Tooth Discoloration, Tooth Staining
Conditions
Keywords
Bleaching, Color, Sensitivity, In-Office, Peroxide, Non-Peroxide
Brief summary
This randomized clinical trial aims to compare the effectiveness of peroxide and non-peroxide in-office tooth bleaching systems. The study will evaluate tooth whitening efficacy, color durability over time, and tooth sensitivity after treatment. Participants will receive one of the two bleaching treatments and will be followed for six months to assess the clinical outcomes and compare the performance of both systems.
Detailed description
This randomized controlled clinical trial is designed to compare the clinical performance of peroxide-based and non-peroxide in-office tooth bleaching systems. Eligible participants will be randomly allocated into two treatment groups. Tooth color will be assessed using standardized clinical evaluation methods before treatment, immediately after bleaching, and during follow-up visits. The study will also evaluate color stability and tooth sensitivity over a six-month follow-up period. The findings are expected to provide evidence regarding the effectiveness and safety of both bleaching systems and to support evidence-based clinical decision-making in esthetic dentistry.
Interventions
PROCEDUREperoxide -based in office tooth bleaching
Participants will receive an in-office peroxide-based tooth bleaching treatment using the bleaching system according to the manufacturer's instructions.
PROCEDUREnon-peroxide -based in office tooth bleaching
Participants will receive an in-office non- peroxide-based tooth bleaching treatment using the bleaching system according to the manufacturer's instructions.
Sponsors
Minia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Blinding of both the clinical operator and the patient is not possible because the bleaching materials will be used in the two groups differ in their clinical application. Therefore, the patients will recognize the difference between the two procedures, and the operator is also aware of the group allocation. However, the evaluators who responsible for bleaching index, color durability, tooth sensitivity assessment, as well as the statistician will be blinded to the group assignment to minimize bias and ensure objective outcome evaluation
Intervention model description
Participants will be randomly assigned to one of two parallel groups. One group will receive a peroxide-based in-office tooth bleaching treatment, and the other group will receive a non-peroxide in-office tooth bleaching treatment. Clinical outcomes will be evaluated and compared over a six-month follow-up period.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults aged 18-45 years. * Good general health. * Presence of all maxillary anterior teeth free from restorations, caries, or structural defects. * Baseline tooth shade suitable for bleaching assessment. * Good oral hygiene and periodontal health. * Willingness to comply with the study protocol and attend all follow-up visits. * Signed informed consent.
Exclusion criteria
* Pregnancy or lactation. * History of tooth hypersensitivity. * Active caries or defective restorations in the anterior teeth. * Intrinsic tooth discoloration (e.g., fluorosis, tetracycline staining). * Ongoing orthodontic treatment. * Smoking. * Use of tooth-whitening products within the previous 6 months. * Allergy to any component of the bleaching materials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bleaching efficacy measured by Whiteness Index for Dentistry (WID) | Baseline, immediately after treatment, 1 month, 3 months, and 6 months after treatment | Bleaching efficacy will be assessed using the Whiteness Index for Dentistry (WID) obtained by spectrophotometric measurements of the anterior teeth. |
| Color durability measured by CIEDE2000 color difference (ΔE00) | Baseline, immediately after treatment, 1 month, 3 months, and 6 months after treatment | Color durability will be evaluated using spectrophotometric color measurements and expressed as CIEDE2000 color difference (ΔE00). |
| Tooth sensitivity assessed using the Visual Analog Scale (VAS) | Daily during the 14-day treatment period | ooth sensitivity will be evaluated using a 0-10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst possible pain |
Countries
Egypt
Contacts
CONTACTEsraa Eid, MSc
Outcome results
None listed