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

NCT05605834 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-01-03

No results posted yet for this study

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

Interventions

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.

OTHER

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.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Iman Ibrahim El Sayad, prof · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-10
Primary Completion
2024-02-20
Completion
2024-05-08

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05605834 on ClinicalTrials.gov