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Clinical Efficacy of In-office Bleaching With Different Concentrations of Hydrogen Peroxide

NCT06700434 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-11-22

No results posted yet for this study

Summary

Objective: The study evaluated the longevity, effectiveness, sensitivity and impact on the oral health-related quality of life of in-office dental bleaching using low, medium, and high concentrate hydrogen peroxide.

Material and Methods: Randomized, parallel, and double-blinded clinical trial was performed with 54 participants using18% hydrogen peroxide (HP), 20%HP, and 40%HP in-office bleaching agent. Tooth color was evaluated at baseline, after the 1st session bleaching, after the 2st session bleaching and 6 months (T5) after finishing the bleaching using spectrophotometer. Tooth sensitivity was measured with the Visual Analog Scale at baseline, immediately after bleaching, after 1 day, and after 7 days. The impact on quality of life was evaluated using the Oral Health Impact Profile (OHIP) questionnaire at baseline, and 6 months after bleaching.

Conditions

  • Tooth Discoloration

Interventions

OTHER

Bleaching treatment

After the lip retractor (OptraGate, Ivoclar Vivadent, Schaan, Liechtenstein) was placed, the gingival barrier protection (Biowhiten, Biodent Ltd., İstanbul, Turkey) included in the products was applied to the upper and lower arches from premolar to premolar at the beginning of each session and removed after each treatment. The bleaching gels were applied according to the manufacturer and removed after the recommended period with a disposable surgical saliva ejector, cleaned with gauze and washed with air-water spray. Two bleaching sessions were performed at a 1-week interval. Participants were advised to maintain regular oral hygiene by brushing with toothpaste that does not contain desensitizing or whitening ingredients. HP18 is applied in 5 applications of 10 minutes per session. HP25 is applied in 3 applications of 15 minutes per session. HP40 is applied in 3 applications of 15 minutes per session.

Sponsors & Collaborators

  • Gazi University

    lead OTHER

Principal Investigators

  • Associate Prof · Gazi University

  • Research assistant · Gazi University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
28 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-11
Primary Completion
2023-10-15
Completion
2024-03-15

Countries

  • Turkey (Türkiye)

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 NCT06700434 on ClinicalTrials.gov