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

NCT06700434 | Completed

• 1 other identifier: TGA-2023-8355
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hydrogen Peroxide; In-office bleaching; Randomized clinical trial; Tooth sensitivity; Whitening effectiveness; Quality of life

Outcome Measures

Primary Outcomes (1)

• Tooth Shade evaluation

  Tooth color was objectively evaluated using VitaTM Easy Shade V spectrophotometer (VITA Zanhnfabrik, BadSckingrn, Germany). The assesment was performed with daylight (10 a.m.to 2 p.m.) considering a 6 mm area situated in the middle section of the labial surface of the upper central incisors. In order to ensure consistency, alginate impressions were taken of the upper dental arches of each participant and stone molds were created. The custom trays were fabricated by using a 2mm Essix plate (Essix C; Dentsply, FL, USA) in a vacuum press machine (Ministar, Scheu, Iserlohn, Nordrhein-Westfalen Germany). 6 mm wide holes were drilled in the middle third of the buccal face of the central incisors on this trays to serve as a guide for using Easyshade V.

  baseline, immediately after the first bleaching session, immediately after the second whitening session (7 days after the first bleaching), 180 days after the first bleaching session

Secondary Outcomes (1)

• Tooth sensitivity evaluation

  baseline, immediately after the first bleaching session, two hours later, and 7 days later.

Other Outcomes (1)

• Impact of oral condition on quality of life

  baseline and 180 days after bleaching

Study Arms (3)

HP18

ACTIVE COMPARATOR

Bleaching agent containing Hydrogen Peroxide 18% and nano- hydroxyapatite

Other: Bleaching treatment

HP25

ACTIVE COMPARATOR

Bleaching agent containing Hydrogen Peroxide 20% and nano- hydroxyapatite

Other: Bleaching treatment

HP40

ACTIVE COMPARATOR

Bleaching agent containing Hydrogen Peroxide 40% and nano- hydroxyapatite

Other: Bleaching treatment

Interventions

Bleaching treatment OTHER

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.

HP18; HP25; HP40

Eligibility Criteria

• Age: 21 Years - 28 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women and men (at least 18 years old)
• 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)

You may not qualify if:

• Having undergone teeth bleaching procedure in the last 2 years,
• 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.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 40259078 DERIVED

MeSH Terms

Conditions

Tooth Discoloration; Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Associate Prof

  Gazi University

  STUDY DIRECTOR

• Research assistant

  Gazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Inclusion criteria: Females and males (least 18 years old), good oral and general health, no periodontal disease, no caries, and teeth colored A3 or darker according to the VITA Easy Shade Guide (VITA Zanhnfabrik, BadSckingrn, Germany).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A 6-month a double-blinded randomized controlled trial

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 22, 2024
• Study Start: September 11, 2023
• Primary Completion: October 15, 2023
• Study Completion: March 15, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)