NCT06700434

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

Clinical Evaluation of In-office Bleaching With Low, Medium, and High Concentrate Hydrogen Peroxide: A 6-month a Double-blinded Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Gazi University · Academic / Other
• Sex: All
• Age: 21 Years – 28 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-09-11
• Primary completion: 2023-10-15
• Completion: 2024-03-15
• First posted: 2024-11-22
• Last updated: 2024-11-22

Locations

1 site across 1 country: Turkey (Türkiye)