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Completed

NCT Number: NCT05021965

The Effectiveness of At-home , In-office and Combined Dental Bleaching System :A Randomized Controlled Clinical Trial

This randomized controlled clinical trial aimed to investigate the effectiveness of at-home , in-office and combined dental bleaching system.

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Key information

Conditions

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fujian Medical University

Fuzhou, Fujian, 350004, China

About this study

The participants with at least one maxillary tooth demonstrating shade A3 or darker will be recruited and randomly allocated into 4 groups according to the different tooth bleaching protocol:at-home bleaching for group 1,in-office bleaching for group 2 ,combined bleaching for group 3 and group 4.Participates in group 1 will receive two weeks of at-home tooth bleaching (Lasts 14 days and at least 8 hours every day )with 10% Carbamide peroxide(Opalescence PF 10%) , group 2 will receive two sessions (with a 1- week interval )of in-office tooth bleaching with 40% hydrogen peroxide (Opalescence Boost PF 40%),group 3 will receive one week of at-home tooth bleaching (Lasts 7 days and at least 8 hours every day )and then the eighth day receive one session of in-office tooth bleaching , group 4 receive one session of in-office bleaching and lasts 7 days at-home bleaching start on the eighth day . Colour parameters (CIE L*, a*, b*) will be measured with a spectrophotometer (Vita Easyshade Advance 4.0) at baseline (T1), after the first bleaching session (T2), after the second bleaching session (T3), 1 month after the completion of bleaching (T4). CIEDE2000 colour difference (△E00), the Whiteness Index for Dentistry (WID) and Tooth sensitivity (TS) will also be calculated. The data will be statistically analysed through repeated ANOVA and Tukey's test (α = 0.05).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • patients between 18 and 30 years of age, with fully erupted upper and lower incisors and canines without dental or periodontal disease or restorations, and with at least one maxillary tooth presenting color score A3 or darker, as measured with the Vita Classical guide (Vita Zahnfabrik, Bad Sa # ckingen, Germany) ordered by brightness

Exclusion criteria

  • patients with systemic diseases or oral mucosal disorders, previous bleaching treatment, patients undergoing orthodontic treatment, pregnant or lactating women , people with known allergy to the product ingredients, smokers, and alcohol abusers, had severe internal tooth discoloration (e.g. tetracycline stains), had bruxism or any other pathology that could cause TS (such as gingival recession or dentin exposure).

Treatment and study plan

different combined of tooth bleaching procedure

Procedure

The participants will be randomly allocated into 4 groups and receive different kind of tooth bleaching protocol.

Primary outcomes

  1. Change in tooth colour

    Time frame: six weeks

    Colour parameters (CIE L*, a*, b*) will be measured with a spectrophotometer (Vita Easyshade Advance 4.0). The color alteration after each session will be given by the differences between the values obtained at the sessions and the baseline (∆E).

Secondary outcomes

  1. Tooth sensitivity evaluation

    Time frame: two weeks

    Using the visual analogue scale (VAS) record the Tooth sensitivity (TS) throughout the entire treatment

Sponsors and collaborators

Lead sponsor

Fujian Medical University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 26, 2021
Registry last updated
Sep 29, 2023

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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