ConsumptionNCT05612516
Peroxide Level in Saliva During Teeth Bleaching Using a Tray With Reservoir Versus a Tray Without Reservoir.
A study testing Assessment of hydrogen peroxide levels in saliva using trays with reservoir. and Assessment of hydrogen peroxide levels in saliva using trays without reservoir. in people with Consumption, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the study is to clinically assess the peroxide levels in saliva during bleaching with 9.5% hydrogen peroxide using a tray with or without reservoir. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Consumption
- What is being tested?
- Assessment of hydrogen peroxide levels in saliva using trays with reservoir. and Assessment of hydrogen peroxide levels in saliva using trays without reservoir.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2024to 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
- Good general health.
- Absence of non-carious cervical lesions, active caries, gingival recession, or periodontal disease.
- Do not use orthodontics appliance or removable prosthesis.
- Maxillary anterior teeth without caries, restorations and/or endodontic treatment.
- Mild generalized staining.
Who cannot join
- Smoking or alcohol dependent patients.
- Pregnancy and lactating women.
- Parafunctional habits or pathologies.
- Periapical alterations.
- Use of medicaments that alter salivary flow.
- Patients who had already undergone tooth bleaching
Show all 10Show fewer
- Patients with severe internal tooth discoloration as tetracycline stain, fluorosis or endodontic treatment.
- 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
The aim of the study is to clinically assess the peroxide levels in saliva during bleaching with 9.5% hydrogen peroxide using a tray with or without reservoir.
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. (Alqahtani, 2014). Several researches have focused on the problem of gel ingestion and potential peroxide release in saliva (Dahl et al, 2003; Watt et al, 2004; Bernardon et al, 2010; Goldberg et al, 2010).
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. Martini et al, 2020 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 (Javaheri et al, 2000). 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. (Haywood et al, 1992).
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 (IGHRC, 2003; Hannig et al, 2005; Li et al, 2011). The safety of hydrogen peroxide products used for at home bleaching regarding peroxide release in saliva has not been fully proven.
- Conditions
- Consumption
- Being tested
- Assessment of hydrogen peroxide levels in saliva using trays with reservoir., Assessment of hydrogen peroxide levels in saliva using trays without reservoir.
- Keywords
- Home bleaching, Tray with reservoir, Tray without reservoir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of hydrogen peroxide levels in saliva using trays with reservoir.Procedure or surgery
During bleaching using trays with reservoir.
Assessment of hydrogen peroxide levels in saliva using trays without reservoir.Procedure or surgery
During bleaching using trays without reservoir.
| Study group | Role | What they receive |
|---|---|---|
| Hydrogen peroxide 9.5% bleaching using a tray with reservoir. | Active comparator | . Alginate impressions of maxillary dental arches of patients will be taken to obtain casts and produce the customized trays.
Reservoirs 1.5 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 1.5 mm-thick vinyl acetate sheets using the thermoforming process. Trays will be precisely trimmed completely involving tooth surface (1.5 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. Receives: Procedure: Assessment of hydrogen peroxide levels in saliva using trays with reservoir. |
| Hydrogen peroxide 9.5% bleaching using a tray without reservoir. | Active comparator | 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. Receives: Procedure: Assessment of hydrogen peroxide levels in saliva using trays without reservoir. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hydrogen peroxide level in saliva
A spectrophotometry method based on the reaction of 4-aminoantipyrine and phenol with hydrogen peroxide will be adopted. This method will allow the oxidation of peroxide by peroxidase enzyme, resulting in solution color change from transparent to pink. The amount of hydrogen peroxide in saliva will be quantified by an analytic spectrophotometer, which will relate light absorbance with peroxide concentration of each sample.
Measured: 1 min after beginning of the bleaching procedure and application of the tray.
Hydrogen peroxide level in saliva
A spectrophotometry method based on the reaction of 4-aminoantipyrine and phenol with hydrogen peroxide will be adopted. This method will allow the oxidation of peroxide by peroxidase enzyme, resulting in solution color change from transparent to pink. The amount of hydrogen peroxide in saliva will be quantified by an analytic spectrophotometer, which will relate light absorbance with peroxide concentration of each sample.
Measured: 5 min after tray application
Hydrogen peroxide level in saliva
A spectrophotometry method based on the reaction of 4-aminoantipyrine and phenol with hydrogen peroxide will be adopted. This method will allow the oxidation of peroxide by peroxidase enzyme, resulting in solution color change from transparent to pink. The amount of hydrogen peroxide in saliva will be quantified by an analytic spectrophotometer, which will relate light absorbance with peroxide concentration of each sample.
Measured: T2: 10 min after tray application
Hydrogen peroxide level in saliva
A spectrophotometry method based on the reaction of 4-aminoantipyrine and phenol with hydrogen peroxide will be adopted. This method will allow the oxidation of peroxide by peroxidase enzyme, resulting in solution color change from transparent to pink. The amount of hydrogen peroxide in saliva will be quantified by an analytic spectrophotometer, which will relate light absorbance with peroxide concentration of each sample.
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 posted10 Nov 2022
- Study start10 Jan 2024
- 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.
- 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
- Single blind
- Who is masked
- 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 I ElSayad, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612516
- Sponsor's protocol ID
- CU-2-2022
- Status last verified
- May 2024
- First submitted
- 3 Nov 2022
- Last updated
- 14 May 2024
- 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 14 May 2024. 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
- NCT05612516
- Acronym / sponsor ID
- CU-2-2022
- Conditions
- Consumption
- Keywords
- Home bleaching, Tray with reservoir, Tray without reservoir
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 8 May 2024 (actual)
- First posted
- 10 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.
The aim of the study is to clinically assess the peroxide levels in saliva during bleaching with 9.5% hydrogen peroxide using a tray with or without reservoir.
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. (Alqahtani, 2014). Several researches have focused on the problem of gel ingestion and potential peroxide release in saliva (Dahl et al, 2003; Watt et al, 2004; Bernardon et al, 2010; Goldberg et al, 2010).
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. Martini et al, 2020 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 (Javaheri et al, 2000). 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. (Haywood et al, 1992).
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 (IGHRC, 2003; Hannig et al, 2005; Li et al, 2011). 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
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrogen peroxide 9.5% bleaching using a tray with reservoir. | Active comparator | Procedure: Assessment of hydrogen peroxide levels in saliva using trays with reservoir.. Alginate impressions of maxillary dental arches of patients will be taken to obtain casts and produce the customized trays. Reservoirs 1.5 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 1.5 mm-thick vinyl acetate sheets using the thermoforming process. Trays will be precisely trimmed completely involving tooth surface (1.5 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. |
| Hydrogen peroxide 9.5% bleaching using a tray without reservoir. | Active comparator | Procedure: Assessment of hydrogen peroxide levels in saliva using trays 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Good general health.
- Absence of non-carious cervical lesions, active caries, gingival recession, or periodontal disease.
- Do not use orthodontics appliance or removable prosthesis.
- Maxillary anterior teeth without caries, restorations and/or endodontic treatment.
- Mild generalized staining.
Key exclusion criteria (10 listed)
- Smoking or alcohol dependent patients.
- Pregnancy and lactating women.
- Parafunctional habits or pathologies.
- Periapical alterations.
- Use of medicaments that alter salivary flow.
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 |
|---|---|---|
| Assessment of hydrogen peroxide levels in saliva using trays with reservoir.During bleaching using trays with reservoir. | Procedure or surgery | Hydrogen peroxide 9.5% bleaching using a tray with reservoir. |
| Assessment of hydrogen peroxide levels in saliva using trays without reservoir.During bleaching using trays without reservoir. | Procedure or surgery | Hydrogen peroxide 9.5% bleaching using a tray without reservoir. |
Primary outcome
Hydrogen peroxide level in saliva
Time frame: 1 min after beginning of the bleaching procedure and application of the tray.
A spectrophotometry method based on the reaction of 4-aminoantipyrine and phenol with hydrogen peroxide will be adopted. This method will allow the oxidation of peroxide by peroxidase enzyme, resulting in solution color change from transparent to pink. The amount of hydrogen peroxide in saliva will be quantified by an analytic spectrophotometer, which will relate light absorbance with peroxide concentration of each sample.
Hydrogen peroxide level in saliva
Time frame: 5 min after tray application
A spectrophotometry method based on the reaction of 4-aminoantipyrine and phenol with hydrogen peroxide will be adopted. This method will allow the oxidation of peroxide by peroxidase enzyme, resulting in solution color change from transparent to pink. The amount of hydrogen peroxide in saliva will be quantified by an analytic spectrophotometer, which will relate light absorbance with peroxide concentration of each sample.
Hydrogen peroxide level in saliva
Time frame: T2: 10 min after tray application
A spectrophotometry method based on the reaction of 4-aminoantipyrine and phenol with hydrogen peroxide will be adopted. This method will allow the oxidation of peroxide by peroxidase enzyme, resulting in solution color change from transparent to pink. The amount of hydrogen peroxide in saliva will be quantified by an analytic spectrophotometer, which will relate light absorbance with peroxide concentration of each sample.
Hydrogen peroxide level in saliva
Time frame: T3: 30 min after tray application
A spectrophotometry method based on the reaction of 4-aminoantipyrine and phenol with hydrogen peroxide will be adopted. This method will allow the oxidation of peroxide by peroxidase enzyme, resulting in solution color change from transparent to pink. The amount of hydrogen peroxide in saliva will be quantified by an analytic spectrophotometer, which will relate light absorbance with peroxide concentration of each sample.
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 14 May 2024.
- 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 I ElSayad, Professor 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 Assessment of hydrogen peroxide levels in saliva using trays with reservoir. and Assessment of hydrogen peroxide levels in saliva using trays without reservoir. in people with Consumption, 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 5 inclusion and 10 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 14 May 2024. 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?
Hydrogen peroxide level in saliva (time frame: 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?
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 14 May 2024.