Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05021965
Enrollment
48
Registered
2021-08-26
Start date
2021-07-15
Completion date
2022-03-14
Last updated
2023-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth Bleaching

Brief summary

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

Detailed description

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).

Interventions

PROCEDUREdifferent combined of tooth bleaching procedure

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

Sponsors

Fujian Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Change in tooth coloursix weeksColour 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

MeasureTime frameDescription
Tooth sensitivity evaluationtwo weeksUsing the visual analogue scale (VAS) record the Tooth sensitivity (TS) throughout the entire treatment

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026