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

NCT05605834 | Completed

• 1 other identifier: a tray with reservoir
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Consumption; Toxicity

Keywords

hydrogen peroxide; reservoir; peroxide level; saliva; assessment; non reservoir

Outcome Measures

Primary Outcomes (4)

• Peroxide level in saliva

  Peroxide concentration in saliva (mg/ml)

  T0: 1 min after beginning of the bleaching procedure and application of the tray

• Peroxide level in saliva

  Peroxide concentration in saliva (mg/ml)

  T1: 5 min after tray application

• Peroxide level in saliva

  Peroxide concentration in saliva (mg/ml)

  T2: 10 min after tray application

• Peroxide level in saliva

  Peroxide concentration in saliva (mg/ml)

  T3: 30 min after tray application

Study Arms (2)

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.

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.

Other: 9.5% hydrogen peroxide bleaching (POLA DAY advanced tooth whitening system, SDI) using a tray without reservoir.

Interventions

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

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.

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. 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.

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:

• 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.

You may not qualify if:

• participants:
• 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.
• teeth:
• 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

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Study Officials

• Iman Ibrahim El Sayad, prof

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: bachelor

Study Record Dates

• First Submitted: October 29, 2022
• First Posted: November 4, 2022
• Study Start: January 10, 2023
• Primary Completion: February 20, 2024
• Study Completion: May 8, 2024
• Last Updated: January 3, 2025

Record last verified: 2025-01

Locations

EG (1)