Clinical Efficacy of In-office Bleaching With Different Concentrations of Hydrogen Peroxide
NCT ID: NCT06700434
Last Updated: 2024-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2023-09-11
2024-03-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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HP18
Bleaching agent containing Hydrogen Peroxide 18% and nano- hydroxyapatite
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.
HP25
Bleaching agent containing Hydrogen Peroxide 20% and nano- hydroxyapatite
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.
HP40
Bleaching agent containing Hydrogen Peroxide 40% and nano- hydroxyapatite
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* People with good oral and general health
* People without periodontal disease
* Teeth without caries
* Teeth A3 or darker according to the VITA Easy Shade Guide (VITA Zanhnfabrik, BadSckingrn, Germany)
Exclusion Criteria
* People with tooth sensitivity,
* Use of fixed orthodontic appliances or prostheses on upper and/or lower anterior teeth,
* People with gingival recession,
* Discoloration due to parafunction, tetracycline or fluorosis,
* Smokers,
* Tooth fracture.
21 Years
28 Years
ALL
Yes
Sponsors
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Gazi University
OTHER
Responsible Party
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Hanife ALTINIŞIK
Associate Professor
Principal Investigators
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Associate Prof
Role: STUDY_DIRECTOR
Gazi University
Research assistant
Role: PRINCIPAL_INVESTIGATOR
Gazi University
Locations
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Gazi University
Ankara, , Turkey (Türkiye)
Countries
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References
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Altinisik H, Nezir M. Clinical evaluation of in-office bleaching with low, medium, and high concentrate hydrogen peroxide: a 6-month a double-blinded randomized controlled trial. Clin Oral Investig. 2025 Apr 21;29(5):260. doi: 10.1007/s00784-025-06348-8.
Other Identifiers
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TGA-2023-8355
Identifier Type: -
Identifier Source: org_study_id
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