ConsumptionNCT05605834
Assessment of Peroxide Level in Saliva During Teeth Bleaching With 9.5% Hydrogen Peroxide Gel
A study testing 9.5% hydrogen peroxide bleaching (POLA DAY advanced tooth whitening system, SDI) using a tray with reservoir and 9.5% hydrogen peroxide bleaching (POLA DAY advanced tooth whitening system, SDI) using a tray without reservoir. in people with Consumption and Toxicity, run by Cairo University at 1 site in Egypt.
Trial summary
Assessment of peroxide level in saliva during teeth bleaching with 9.5% hydrogen peroxide gel using a tray with reservoir versus a tray without reservoir. A randomized clinical trial Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Consumption, Toxicity
- What is being tested?
- 9.5% hydrogen peroxide bleaching (POLA DAY advanced tooth whitening system, SDI) using a tray with reservoir and 9.5% hydrogen peroxide bleaching (POLA DAY advanced tooth whitening system, SDI) using a tray without reservoir.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2023to 8 May 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- participants:
- Good general health.
- Adult patients aged 18-40 years.
- Absence of non-carious cervical lesions, active caries, gingival recession, or periodontal disease.
- Do not use orthodontics appliance or removable prosthesis.
- teeth:
- Maxillary anterior teeth without caries, restorations and/or endodontic treatment.
- Mild generalized staining.
Who cannot join
- participants:
- Smoking or alcohol dependent patients.
- Pregnancy and lactating women.
- Parafunctional habits or pathologies.
- Periapical alterations.
- Use of medicaments that alter salivary flow.
Show all 12Show fewer
- Patients who had already undergone tooth bleaching
- Patients with severe internal tooth discoloration as tetracycline stain, fluorosis or endodontic treatment.
- teeth:
- Tooth hypersensitivity.
- Presence of cracks or fractures.
- Periodontal affection sign and symptoms.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Peroxide Level in Saliva During Teeth Bleaching With 9.5% Hydrogen Peroxide Gel Using a Tray With Reservoir Versus a Tray Without Reservoir. A Randomized Clinical Trial
Assessment of peroxide level in saliva during teeth bleaching with 9.5% hydrogen peroxide gel using a tray with reservoir versus a tray without reservoir. A randomized clinical trial
Read the detailed description
Statement of the Problem
There is more concern about the possible adverse effect of bleaching agent, patients report gastrointestinal mucosal irritation e.g. a burning palate, throat and minor upsets in the stomach and intestine. Some adverse effects of hydrogen peroxide as a dental bleaching agent include dentin sensitivity and/or gingival irritation led by unstable and reactive H+ free radicals and low pH from prolonged use. Peroxide is a highly reactive substance which can damage oral soft tissues and hard tissues when present in high concentrations and with exposures of prolonged duration. Several researches have focused on the problem of gel ingestion and potential peroxide release in saliva
Rationale
Reservoirs are modifications in the tray molds to increase the amount of bleaching material carried by the bleaching tray, seeking greater bleaching efficacy. The use of reservoirs in the bleaching trays was initially seen as positive, since higher accumulation of material could provide the patient with greater treatment efficacy. stated that there is no significant difference between groups whitened with and without reservoirs for gingival irritation or tooth sensitivity. Most authors and bleaching gel manufacturers recommend the use of reservoirs to increase the amount of product available for bleaching and to allow for complete seating of the bleaching tray, although that the reservoirs decrease tray retention and increase lab fabrication time and cost. The presence of reservoirs decreases the retention of the tray, allowing more room for the gel but also reducing the adaptation of the tray. That may cause more leakage of the material, which may lead to more peroxide level in saliva. A major concern for clinicians was the potential toxicological effect of hydrogen peroxide contacting soft tissues. A safe hydrogen peroxide exposure level (no observed effect level) was determined with catalase-deficient mice, reporting a maximum dose of 26 mg/kg/d. This corresponds to the dose level in humans, considering the conventional uncertainty factor of 100-fold, of 0.26 mg/kg/d . The safety of hydrogen peroxide products used for at home bleaching regarding peroxide release in saliva has not been fully proven.
- Conditions
- Consumption, Toxicity
- Being tested
- 9.5% hydrogen peroxide bleaching (POLA DAY advanced tooth whitening system, SDI) using a tray with reservoir, 9.5% hydrogen peroxide bleaching (POLA DAY advanced tooth whitening system, SDI) using a tray without reservoir.
- Keywords
- hydrogen peroxide, reservoir, peroxide level, saliva, assessment, non reservoir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
9.5% hydrogen peroxide bleaching (POLA DAY advanced tooth whitening system, SDI) using a tray with reservoirOther
Patients will be randomly divided into two groups. Alginate impressions of maxillary dental arches of patients will be taken to obtain casts and produce the customized trays.
Reservoirs 1 mm thick will be created on the facial surfaces of anterior teeth, including the first premolars in the arches, applying a light-cured resin on the casts. The resin layer thickness will be standardized using a thickness gauge (1.5 mm thickness). Then, customized trays will be fabricated with 0.9-mm-thick vinyl acetate sheets using the thermoforming process. Trays will be precisely trimmed completely involving tooth surface (1 mm incisal or occlusal to gingival margin), and the adaptation will be verified on the casts. The trays will be placed over teeth to verify the adaptation in the patients' mouth.
9.5% hydrogen peroxide bleaching (POLA DAY advanced tooth whitening system, SDI) using a tray without reservoir.Other
Alginate impressions of maxillary dental arches of patients will be taken to obtain casts to produce the customized trays. Then, customized trays will be fabricated with no space for reservoir, with 0.9-mm-thick vinyl acetate sheets using the thermoforming process applying a light-cured resin on the casts. Trays will be precisely trimmed completely involving tooth surface (1 mm incisal or occlusal to gingival margin), and the adaptation will be verified on the casts. The trays will be placed over teeth to verify the adaptation in the participants' mouths.
| Study group | Role | What they receive |
|---|---|---|
| Hydrogen peroxide 9.5% bleaching using a tray with reservoir. | Experimental | 9.5% hydrogen peroxide bleaching (POLA DAY advanced tooth whitening system, SDI) using a tray with reservoir. Receives: Other: 9.5% hydrogen peroxide bleaching (POLA DAY advanced tooth whitening system, SDI) using a tray with reservoir |
| Hydrogen peroxide 9.5% bleaching using a tray without reservoir. | Active comparator | 9.5% hydrogen peroxide bleaching (POLA DAY advanced tooth whitening system, SDI) using a tray without reservoir. Receives: Other: 9.5% hydrogen peroxide bleaching (POLA DAY advanced tooth whitening system, SDI) using a tray without reservoir. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peroxide level in saliva
Peroxide concentration in saliva (mg/ml)
Measured: T0: 1 min after beginning of the bleaching procedure and application of the tray
Peroxide level in saliva
Peroxide concentration in saliva (mg/ml)
Measured: T1: 5 min after tray application
Peroxide level in saliva
Peroxide concentration in saliva (mg/ml)
Measured: T2: 10 min after tray application
Peroxide level in saliva
Peroxide concentration in saliva (mg/ml)
Measured: T3: 30 min after tray application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start10 Jan 2023
- Primary completion20 Feb 2024
- Study completion8 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for ConsumptionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anas Yousef Mohammad, Cairo University
- Investigators
- Iman Ibrahim El Sayad, prof, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05605834
- Sponsor's protocol ID
- a tray with reservoir
- Status last verified
- Jan 2025
- First submitted
- 29 Oct 2022
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alqahtani MQ. Tooth-bleaching procedures and their controversial effects: A literature review. Saudi Dent J. 2014 Apr;26(2):33-46. doi: 10.1016/j.sdentj.2014.02.002. Epub 2014 Mar 12.
PubMed 25408594Auschill TM, Hellwig E, Schmidale S, Sculean A, Arweiler NB. Efficacy, side-effects and patients' acceptance of different bleaching techniques (OTC, in-office, at-home). Oper Dent. 2005 Mar-Apr;30(2):156-63.
PubMed 15853099Bernardon JK, Sartori N, Ballarin A, Perdigao J, Lopes GC, Baratieri LN. Clinical performance of vital bleaching techniques. Oper Dent. 2010 Jan-Feb;35(1):3-10. doi: 10.2341/09-008CR.
PubMed 20166405Dahl JE, Pallesen U. Tooth bleaching--a critical review of the biological aspects. Crit Rev Oral Biol Med. 2003;14(4):292-304. doi: 10.1177/154411130301400406.
PubMed 12907697Marques DN, da Mata AD, Silveira JM, Marques JR, Amaral JP, Guilherme NF. Hydrogen peroxide release kinetics into saliva from different whitening products: a double-blind, randomized clinical trial. Clin Oral Investig. 2012 Feb;16(1):155-63. doi: 10.1007/s00784-010-0491-x. Epub 2011 Jan 8.
PubMed 21221681Geisinger S, Kwon SR, Qian F. Employment of Reservoirs in At-Home Whitening Trays: Efficacy and Efficiency in Tooth Whitening. J Contemp Dent Pract. 2015 May 1;16(5):383-8. doi: 10.5005/jp-journals-10024-1694.
PubMed 26162258Goldberg M, Grootveld M, Lynch E. Undesirable and adverse effects of tooth-whitening products: a review. Clin Oral Investig. 2010 Feb;14(1):1-10. doi: 10.1007/s00784-009-0302-4. Epub 2009 Jun 20.
PubMed 19543926Hannig C, Zech R, Henze E, Dorr-Tolui R, Attin T. Determination of peroxides in saliva--kinetics of peroxide release into saliva during home-bleaching with Whitestrips and Vivastyle. Arch Oral Biol. 2003 Aug;48(8):559-66. doi: 10.1016/s0003-9969(03)00102-x.
PubMed 12828984Hannig C, Zech R, Henze E, Dreier S, Attin T. Peroxide release into saliva from five different home bleaching systems in vivo. Am J Dent. 2005 Feb;18(1):13-8.
PubMed 15810475Hannig C, Willenbucher S, Becker K, Mahony C, Attin T. Recovery of peroxides in saliva during home bleaching--influence of smoking. J Oral Rehabil. 2006 Jul;33(7):533-41. doi: 10.1111/j.1365-2842.2005.01579.x.
PubMed 16774513Haywood VB. History, safety, and effectiveness of current bleaching techniques and applications of the nightguard vital bleaching technique. Quintessence Int. 1992 Jul;23(7):471-88.
PubMed 1410249Haywood VB, Leonard RH, Nelson CF, Brunson WD. Effectiveness, side effects and long-term status of nightguard vital bleaching. J Am Dent Assoc. 1994 Sep;125(9):1219-26. doi: 10.14219/jada.archive.1994.0154.
PubMed 7930184Haywood VB, Sword RJ. Tray bleaching status and insights. J Esthet Restor Dent. 2021 Jan;33(1):27-38. doi: 10.1111/jerd.12688. Epub 2020 Dec 5.
PubMed 33277968Javaheri DS, Janis JN. The efficacy of reservoirs in bleaching trays. Oper Dent. 2000 May-Jun;25(3):149-51.
PubMed 11203808Joiner A. The bleaching of teeth: a review of the literature. J Dent. 2006 Aug;34(7):412-9. doi: 10.1016/j.jdent.2006.02.002. Epub 2006 Mar 29.
PubMed 16569473
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Peroxide Level in Saliva During Teeth Bleaching With 9.5% Hydrogen Peroxide Gel Using a Tray With Reservoir Versus a Tray Without Reservoir. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05605834
- Acronym / sponsor ID
- a tray with reservoir
- Conditions
- Consumption, Toxicity
- Keywords
- hydrogen peroxide, reservoir, peroxide level, saliva, assessment, non reservoir
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 8 May 2024 (actual)
- First posted
- 4 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.
Assessment of peroxide level in saliva during teeth bleaching with 9.5% hydrogen peroxide gel using a tray with reservoir versus a tray without reservoir. A randomized clinical trial
Detailed description
Statement of the Problem
There is more concern about the possible adverse effect of bleaching agent, patients report gastrointestinal mucosal irritation e.g. a burning palate, throat and minor upsets in the stomach and intestine. Some adverse effects of hydrogen peroxide as a dental bleaching agent include dentin sensitivity and/or gingival irritation led by unstable and reactive H+ free radicals and low pH from prolonged use. Peroxide is a highly reactive substance which can damage oral soft tissues and hard tissues when present in high concentrations and with exposures of prolonged duration. Several researches have focused on the problem of gel ingestion and potential peroxide release in saliva
Rationale
Reservoirs are modifications in the tray molds to increase the amount of bleaching material carried by the bleaching tray, seeking greater bleaching efficacy. The use of reservoirs in the bleaching trays was initially seen as positive, since higher accumulation of material could provide the patient with greater treatment efficacy. stated that there is no significant difference between groups whitened with and without reservoirs for gingival irritation or tooth sensitivity. Most authors and bleaching gel manufacturers recommend the use of reservoirs to increase the amount of product available for bleaching and to allow for complete seating of the bleaching tray, although that the reservoirs decrease tray retention and increase lab fabrication time and cost. The presence of reservoirs decreases the retention of the tray, allowing more room for the gel but also reducing the adaptation of the tray. That may cause more leakage of the material, which may lead to more peroxide level in saliva. A major concern for clinicians was the potential toxicological effect of hydrogen peroxide contacting soft tissues. A safe hydrogen peroxide exposure level (no observed effect level) was determined with catalase-deficient mice, reporting a maximum dose of 26 mg/kg/d. This corresponds to the dose level in humans, considering the conventional uncertainty factor of 100-fold, of 0.26 mg/kg/d . The safety of hydrogen peroxide products used for at home bleaching regarding peroxide release in saliva has not been fully proven.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrogen peroxide 9.5% bleaching using a tray with reservoir. | Experimental | Other: 9.5% hydrogen peroxide bleaching (POLA DAY advanced tooth whitening system, SDI) using a tray with reservoir9.5% hydrogen peroxide bleaching (POLA DAY advanced tooth whitening system, SDI) using a tray with reservoir. |
| Hydrogen peroxide 9.5% bleaching using a tray without reservoir. | Active comparator | Other: 9.5% hydrogen peroxide bleaching (POLA DAY advanced tooth whitening system, SDI) using a tray without reservoir.9.5% hydrogen peroxide bleaching (POLA DAY advanced tooth whitening system, SDI) using a tray without reservoir. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- participants:
- Maxillary anterior teeth without caries, restorations and/or endodontic treatment.
- Mild generalized staining.
Key exclusion criteria (12 listed)
- participants:
- Tooth hypersensitivity.
- Presence of cracks or fractures.
- Periodontal affection sign and symptoms.
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 |
|---|---|---|
| 9.5% hydrogen peroxide bleaching (POLA DAY advanced tooth whitening system, SDI) using a tray with reservoirPatients will be randomly divided into two groups. Alginate impressions of maxillary dental arches of patients will be taken to obtain casts and produce the customized trays. Reservoirs 1 mm thick will be created on the facial surfaces of anterior teeth, including the first premolars in the arches, applying a light-cured resin on the casts. The resin layer thickness will be standardized using a thickness gauge (1.5 mm thickness). Then, customized trays will be fabricated with 0.9-mm-thick vinyl acetate sheets using the thermoforming process. Trays will be precisely trimmed completely involving tooth surface (1 mm incisal or occlusal to gingival margin), and the adaptation will be verified on the casts. The trays will be placed over teeth to verify the adaptation in the patients' mouth. | Other | Hydrogen peroxide 9.5% bleaching using a tray with reservoir. |
| 9.5% hydrogen peroxide bleaching (POLA DAY advanced tooth whitening system, SDI) using a tray without reservoir.Alginate impressions of maxillary dental arches of patients will be taken to obtain casts to produce the customized trays. Then, customized trays will be fabricated with no space for reservoir, with 0.9-mm-thick vinyl acetate sheets using the thermoforming process applying a light-cured resin on the casts. Trays will be precisely trimmed completely involving tooth surface (1 mm incisal or occlusal to gingival margin), and the adaptation will be verified on the casts. The trays will be placed over teeth to verify the adaptation in the participants' mouths. | Other | Hydrogen peroxide 9.5% bleaching using a tray without reservoir. |
Primary outcome
Peroxide level in saliva
Time frame: T0: 1 min after beginning of the bleaching procedure and application of the tray
Peroxide concentration in saliva (mg/ml)
Peroxide level in saliva
Time frame: T1: 5 min after tray application
Peroxide concentration in saliva (mg/ml)
Peroxide level in saliva
Time frame: T2: 10 min after tray application
Peroxide concentration in saliva (mg/ml)
Peroxide level in saliva
Time frame: T3: 30 min after tray application
Peroxide concentration in saliva (mg/ml)
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 3 Jan 2025.
- Background: PubMed 25408594Alqahtani MQ. Tooth-bleaching procedures and their controversial effects: A literature review. Saudi Dent J. 2014 Apr;26(2):33-46. doi: 10.1016/j.sdentj.2014.02.002. Epub 2014 Mar 12.
- Background: PubMed 15853099Auschill TM, Hellwig E, Schmidale S, Sculean A, Arweiler NB. Efficacy, side-effects and patients' acceptance of different bleaching techniques (OTC, in-office, at-home). Oper Dent. 2005 Mar-Apr;30(2):156-63.
- Background: PubMed 20166405Bernardon JK, Sartori N, Ballarin A, Perdigao J, Lopes GC, Baratieri LN. Clinical performance of vital bleaching techniques. Oper Dent. 2010 Jan-Feb;35(1):3-10. doi: 10.2341/09-008CR.
- Background: PubMed 12907697Dahl JE, Pallesen U. Tooth bleaching--a critical review of the biological aspects. Crit Rev Oral Biol Med. 2003;14(4):292-304. doi: 10.1177/154411130301400406.
- Background: PubMed 21221681Marques DN, da Mata AD, Silveira JM, Marques JR, Amaral JP, Guilherme NF. Hydrogen peroxide release kinetics into saliva from different whitening products: a double-blind, randomized clinical trial. Clin Oral Investig. 2012 Feb;16(1):155-63. doi: 10.1007/s00784-010-0491-x. Epub 2011 Jan 8.
- Background: PubMed 26162258Geisinger S, Kwon SR, Qian F. Employment of Reservoirs in At-Home Whitening Trays: Efficacy and Efficiency in Tooth Whitening. J Contemp Dent Pract. 2015 May 1;16(5):383-8. doi: 10.5005/jp-journals-10024-1694.
- Background: PubMed 19543926Goldberg M, Grootveld M, Lynch E. Undesirable and adverse effects of tooth-whitening products: a review. Clin Oral Investig. 2010 Feb;14(1):1-10. doi: 10.1007/s00784-009-0302-4. Epub 2009 Jun 20.
- Background: PubMed 12828984Hannig C, Zech R, Henze E, Dorr-Tolui R, Attin T. Determination of peroxides in saliva--kinetics of peroxide release into saliva during home-bleaching with Whitestrips and Vivastyle. Arch Oral Biol. 2003 Aug;48(8):559-66. doi: 10.1016/s0003-9969(03)00102-x.
- Background: PubMed 15810475Hannig C, Zech R, Henze E, Dreier S, Attin T. Peroxide release into saliva from five different home bleaching systems in vivo. Am J Dent. 2005 Feb;18(1):13-8.
- Background: PubMed 16774513Hannig C, Willenbucher S, Becker K, Mahony C, Attin T. Recovery of peroxides in saliva during home bleaching--influence of smoking. J Oral Rehabil. 2006 Jul;33(7):533-41. doi: 10.1111/j.1365-2842.2005.01579.x.
- Background: PubMed 1410249Haywood VB. History, safety, and effectiveness of current bleaching techniques and applications of the nightguard vital bleaching technique. Quintessence Int. 1992 Jul;23(7):471-88.
- Background: PubMed 7930184Haywood VB, Leonard RH, Nelson CF, Brunson WD. Effectiveness, side effects and long-term status of nightguard vital bleaching. J Am Dent Assoc. 1994 Sep;125(9):1219-26. doi: 10.14219/jada.archive.1994.0154.
Related trials for Consumption
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Recruiting
Nutrition Outcomes Using a Randomized Intervention Via Smartphone on Dietary Habits
Healthy Adult Participants, Mindful Eating Intervention
RecruitingObservational study
Impact of Mediterranean Diet and Processed Food Consumption on Gastrointestinal Symptoms in Coeliac Patients on a Gluten-Free Diet
Celiac Disease, Gluten-free Diet
Recruiting
Effects of a Hemp Seed-based Product on Appetite and Health Parameters
Healthy
Recruiting
Effects of Dietary Supplements on Muscle Mass and Function While Using GLP-1 Medication
Obesity & Overweight, Muscle Mass and Strength
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 9.5% hydrogen peroxide bleaching (POLA DAY advanced tooth whitening system, SDI) using a tray with reservoir and 9.5% hydrogen peroxide bleaching (POLA DAY advanced tooth whitening system, SDI) using a tray without reservoir. in people with Consumption and Toxicity, run by Cairo 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 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: finished, as of the sponsor's last update on 3 Jan 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?
Peroxide level in saliva (time frame: T0: 1 min after beginning of the bleaching procedure and application of the tray). 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?
On the ClinicalTrials.gov record for NCT05605834, which also lists 26 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 3 Jan 2025.