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

NCT05612516 | Completed

• 1 other identifier: CU-2-2022
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Consumption

Keywords

Home bleaching; Tray with reservoir; Tray without reservoir

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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.

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.

Procedure: Assessment of hydrogen peroxide levels in saliva using trays without reservoir.

Interventions

Assessment of hydrogen peroxide levels in saliva using trays with reservoir. PROCEDURE

During bleaching using trays with reservoir.

Hydrogen peroxide 9.5% bleaching using a tray with reservoir.

Assessment of hydrogen peroxide levels in saliva using trays without reservoir. PROCEDURE

During bleaching using trays without reservoir.

Hydrogen peroxide 9.5% bleaching using a tray without reservoir.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of dentistry

Cairo, 002, Egypt

Location

Study Officials

• Iman I ElSayad, Professor

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master Degree student- Faculty of Dentistry

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 10, 2022
• Study Start: January 10, 2024
• Primary Completion: February 20, 2024
• Study Completion: May 8, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)