Tooth AbrasionNCT05650840
Enamel Abrasion and Stain Removal Efficacy of Two Whitening Toothpastes: An In-vitro and In-vivo Trial
A study testing Charcoal based whitening toothpaste (signal charcoal white& Detox toothpaste Unilever Mashreq - Egypt and Calcium carbonate /perlite containing whitening toothpaste (signal whitening moonlight toothpaste Unilever Mashreq - Egypt). in people with Tooth Abrasion, run by Cairo University.
Trial summary
The aim of the study is to clinically evaluate the efficacy of external stain removal of an activated charcoal based tooth paste versus calcium carbonate /perlite tooth paste. Additionally, to investigate enamel surface abrasion for both toothpastes in vitro. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Abrasion
- What is being tested?
- Charcoal based whitening toothpaste (signal charcoal white& Detox toothpaste Unilever Mashreq - Egypt and Calcium carbonate /perlite containing whitening toothpaste (signal whitening moonlight toothpaste Unilever Mashreq - Egypt).
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 1 Aug 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
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.
- 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 inclusion:
▪ Vital anterior maxillary and mandibular teeth free of caries or restorations, no cervical lesions and no periodontal disease.
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 inclusion criteria:
- Intact, free of caries or restorations.
- No cervical lesions
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.
Mohamed R El-Bialy, Post Phd contact
About this study
Official title: Enamel Abrasion and Stain Removal Efficacy of Charcoal -Based and Calcium Carbonate /Perlite Whitening Toothpastes: A Randomized Clinical Trial and In-vitro Trial
The aim of the study is to clinically evaluate the efficacy of external stain removal of an activated charcoal based tooth paste versus calcium carbonate /perlite tooth paste. Additionally, to investigate enamel surface abrasion for both toothpastes in vitro.
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
- Tooth Abrasion
- Being tested
- Charcoal based whitening toothpaste (signal charcoal white& Detox toothpaste Unilever Mashreq - Egypt, Calcium carbonate /perlite containing whitening toothpaste (signal whitening moonlight toothpaste Unilever Mashreq - Egypt).
- Keywords
- Charcoal based toothpaste, External tooth stains, Teeth abrasion
- Medical subject headings
- Tooth Abrasion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Charcoal based whitening toothpaste (signal charcoal white& Detox toothpaste Unilever Mashreq - EgyptProcedure or surgery
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 (Oral-B). After 1 month, re-evaluation of the stains will be performed and the data will be recorded.
Intervention drug : whitening toothpaste charcoal based whitening toothpaste compared to calcium carbonate and perlite whitening toothpaste
FOR IN VITRO:
Human premolars will be obtained from volunteers due to orthodontic reasons. Teeth will be divided into two equal groups (n:18) according to the toothpaste used. Teeth will be brushed with an electric tooth brush (Oral-B PRO 500) that will be held in a holder to standardize the position to the tooth surface for 3 minutes equivalent to 2 times a day for one month. Teeth will be prepared for AFM examination
Calcium carbonate /perlite containing whitening toothpaste (signal whitening moonlight toothpaste Unilever Mashreq - Egypt).Procedure or surgery
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 (Oral-B). After 1 month, re-evaluation of the stains will be performed and the data will be recorded. The main operator will perform the tooth brushing procedures for all the patients himself twice daily.
FOR IN VITRO:
Human premolars will be obtained from volunteers due to orthodontic reasons. Teeth will be divided into two equal groups (n:18) according to the toothpaste used. Teeth will be brushed with an electric tooth brush(Oral-B PRO 500) that will be held in a holder to standardize the position to the tooth surface for 3 minutes equivalent to 2 times a day for one month. Teeth will be prepared for AFM examination Device used is atomic force microscopy to determine enamel abrasion after brushing
| Study group | Role | What they receive |
|---|---|---|
| Charcoal -based whitening toothpaste | Experimental | signal charcoal white\& Detox toothpaste Unilever Mashreq - Egypt Receives: Procedure: Charcoal based whitening toothpaste (signal charcoal white& Detox toothpaste Unilever Mashreq - Egypt |
| Calcium carbonate /perlite containing whitening toothpaste | Active comparator | signal whitening moonlight toothpaste Unilever Mashreq - Egypt Receives: Procedure: Calcium carbonate /perlite containing whitening toothpaste (signal whitening moonlight toothpaste Unilever Mashreq - Egypt). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stain scores as per Macpherson modification of the Lobene stain index
Stain scores will be recorded as per the Macpherson modified Lobene Stain Index area x intensity (AXI). Each tooth will be divided into four areas for assessment: gingival, mesial, distal and body. The stain index will measure area and intensity of extrinsic tooth stain on the facial surfaces of the anterior teeth.
The criteria and codes for intensity were:
0: no stain present, natural tooth colouration
- faint stain
- clearly visible stain, orange to brown (moderate stain)
- dark stain, deep brown to black (heavy stain) The area (extent) of the stain was recorded only if an intensity score was of 2 or 3
The area criteria and codes for approximal and gingival sites were:
- thin line, can be continuous (< 1/3)
- thick line or band (>1/3, <2/3)
- covering total area (> 2/3)
Measured: Baseline
Stain scores as per Macpherson modification of the Lobene stain index
Stain scores will be recorded as per the Macpherson modified Lobene Stain Index area x intensity (AXI). Each tooth will be divided into four areas for assessment: gingival, mesial, distal and body. The stain index will measure area and intensity of extrinsic tooth stain on the facial surfaces of the anterior teeth.
The criteria and codes for intensity were:
0: no stain present, natural tooth colouration
- faint stain
- clearly visible stain, orange to brown (moderate stain)
- dark stain, deep brown to black (heavy stain) The area (extent) of the stain was recorded only if an intensity score was of 2 or 3
The area criteria and codes for approximal and gingival sites were:
- thin line, can be continuous (< 1/3)
- thick line or band (>1/3, <2/3)
- covering total area (> 2/3)
Measured: after four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start1 Jan 2023 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth 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
- Single blind
- Who is masked
- 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 I ElSayad, Study director, Cairo UniversityMohamed R El-Bialy, Post Phd, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05650840
- Sponsor's protocol ID
- CU-2022
- Status last verified
- Dec 2022
- First submitted
- 24 Nov 2022
- Last updated
- 28 Dec 2022
- Results posted
- 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 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enamel Abrasion and Stain Removal Efficacy of Charcoal -Based and Calcium Carbonate /Perlite Whitening Toothpastes: A Randomized Clinical Trial and In-vitro Trial
- ClinicalTrials.gov ID
- NCT05650840
- Acronym / sponsor ID
- CU-2022
- Conditions
- Tooth Abrasion
- Keywords
- Charcoal based toothpaste, External tooth stains, Teeth abrasion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 14 Dec 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.
The aim of the study is to clinically evaluate the efficacy of external stain removal of an activated charcoal based tooth paste versus calcium carbonate /perlite tooth paste. Additionally, to investigate enamel surface abrasion for both toothpastes in vitro.
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
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Charcoal -based whitening toothpaste | Experimental | Procedure: Charcoal based whitening toothpaste (signal charcoal white& Detox toothpaste Unilever Mashreq - Egyptsignal charcoal white\& Detox toothpaste Unilever Mashreq - Egypt |
| Calcium carbonate /perlite containing whitening toothpaste | Active comparator | Procedure: Calcium carbonate /perlite containing whitening toothpaste (signal whitening moonlight toothpaste Unilever Mashreq - Egypt).signal whitening moonlight toothpaste Unilever Mashreq - Egypt |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 toothpaste (signal charcoal white& Detox toothpaste Unilever Mashreq - EgyptThe 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 (Oral-B). After 1 month, re-evaluation of the stains will be performed and the data will be recorded. Intervention drug : whitening toothpaste charcoal based whitening toothpaste compared to calcium carbonate and perlite whitening toothpaste FOR IN VITRO: Human premolars will be obtained from volunteers due to orthodontic reasons. Teeth will be divided into two equal groups (n:18) according to the toothpaste used. Teeth will be brushed with an electric tooth brush (Oral-B PRO 500) that will be held in a holder to standardize the position to the tooth surface for 3 minutes equivalent to 2 times a day for one month. Teeth will be prepared for AFM examination | Procedure or surgery | Charcoal -based whitening toothpaste |
| Calcium carbonate /perlite containing whitening toothpaste (signal whitening moonlight toothpaste Unilever Mashreq - Egypt).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 (Oral-B). After 1 month, re-evaluation of the stains will be performed and the data will be recorded. The main operator will perform the tooth brushing procedures for all the patients himself twice daily. FOR IN VITRO: Human premolars will be obtained from volunteers due to orthodontic reasons. Teeth will be divided into two equal groups (n:18) according to the toothpaste used. Teeth will be brushed with an electric tooth brush(Oral-B PRO 500) that will be held in a holder to standardize the position to the tooth surface for 3 minutes equivalent to 2 times a day for one month. Teeth will be prepared for AFM examination Device used is atomic force microscopy to determine enamel abrasion after brushing | Procedure or surgery | Calcium carbonate /perlite containing whitening toothpaste |
Primary outcome
Stain scores as per Macpherson modification of the Lobene stain index
Time frame: Baseline
Stain scores will be recorded as per the Macpherson modified Lobene Stain Index area x intensity (AXI). Each tooth will be divided into four areas for assessment: gingival, mesial, distal and body. The stain index will measure area and intensity of extrinsic tooth stain on the facial surfaces of the anterior teeth. The criteria and codes for intensity were: 0: no stain present, natural tooth colouration 1. faint stain 2. clearly visible stain, orange to brown (moderate stain) 3. dark stain, deep brown to black (heavy stain) The area (extent) of the stain was recorded only if an intensity score was of 2 or 3 The area criteria and codes for approximal and gingival sites were: 1. thin line, can be continuous (< 1/3) 2. thick line or band (>1/3, <2/3) 3. covering total area (> 2/3)
Stain scores as per Macpherson modification of the Lobene stain index
Time frame: after four weeks
Stain scores will be recorded as per the Macpherson modified Lobene Stain Index area x intensity (AXI). Each tooth will be divided into four areas for assessment: gingival, mesial, distal and body. The stain index will measure area and intensity of extrinsic tooth stain on the facial surfaces of the anterior teeth. The criteria and codes for intensity were: 0: no stain present, natural tooth colouration 1. faint stain 2. clearly visible stain, orange to brown (moderate stain) 3. dark stain, deep brown to black (heavy stain) The area (extent) of the stain was recorded only if an intensity score was of 2 or 3 The area criteria and codes for approximal and gingival sites were: 1. thin line, can be continuous (< 1/3) 2. thick line or band (>1/3, <2/3) 3. covering total area (> 2/3)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Tooth Abrasion
Active, not recruiting
Clinical Evaluation of Resin Infiltration Treatment of MIH-affected Teeth in Pediatric Patients
Molar Incisor Hypomineralization
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.
Mohamed R El-Bialy, Post Phd contact
Iman I ElSayad study director
Cairo University
Mohamed R El-Bialy, Post Phd study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Charcoal based whitening toothpaste (signal charcoal white& Detox toothpaste Unilever Mashreq - Egypt and Calcium carbonate /perlite containing whitening toothpaste (signal whitening moonlight toothpaste Unilever Mashreq - Egypt). in people with Tooth Abrasion, 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?
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 28 Dec 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 Iman I ElSayad, Professor (0201005287368, iman.sayad@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 scores as per Macpherson modification of the Lobene stain index (time frame: 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?
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 28 Dec 2022.