impact on Enamel
A study testing Bleaching in people with Discoloration, Tooth, run by Al-Azhar University.
Trial summary
ozone therapy has been extensively used in dentistry to manage wounds healing, dental caries, oral lichen planus, gingivitis and periodontitis, halitosis, osteonecrosis of the jaw, post-surgical pain, plaque and biofilms, root canal treatment, dentin hypersensitivity, tempro-mandibular joint disorders and teeth… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Discoloration, Tooth
- What is being tested?
- Bleaching
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 1 Jan 2026
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A total of the 40 participants aged between (18-35 years) with no gender prediction.
- The participation will be entirely voluntary, and a signed statement of informed consent will be obtained prior to the start of the study.
- Systemically healthy subject based on medical and drug histories, a subject requiring scaling and polishing with moderate calculus with at least two non-adjacent hypersensitive teeth with Schiff scale scores \>1 with air blast stimulus.
- Access to sound maxillary anterior teeth.
- Vitapan classical shades should be A3 or darker and lighter shades are not included.
Who cannot join
- Participants with poor oral hygiene.
- Participants with missing anterior teeth.
- Participants with unrealistic expectations.
- Participants with dental caries, those undergoing orthodontic treatment.
- Participants with a history of periodontal treatment, pregnant or lactating women and individuals with a history of asthma.
- Those who are allergic to kiwi or ozone skin therapy were excluded from the study.
- Smokers are excluded from the present study.
About this study
ozone therapy has been extensively used in dentistry to manage wounds healing, dental caries, oral lichen planus, gingivitis and periodontitis, halitosis, osteonecrosis of the jaw, post-surgical pain, plaque and biofilms, root canal treatment, dentin hypersensitivity, tempro-mandibular joint disorders and teeth whitening, And based on the above, in this study kiwi extract and ozone gas will be used individually and combined to evaluate the resultant effects on bleaching, enamel microhardness and micromorphology.
- Conditions
- Discoloration, Tooth
- Being tested
- Bleaching
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BleachingDevice
Bleaching
| Study group | Role | What they receive |
|---|---|---|
| bleaching with 2% kiwi extract. | Experimental | The fresh pulpy kiwi will be bought 200 gm of kiwi fruits were cleaned, cut into round shapes and blended with 15 mL of distilled water in a blender to obtain about 50 mL of kiwi concentrate.
This concentrate will be filtered and then transferred into a cooling centrifuge to be processed at 2000 rpm for about 20 minutes at a temperature of 40°C.
The extract thus collected will be stored at 4°C till further use. Receives: Device: Bleaching |
| bleaching using 2,350 ppm ozone gas. | Experimental | A 2,350 ppm ozone concentration at a 615 cc per minute flow rate will be supplied by a well-known ozone producing machine.
The ppm of ozone supplied will be verified via an ozone detection device, and the ozone flow rate will be verified by a flow meter directly before the start of the experiment.
Ozone gas will be distributed to the tooth surfaces through special trays to assure a perfect seal to prevent any ozone leakage and to be safely employed to humans Receives: Device: Bleaching |
| bleaching with 2% kiwi extract followed By 2,350 ppm ozone gas. | Experimental | The fresh pulpy kiwi will be bought 200 gm of kiwi fruits were cleaned, cut into round shapes and blended with 15 mL of distilled water in a blender to obtain about 50 mL of kiwi concentrate.
This concentrate will be filtered and then transferred into a cooling centrifuge to be processed at 2000 rpm for about 20 minutes at a temperature of 40°C.
The extract thus collected will be stored at 4°C till further use. A 2,350 ppm ozone concentration at a 615 cc per minute flow rate will be supplied by a well-known ozone producing machine.
The ppm of ozone supplied will be verified via an ozone detection device, and the ozone flow rate will be verified by a flow meter directly before the start of the experiment.
Ozone gas will be distributed to the tooth surfaces through special trays to assure a perfect seal to prevent any ozone leakage and to be safely employed to humans. Receives: Device: Bleaching |
| bleaching with 38% hydrogen peroxide. | Experimental | Application of 38% H2O2 gel for 20 minutes. Then, the H2O2 gel will be removed, and teeth will be sprayed for 10 seconds with water from a 3-in-1 syringe Receives: Device: Bleaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Color change assessment
all participants will be requested to return after 24 hours to permit rehydration of tooth surfaces before shade assessment Tooth Shades will then record using colorimeter. The color change (ΔE) will be calculated using the formula: ΔE= {(ΔL) 2+ (Δa) 2+ (Δb)
Measured: 24 Hours
Color change assessment
all participants will be requested to return after one month for tooth shades recording using colorimeter. The color change (ΔE) will be calculated using the formula: ΔE= {(ΔL) 2+ (Δa) 2+ (Δb) at one month
Measured: one month
Color change assessment
all participants will be requested to return after one month for tooth shades recording using colorimeter. The color change (ΔE) will be calculated using the formula: ΔE= {(ΔL) 2+ (Δa) 2+ (Δb) at three months
Measured: three month
Color change assessment
all participants will be requested to return after one month for tooth shades recording using colorimeter. The color change (ΔE) will be calculated using the formula: ΔE= {(ΔL) 2+ (Δa) 2+ (Δb) at six months
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Discoloration, 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
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Bedier El Lakanay, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582069
- Sponsor's protocol ID
- 24/3/2024
- Status last verified
- Aug 2024
- First submitted
- 24 Aug 2024
- Last updated
- 3 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bleaching Effect of Solo and Combined Kiwi Extract and Ozone and Their Impact on Enamel
- ClinicalTrials.gov ID
- NCT06582069
- Acronym / sponsor ID
- 24/3/2024
- Conditions
- Discoloration, Tooth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 3 Sep 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.
ozone therapy has been extensively used in dentistry to manage wounds healing, dental caries, oral lichen planus, gingivitis and periodontitis, halitosis, osteonecrosis of the jaw, post-surgical pain, plaque and biofilms, root canal treatment, dentin hypersensitivity, tempro-mandibular joint disorders and teeth whitening, And based on the above, in this study kiwi extract and ozone gas will be used individually and combined to evaluate the resultant effects on bleaching, enamel microhardness and micromorphology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| bleaching with 2% kiwi extract. | Experimental | Device: BleachingThe fresh pulpy kiwi will be bought 200 gm of kiwi fruits were cleaned, cut into round shapes and blended with 15 mL of distilled water in a blender to obtain about 50 mL of kiwi concentrate. This concentrate will be filtered and then transferred into a cooling centrifuge to be processed at 2000 rpm for about 20 minutes at a temperature of 40°C. The extract thus collected will be stored at 4°C till further use. |
| bleaching using 2,350 ppm ozone gas. | Experimental | Device: BleachingA 2,350 ppm ozone concentration at a 615 cc per minute flow rate will be supplied by a well-known ozone producing machine. The ppm of ozone supplied will be verified via an ozone detection device, and the ozone flow rate will be verified by a flow meter directly before the start of the experiment. Ozone gas will be distributed to the tooth surfaces through special trays to assure a perfect seal to prevent any ozone leakage and to be safely employed to humans |
| bleaching with 2% kiwi extract followed By 2,350 ppm ozone gas. | Experimental | Device: BleachingThe fresh pulpy kiwi will be bought 200 gm of kiwi fruits were cleaned, cut into round shapes and blended with 15 mL of distilled water in a blender to obtain about 50 mL of kiwi concentrate. This concentrate will be filtered and then transferred into a cooling centrifuge to be processed at 2000 rpm for about 20 minutes at a temperature of 40°C. The extract thus collected will be stored at 4°C till further use. A 2,350 ppm ozone concentration at a 615 cc per minute flow rate will be supplied by a well-known ozone producing machine. The ppm of ozone supplied will be verified via an ozone detection device, and the ozone flow rate will be verified by a flow meter directly before the start of the experiment. Ozone gas will be distributed to the tooth surfaces through special trays to assure a perfect seal to prevent any ozone leakage and to be safely employed to humans. |
| bleaching with 38% hydrogen peroxide. | Experimental | Device: BleachingApplication of 38% H2O2 gel for 20 minutes. Then, the H2O2 gel will be removed, and teeth will be sprayed for 10 seconds with water from a 3-in-1 syringe |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- A total of the 40 participants aged between (18-35 years) with no gender prediction.
- The participation will be entirely voluntary, and a signed statement of informed consent will be obtained prior to the start of the study.
- Systemically healthy subject based on medical and drug histories, a subject requiring scaling and polishing with moderate calculus with at least two non-adjacent hypersensitive teeth with Schiff scale scores \>1 with air blast stimulus.
- Access to sound maxillary anterior teeth.
- Vitapan classical shades should be A3 or darker and lighter shades are not included.
Key exclusion criteria (7 listed)
- Participants with poor oral hygiene.
- Participants with missing anterior teeth.
- Participants with unrealistic expectations.
- Participants with dental caries, those undergoing orthodontic treatment.
- Participants with a history of periodontal treatment, pregnant or lactating women and individuals with a history of asthma.
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 |
|---|---|---|
| BleachingBleaching | Device | bleaching using 2,350 ppm ozone gas., bleaching with 2% kiwi extract followed By 2,350 ppm ozone gas., bleaching with 2% kiwi extract., bleaching with 38% hydrogen peroxide. |
Primary outcome
Color change assessment
Time frame: 24 Hours
all participants will be requested to return after 24 hours to permit rehydration of tooth surfaces before shade assessment Tooth Shades will then record using colorimeter. The color change (ΔE) will be calculated using the formula: ΔE= {(ΔL) 2+ (Δa) 2+ (Δb)
Color change assessment
Time frame: one month
all participants will be requested to return after one month for tooth shades recording using colorimeter. The color change (ΔE) will be calculated using the formula: ΔE= {(ΔL) 2+ (Δa) 2+ (Δb) at one month
Color change assessment
Time frame: three month
all participants will be requested to return after one month for tooth shades recording using colorimeter. The color change (ΔE) will be calculated using the formula: ΔE= {(ΔL) 2+ (Δa) 2+ (Δb) at three months
Color change assessment
Time frame: six months
all participants will be requested to return after one month for tooth shades recording using colorimeter. The color change (ΔE) will be calculated using the formula: ΔE= {(ΔL) 2+ (Δa) 2+ (Δb) at six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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 Bleaching in people with Discoloration, Tooth, run by Al-Azhar 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 5 inclusion and 7 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 3 Sep 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?
Color change assessment (time frame: 24 Hours). The study lists 4 primary outcomes in all. 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 3 Sep 2024.