AbrasionNCT05619315
Enamel Abrasion and Stain Removal Efficacy
A study testing Charcoal -based whitening toothpaste and Calcium carbonate /perlite containing whitening toothpaste. in people with Abrasion and Discoloration, Tooth, run by Cairo University.
Trial summary
Enamel abrasion and stain removal efficacy of two whitening toothpastes Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Abrasion, Discoloration, Tooth
- What is being tested?
- Charcoal -based whitening toothpaste and Calcium carbonate /perlite containing whitening toothpaste.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Dec 2022to Oct 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In vivo:
- Patients inclusion:
- Adult male and female patients ≥18 years.
- Good oral and general health and oral hygiene have at least eight natural anterior teeth (incisors and canines) assessable for extrinsic stain and be available for all study appointments.
- Tooth inclusion:
- Vital anterior maxillary and mandibular teeth free of caries or restorations, no cervical lesions and no periodontal disease.
Show all 10Show fewer
- In vitro:
- Teeth inclusion criteria:
- Intact, free of caries or restorations.
- No cervical lesions .
Who cannot join
- In vivo:
- Patients exclusion:
- Uncooperative behavior.
- Patients allergic to tooth paste material.
- Patient with history of medical disease, drug therapies or any other serious relevant problem.
- Pregnant or breastfeeding women.
Show all 23Show fewer
- Patients with fixed orthodontic appliances
- Patients who had professional tooth whitening, within the last six months.
- Patients who had significant amounts of calculus on facial surfaces of the incisors/canines.
- Patients who had undergone professional periodontal treatment within the previous six months or used mouth rinses for the treatment/ control of a periodontal condition.
- Patients who had advanced periodontal disease on anterior teeth.
- Xerostomic patients.
- Patients who used medications which could affect saliva flow or cause staining.
- Patients who had undergone dental prophylaxis within 8 weeks of screening.
- Patients who used minocycline or doxycycline within 30 days of screening or between screening and baseline
- Tooth exclusion:
- Intrinsically Discolored teeth caused by tetracycline, fluorosis, hypocalcification hyperplasia, endodontic treatment (or requiring endodontic treatment).
- Restorations in anterior teeth, parafunctional habits or tooth sensitivity.
- Non- vital teeth
- In vitro:
- Teeth exclusion criteria:
- Intrinsically Discolored teeth caused by tetracycline, fluorosis, hyperplasia, endodontic treatment .
- Restorations in teeth
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Enamel Abrasion and Stain Removal Efficacy of Two Whitening Toothpastes
Enamel abrasion and stain removal efficacy of two whitening toothpastes
Read the detailed description
Statement of the problem:
Access to in-office treatments is restricted to a lot of population. Therefore, there has been an interest in developing methods so that patients can remove stains and apply tooth whitening at home. Accordingly, toothpastes, due to their ease of use and low cost, have been used as vehicles for whitening agents as an alternative to home/office whitening.
Hydrogen peroxide is the most commonly used agent for whitening teeth, which is used in various concentrations according to various techniques at home and office. Bleaching of teeth in office is done at a high concentration of Hydrogen peroxide for a specified period of time. In addition to conventional whitening treatments, over-the-counter products, including gels, toothpastes, bleaching strips, mouthwashes, and pens with different Hydrogen peroxide levels, have been developed. In-office teeth whitening is one of the more costly forms of teeth whitening and the concentration of the bleaching element is higher, it is better monitored by a professional.
Whitening toothpaste is probably the one of the most affordable options for someone looking to whiten their teeth at home, which contain abrasive and chemical agents and have the ability to remove external stains from the tooth. The abrasiveness of toothpastes depends on the hardness, size, and shape of abrasive particles. Furthermore, factors such as the brushing technique, brushing pressure, toothbrush hardness, and the number of brush strokes affect tooth abrasion. Abrasive agents include silica, phosphates, carbonates, and bicarbonates Chemical agents present in whitening toothpastes are sodium citrate, phosphate salt, which react with chromogenic molecules of superficial dental stains and eliminate them from the tooth surface.
Whitening toothpastes include different active ingredients in their composition. It normally contain a higher amount of abrasives and detergents than do conventional toothpastes In this sense, it is important to point out that toothpastes with higher amounts of abrasives may produce increased surface roughness in dental tissues, or restorations, or even tooth sensitivity, especially if they are used routinely
Rationale:
Today, active charcoal is added to toothpastes which are marketed as charcoal toothpastes. The first report on the use of charcoal in oral and dental hygiene has been attributed to Hippocrates in ancient Greece. Charcoal is used as powder, soot, coal, and ash in different countries. Charcoal-based products are used in medical treatments, such as its use as an antidote for acute poisoning, drug overdose, skin infections, Charcoal is used legally for the coloring of food in China, Japan, and Korea to improve health.
Activated charcoal is produced as a natural method of the partial oxidation of various materials. High-porosity activated charcoal has the ability to exchange ion in the mouth through nanopores and can attach to tooth enamel and remove tooth-coloring agents (because of its capacity of adsorbing pigments, chromophores, and stains from the tooth surface). The application of this product has been suggested to eliminate some dental coloring agents. Charcoal can help tooth whitening through tooth abrasion.
- Conditions
- Abrasion, Discoloration, Tooth
- Being tested
- Charcoal -based whitening toothpaste, Calcium carbonate /perlite containing whitening toothpaste.
- Keywords
- abrasion, toothpaste, stain, whitening
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Charcoal -based whitening toothpasteOther
The labial surface of anterior teeth will be brushed by the circular brushing technique twice daily (morning and after 6 hours) for at least 1 minute using charcoal containing toothpaste. Soft bristles toothbrushes will provided to all patients. After 1 month, re-evaluation of the stains will be performed and the data will be recorded.
Calcium carbonate /perlite containing whitening toothpaste.Other
The labial surface of anterior teeth will be brushed by the circular brushing technique twice daily (morning and after 6hours) for at least 1 minute using (calcium carbonate /perlite) containing toothpaste. Soft bristles toothbrushes will provided to all patients. After 1 month, re-evaluation of the stains will be performed and the data will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Charcoal -based whitening toothpaste. | Experimental | The labial surface of anterior teeth will be brushed by the circular brushing technique twice daily (morning and after 6 hours) for at least 1 minute using charcoal containing toothpaste. Soft bristles toothbrushes will provided to all patients. After 1 month, re-evaluation of the stains will be performed and the data will be recorded. Receives: Other: Charcoal -based whitening toothpaste |
| Calcium carbonate /perlite containing whitening toothpaste. | Active comparator | The labial surface of anterior teeth will be brushed by the circular brushing technique twice daily (morning and after 6hours) for at least 1 minute using (calcium carbonate /perlite) containing toothpaste. Soft bristles toothbrushes will provided to all patients. After 1 month, re-evaluation of the stains will be performed and the data will be recorded. Receives: Other: Calcium carbonate /perlite containing whitening toothpaste. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stain score
mcpherson modification of the stain index and area x intensity
Measured: T0: Baseline
Stain score
mcpherson modification of the stain index and area x intensity
Measured: T1: 4 weeks
Secondary outcomes (2)
Surface roughness
Atomic Force Microscopy
Measured: T0: Baseline
Surface roughness
Atomic Force Microscopy
Measured: T1: 3 minutes equivalent to 2 times a day for one month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study startDec 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for AbrasionStudies 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
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Osama Metwally, Cairo University
- Investigators
- Iman Ibrahim El Sayad, prof, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619315
- Sponsor's protocol ID
- Charcoal based whitening
- Status last verified
- Nov 2022
- First submitted
- 9 Nov 2022
- Last updated
- 16 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ghassemi A, Hooper W, Vorwerk L, Domke T, DeSciscio P, Nathoo S. Effectiveness of a new dentifrice with baking soda and peroxide in removing extrinsic stain and whitening teeth. J Clin Dent. 2012;23(3):86-91.
PubMed 23210419Watts A, Addy M. Tooth discolouration and staining: a review of the literature. Br Dent J. 2001 Mar 24;190(6):309-16. doi: 10.1038/sj.bdj.4800959.
PubMed 11325156Lima DA, Silva AL, Aguiar FH, Liporoni PC, Munin E, Ambrosano GM, Lovadino JR. In vitro assessment of the effectiveness of whitening dentifrices for the removal of extrinsic tooth stains. Braz Oral Res. 2008 Apr-Jun;22(2):106-11. doi: 10.1590/s1806-83242008000200003.
PubMed 18622478Kalyana P, Shashidhar A, Meghashyam B, Sreevidya KR, Sweta S. Stain removal efficacy of a novel dentifrice containing papain and Bromelain extracts--an in vitro study. Int J Dent Hyg. 2011 Aug;9(3):229-33. doi: 10.1111/j.1601-5037.2010.00473.x. Epub 2010 Jul 1.
PubMed 21356017Collins LZ, Naeeni M, Schafer F, Brignoli C, Schiavi A, Roberts J, Colgan P. The effect of a calcium carbonate/perlite toothpaste on the removal of extrinsic tooth stain in two weeks. Int Dent J. 2005;55(3 Suppl 1):179-82. doi: 10.1111/j.1875-595x.2005.tb00056.x.
PubMed 16004250Patil PA, Ankola AV, Hebbal MI, Patil AC. Comparison of effectiveness of abrasive and enzymatic action of whitening toothpastes in removal of extrinsic stains - a clinical trial. Int J Dent Hyg. 2015 Feb;13(1):25-9. doi: 10.1111/idh.12090. Epub 2014 Jul 21.
PubMed 25046241Zafar MS, Ahmed N. Nanomechanical characterization of exfoliated and retained deciduous incisors. Technol Health Care. 2014;22(6):785-93. doi: 10.3233/THC-140852.
PubMed 25134963Litonjua LA, Andreana S, Bush PJ, Tobias TS, Cohen RE. Noncarious cervical lesions and abfractions: a re-evaluation. J Am Dent Assoc. 2003 Jul;134(7):845-50. doi: 10.14219/jada.archive.2003.0282.
PubMed 12892441Johannsen G, Tellefsen G, Johannsen A, Liljeborg A. The importance of measuring toothpaste abrasivity in both a quantitative and qualitative way. Acta Odontol Scand. 2013 May-Jul;71(3-4):508-17. doi: 10.3109/00016357.2012.696693. Epub 2012 Jul 2.
PubMed 22746180Carey CM. Tooth whitening: what we now know. J Evid Based Dent Pract. 2014 Jun;14 Suppl:70-6. doi: 10.1016/j.jebdp.2014.02.006. Epub 2014 Feb 13.
PubMed 24929591Ozkan P, Kansu G, Ozak ST, Kurtulmus-Yilmaz S, Kansu P. Effect of bleaching agents and whitening dentifrices on the surface roughness of human teeth enamel. Acta Odontol Scand. 2013 May-Jul;71(3-4):488-97. doi: 10.3109/00016357.2012.696691. Epub 2012 Jul 2.
PubMed 22747485Barbieri GM, Mota EG, Rodrigues-Junior SA, Burnett LH Jr. Effect of whitening dentifrices on the surface roughness of commercial composites. J Esthet Restor Dent. 2011 Oct;23(5):338-45. doi: 10.1111/j.1708-8240.2011.00426.x. Epub 2011 May 9.
PubMed 21977958Gerlach RW, Barker ML, Tucker HL. Clinical response of three whitening products having different peroxide delivery: comparison of tray, paint-on gel, and dentifrice. J Clin Dent. 2004;15(4):112-7.
PubMed 15794456Joiner A. Review of the extrinsic stain removal and enamel/dentine abrasion by a calcium carbonate and perlite containing whitening toothpaste. Int Dent J. 2006 Aug;56(4):175-80. doi: 10.1111/j.1875-595x.2006.tb00091.x.
PubMed 16972390Brooks JK, Bashirelahi N, Reynolds MA. Charcoal and charcoal-based dentifrices: A literature review. J Am Dent Assoc. 2017 Sep;148(9):661-670. doi: 10.1016/j.adaj.2017.05.001. Epub 2017 Jun 7.
PubMed 28599961
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enamel Abrasion and Stain Removal Efficacy of Two Whitening Toothpastes
- ClinicalTrials.gov ID
- NCT05619315
- Acronym / sponsor ID
- Charcoal based whitening
- Conditions
- Abrasion, Discoloration, Tooth
- Keywords
- abrasion, toothpaste, stain, whitening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 16 Nov 2022 (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.
Enamel abrasion and stain removal efficacy of two whitening toothpastes
Detailed description
Statement of the problem:
Access to in-office treatments is restricted to a lot of population. Therefore, there has been an interest in developing methods so that patients can remove stains and apply tooth whitening at home. Accordingly, toothpastes, due to their ease of use and low cost, have been used as vehicles for whitening agents as an alternative to home/office whitening.
Hydrogen peroxide is the most commonly used agent for whitening teeth, which is used in various concentrations according to various techniques at home and office. Bleaching of teeth in office is done at a high concentration of Hydrogen peroxide for a specified period of time. In addition to conventional whitening treatments, over-the-counter products, including gels, toothpastes, bleaching strips, mouthwashes, and pens with different Hydrogen peroxide levels, have been developed. In-office teeth whitening is one of the more costly forms of teeth whitening and the concentration of the bleaching element is higher, it is better monitored by a professional.
Whitening toothpaste is probably the one of the most affordable options for someone looking to whiten their teeth at home, which contain abrasive and chemical agents and have the ability to remove external stains from the tooth. The abrasiveness of toothpastes depends on the hardness, size, and shape of abrasive particles. Furthermore, factors such as the brushing technique, brushing pressure, toothbrush hardness, and the number of brush strokes affect tooth abrasion. Abrasive agents include silica, phosphates, carbonates, and bicarbonates Chemical agents present in whitening toothpastes are sodium citrate, phosphate salt, which react with chromogenic molecules of superficial dental stains and eliminate them from the tooth surface.
Whitening toothpastes include different active ingredients in their composition. It normally contain a higher amount of abrasives and detergents than do conventional toothpastes In this sense, it is important to point out that toothpastes with higher amounts of abrasives may produce increased surface roughness in dental tissues, or restorations, or even tooth sensitivity, especially if they are used routinely
Rationale:
Today, active charcoal is added to toothpastes which are marketed as charcoal toothpastes. The first report on the use of charcoal in oral and dental hygiene has been attributed to Hippocrates in ancient Greece. Charcoal is used as powder, soot, coal, and ash in different countries. Charcoal-based products are used in medical treatments, such as its use as an antidote for acute poisoning, drug overdose, skin infections, Charcoal is used legally for the coloring of food in China, Japan, and Korea to improve health.
Activated charcoal is produced as a natural method of the partial oxidation of various materials. High-porosity activated charcoal has the ability to exchange ion in the mouth through nanopores and can attach to tooth enamel and remove tooth-coloring agents (because of its capacity of adsorbing pigments, chromophores, and stains from the tooth surface). The application of this product has been suggested to eliminate some dental coloring agents. Charcoal can help tooth whitening through tooth abrasion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Charcoal -based whitening toothpaste. | Experimental | Other: Charcoal -based whitening toothpasteThe labial surface of anterior teeth will be brushed by the circular brushing technique twice daily (morning and after 6 hours) for at least 1 minute using charcoal containing toothpaste. Soft bristles toothbrushes will provided to all patients. After 1 month, re-evaluation of the stains will be performed and the data will be recorded. |
| Calcium carbonate /perlite containing whitening toothpaste. | Active comparator | Other: Calcium carbonate /perlite containing whitening toothpaste.The labial surface of anterior teeth will be brushed by the circular brushing technique twice daily (morning and after 6hours) for at least 1 minute using (calcium carbonate /perlite) containing toothpaste. Soft bristles toothbrushes will provided to all patients. After 1 month, re-evaluation of the stains will be performed and the data will be recorded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients inclusion:
- Vital anterior maxillary and mandibular teeth free of caries or restorations, no cervical lesions and no periodontal disease.
- Intact, free of caries or restorations.
- No cervical lesions .
Key exclusion criteria (23 listed)
- Uncooperative behavior.
- Patients allergic to tooth paste material.
- Patient with history of medical disease, drug therapies or any other serious relevant problem.
- Pregnant or breastfeeding women.
- Patients with fixed orthodontic appliances
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 |
|---|---|---|
| Charcoal -based whitening toothpasteThe labial surface of anterior teeth will be brushed by the circular brushing technique twice daily (morning and after 6 hours) for at least 1 minute using charcoal containing toothpaste. Soft bristles toothbrushes will provided to all patients. After 1 month, re-evaluation of the stains will be performed and the data will be recorded. | Other | Charcoal -based whitening toothpaste. |
| Calcium carbonate /perlite containing whitening toothpaste.The labial surface of anterior teeth will be brushed by the circular brushing technique twice daily (morning and after 6hours) for at least 1 minute using (calcium carbonate /perlite) containing toothpaste. Soft bristles toothbrushes will provided to all patients. After 1 month, re-evaluation of the stains will be performed and the data will be recorded. | Other | Calcium carbonate /perlite containing whitening toothpaste. |
Primary outcome
Stain score
Time frame: T0: Baseline
mcpherson modification of the stain index and area x intensity
Stain score
Time frame: T1: 4 weeks
mcpherson modification of the stain index and area x intensity
2 secondary outcomes
Surface roughness
Time frame: T0: Baseline
Surface roughness
Time frame: T1: 3 minutes equivalent to 2 times a day for one month.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Background: PubMed 23210419Ghassemi A, Hooper W, Vorwerk L, Domke T, DeSciscio P, Nathoo S. Effectiveness of a new dentifrice with baking soda and peroxide in removing extrinsic stain and whitening teeth. J Clin Dent. 2012;23(3):86-91.
- Background: PubMed 11325156Watts A, Addy M. Tooth discolouration and staining: a review of the literature. Br Dent J. 2001 Mar 24;190(6):309-16. doi: 10.1038/sj.bdj.4800959.
- Background: PubMed 18622478Lima DA, Silva AL, Aguiar FH, Liporoni PC, Munin E, Ambrosano GM, Lovadino JR. In vitro assessment of the effectiveness of whitening dentifrices for the removal of extrinsic tooth stains. Braz Oral Res. 2008 Apr-Jun;22(2):106-11. doi: 10.1590/s1806-83242008000200003.
- Background: PubMed 21356017Kalyana P, Shashidhar A, Meghashyam B, Sreevidya KR, Sweta S. Stain removal efficacy of a novel dentifrice containing papain and Bromelain extracts--an in vitro study. Int J Dent Hyg. 2011 Aug;9(3):229-33. doi: 10.1111/j.1601-5037.2010.00473.x. Epub 2010 Jul 1.
- Background: PubMed 16004250Collins LZ, Naeeni M, Schafer F, Brignoli C, Schiavi A, Roberts J, Colgan P. The effect of a calcium carbonate/perlite toothpaste on the removal of extrinsic tooth stain in two weeks. Int Dent J. 2005;55(3 Suppl 1):179-82. doi: 10.1111/j.1875-595x.2005.tb00056.x.
- Background: PubMed 25046241Patil PA, Ankola AV, Hebbal MI, Patil AC. Comparison of effectiveness of abrasive and enzymatic action of whitening toothpastes in removal of extrinsic stains - a clinical trial. Int J Dent Hyg. 2015 Feb;13(1):25-9. doi: 10.1111/idh.12090. Epub 2014 Jul 21.
- Background: PubMed 25134963Zafar MS, Ahmed N. Nanomechanical characterization of exfoliated and retained deciduous incisors. Technol Health Care. 2014;22(6):785-93. doi: 10.3233/THC-140852.
- Background: PubMed 12892441Litonjua LA, Andreana S, Bush PJ, Tobias TS, Cohen RE. Noncarious cervical lesions and abfractions: a re-evaluation. J Am Dent Assoc. 2003 Jul;134(7):845-50. doi: 10.14219/jada.archive.2003.0282.
- Background: PubMed 22746180Johannsen G, Tellefsen G, Johannsen A, Liljeborg A. The importance of measuring toothpaste abrasivity in both a quantitative and qualitative way. Acta Odontol Scand. 2013 May-Jul;71(3-4):508-17. doi: 10.3109/00016357.2012.696693. Epub 2012 Jul 2.
- Background: PubMed 24929591Carey CM. Tooth whitening: what we now know. J Evid Based Dent Pract. 2014 Jun;14 Suppl:70-6. doi: 10.1016/j.jebdp.2014.02.006. Epub 2014 Feb 13.
- Background: PubMed 22747485Ozkan P, Kansu G, Ozak ST, Kurtulmus-Yilmaz S, Kansu P. Effect of bleaching agents and whitening dentifrices on the surface roughness of human teeth enamel. Acta Odontol Scand. 2013 May-Jul;71(3-4):488-97. doi: 10.3109/00016357.2012.696691. Epub 2012 Jul 2.
- Background: PubMed 21977958Barbieri GM, Mota EG, Rodrigues-Junior SA, Burnett LH Jr. Effect of whitening dentifrices on the surface roughness of commercial composites. J Esthet Restor Dent. 2011 Oct;23(5):338-45. doi: 10.1111/j.1708-8240.2011.00426.x. Epub 2011 May 9.
- Individual participant dataSharing planned: No
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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.
Iman Ibrahim El Sayad, prof study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Charcoal -based whitening toothpaste and Calcium carbonate /perlite containing whitening toothpaste. in people with Abrasion and Discoloration, Tooth, 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 10 inclusion and 23 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 16 Nov 2022. 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?
Contact Mohamed Osama Metwally (00201008488587, Mohamedelbadry@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stain score (time frame: T0: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05619315, which also lists 22 linked publications.
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 Nov 2022.