Assessment of Peroxide Level in Saliva During Teeth Bleaching With 9.5% Hydrogen Peroxide Gel

Toxicity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05605834
• Other study ID #: a tray with reservoir
• Status: Completed
• Phase: N/A
• Start date: January 10, 2023
• Est. completion date: May 8, 2024

Study information

• Verified date: May 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 8, 2024
• Est. primary completion date: February 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• participants:

1. Good general health.

2. Adult patients aged 18-40 years.

3. Absence of non-carious cervical lesions, active caries, gingival recession, or periodontal disease.

4. Do not use orthodontics appliance or removable prosthesis.

teeth:

1. Maxillary anterior teeth without caries, restorations and/or endodontic treatment.

2. Mild generalized staining.

Exclusion Criteria:

• participants:

1. Smoking or alcohol dependent patients.

2. Pregnancy and lactating women.

3. Parafunctional habits or pathologies.

4. Periapical alterations.

5. Use of medicaments that alter salivary flow.

6. Patients who had already undergone tooth bleaching

7. Patients with severe internal tooth discoloration as tetracycline stain, fluorosis or endodontic treatment.

teeth:

1. Tooth hypersensitivity.

2. Presence of cracks or fractures.

3. Periodontal affection sign and symptoms.

Related Conditions & MeSH terms

• Consumption
• Toxicity

Intervention

Other:
• 9.5% hydrogen peroxide bleaching (POLA DAY advanced tooth whitening system, SDI) using a tray with reservoir
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.
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.

Locations

Country	Name	City	State
Egypt	Faculty of dentistry	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (26)

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peroxide level in saliva	Peroxide concentration in saliva (mg/ml)	T0: 1 min after beginning of the bleaching procedure and application of the tray
Primary	Peroxide level in saliva	Peroxide concentration in saliva (mg/ml)	T1: 5 min after tray application
Primary	Peroxide level in saliva	Peroxide concentration in saliva (mg/ml)	T2: 10 min after tray application
Primary	Peroxide level in saliva	Peroxide concentration in saliva (mg/ml)	T3: 30 min after tray application