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Completed

NCT Number: NCT06700434

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

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.

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Key information

Age range

21 year–28 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Tooth Shade evaluation

    Time frame: 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

    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.

Secondary outcomes

  1. Tooth sensitivity evaluation

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

    To measure tooth sensitivity, participants indicated their discomfort level using a Visual Analog Scale (VAS).23 This scale is represented by a horizontal line measuring 10 centimeters in length. The endpoint of the line labeled "no pain" represents the absence of discomfort, while the opposite endpoint labeled "worst pain" represents the highest level of discomfort.

Other outcomes

  1. Impact of oral condition on quality of life

    Time frame: baseline and 180 days after bleaching

    The OHIP-14 questionnaire was utilized to evaluate the quality of life.24 This questionnaire consists of seven different domains and a total of 14 questions aimed at assessing one's quality of life. Responses to questions were determined by selecting one choice from a Likert scale. The scale included options like never (0 points), rarely (1 points), sometimes (2 points), often (3 points), and always (4 points), each corresponding to a certain number of points. A person's oral health-related quality of life (OHRQoL) is negatively affected when the average value of seven dimensions is higher.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Nov 22, 2024
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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