Peroxide Level in Saliva During Teeth Bleaching Using a Tray With Reservoir Versus a Tray Without Reservoir.

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.

Study Overview

• Status: Completed
• Conditions: Consumption
• Intervention / Treatment: Procedure: Assessment of hydrogen peroxide levels in saliva using trays with reservoir.; Procedure: Assessment of hydrogen peroxide levels in saliva using trays 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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 002
    • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 36 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Good general health.
2. Absence of non-carious cervical lesions, active caries, gingival recession, or periodontal disease.
3. Do not use orthodontics appliance or removable prosthesis.
4. Maxillary anterior teeth without caries, restorations and/or endodontic treatment.
5. Mild generalized staining.

Exclusion Criteria:

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.
8. Tooth hypersensitivity.
9. Presence of cracks or fractures.
10. Periodontal affection sign and symptoms.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hydrogen peroxide 9.5% bleaching using a tray 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.	Procedure: Assessment of hydrogen peroxide levels in saliva using trays with reservoir.; During bleaching using trays with reservoir.
Active Comparator: Hydrogen peroxide 9.5% bleaching 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.	Procedure: Assessment of hydrogen peroxide levels in saliva using trays without reservoir.; During bleaching using trays without reservoir.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	T3: 30 min after tray application

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Iman I ElSayad, Professor, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2024
• Primary Completion (Actual): February 20, 2024
• Study Completion (Actual): May 8, 2024

Study Registration Dates

• First Submitted: November 3, 2022
• First Submitted That Met QC Criteria: November 9, 2022
• First Posted (Actual): November 10, 2022

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Home bleaching; Tray with reservoir; Tray without reservoir
• Additional Relevant MeSH Terms: Anti-Infective Agents, Local; Anti-Infective Agents; Hydrogen Peroxide
• Other Study ID Numbers: CU-2-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No