Study on the whitening and sensitive relief effects of LESENING Teeth Strips
| ISRCTN | ISRCTN30027746 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30027746 |
- Submission date
- 27/02/2025
- Registration date
- 07/03/2025
- Last edited
- 04/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
At-home tooth bleaching using low concentration peroxide has become a widely popular over-the-counter dental treatment. However, it is known to induce temporary dentin hypersensitivity following the whitening with peroxide. Potassium nitrate has been proven to effectively alleviate dentin hypersensitivity. The study objective was to evaluate the tooth whitening efficacy and tooth sensitivity of a novel whitening strips with 3% hydrogen peroxide and 1.5% potassium nitrate.
Who can participate?
Healthy participants, aged 18 to 60 years old, who were willing to whiten their teeth
What does the study involve?
Participants were randomly assigned into two groups: an experimental group using LESENING Whitening Strips with 3% hydrogen peroxide and 1.5% potassium nitrate, and the control group using Crest 3D Whitestrips only with 3% hydrogen peroxide. Tooth sensitivity was evaluated using scoring methods and tooth color and color change were assessed using laboratory methods, with assessments made at baseline and after 7, 14, 21, and 28 days of use.
What are the possible benefits and risks of participating?
Participants could receive tooth strips for free to make their teeth white and acquire dental aesthetics. During the trial process, experienced clinical doctors would provide diagnosis and treatment for all participants, closely monitoring changes in their oral hygiene status after enrollment. Due to the randomization and blinding, participants might undergo side effects of tooth-whitening such as dentin hypersensitivity or gingival ulcer. Clinicians would provide immediate safe treatments when these conditions happened.
Where is the study run from?
Affiliated Stomatological Hospital of Chongqing Medical University, China
When is the study starting and how long is it expected to run for?
May 2024 to August 2024
Who is funding the study?
1. Supported by Dencare Oral Care Co. Ltd., China
2. The Northern Department of Endodontics, Stomatological Hospital of Chongqing Medical University, China
Who is the main contact?
Prof Deqin Yang, 500246@hospital.cqmu.edu.cn
Contact information
Public, Scientific, Principal Investigator
Stomatological Hospital of Chongqing Medical University, No. 426, Songshi North Road, Yubei District
Chongqing
400000
China
 ORCID ID |
0009-0008-9333-4056 |
|---|---|
| Phone | +86 15185209090 |
| 1163686116@qq.com |
Scientific
Stomatological Hospital of Chongqing Medical University, No. 426, Songshi North Road, Yubei District
Chongqing
400000
China
| Phone | +86 023-88600060 |
|---|---|
| 500246@hospital.cqmu.edu.cn |
Study information
| Study design | Single-center interventional randomized double-blind clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home, Hospital |
| Study type | Safety, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Study on the whitening and sensitive relief effects of LESENING Teeth Strips containing 3% hydrogen peroxide and 1.5% potassium nitrate |
| Study objectives | The null hypothesis was that the LESENING Whitening Strips would have no effect on tooth color change and that there would be no difference in sensitivity between the LESENING and Crest strips. |
| Ethics approval(s) |
Approved 31/05/2024, The Ethics Committee at the Affiliated Stomatology Hospital of Chongqing Medical University (No. 426, Songshi North Road, Yubei District, Chongqing, 400000, China; +86 23 8860 2305; CYKQ_EC@163.com), ref: 202401 |
| Health condition(s) or problem(s) studied | Treatment for tooth discoloration and prevention of tooth hypersensitivity after tooth whitening. |
| Intervention | The trial was to compare the whitening efficacy and anti-sensitivity effects of LESENING Whitening Strips with that of Crest 3D Whitestrips. Following the initial examination, all participants signed informed consent forms and agreed to attend scheduled follow-up visits. They promised to use the designated non-fluoride toothpaste, not to use other whitening or anti-sensitivity toothpaste and desensitization drugs, and not to receive treatment that affected the color and sensitivity of the teeth during the study period. Participants were randomly assigned into two groups: an experimental group using LESENING Whitening Strips with 3% hydrogen peroxide and 1.5% potassium nitrate, and the control group using Crest 3D Whitestrips only with 3% hydrogen peroxide. The appearance of the two products was identical. Randomization was performed by an independent staff who was not involved in the study. The random number was generated by a random number table. 96 participants were randomly assigned to two groups by SPSS 27.0 software. Once participants were confirmed to be eligible and had completed baseline assessments, their enrollment numbers were recorded and input into software to determine the group assignment. Every participant's enrollment number and their group was printed and sealed in an envelope. During the process, participants brushed their teeth twice daily with the given non-fluoride toothpaste and used whitening strips once daily at night before brushing their teeth. First, participants cleaned their hands, tore off the protective cover, and took out the whitening strips. Second, the gel surface of the strip was attached to the buccal surface of teeth 13-23 and gently pressed until it adhered closely. The portion beyond the incisal edge was folded to the palatal surface of the tooth. After 30 minutes, the strips were removed, and teeth were brushed as usual. The change in tooth color measured by a spectrophotometer (ΔL*, Δa*, Δb*, ΔE*ab, and ΔWID) was the main result. The changes in tooth sensitivity and the safety assessment of any adverse reactions were the secondary results. Tooth color and sensitivity were measured at five time points: T0 (baseline, before use), T1 (7 days after starting whitening strips), T2 (14 days), T3 (21 days), and T4 (28 days). The maxillary central incisors, lateral incisors, and canines (13, 12, 11, 21, 22, 23; n=6) were measured three times, and the mean value (SDs) was used for data recording. All tooth color and sensitivity assessments during the period were performed by the same clinician. For each measurement, participants rinsed with water, and one clinician measured the color parameters of each tooth position. Sensitivity was assessed by another clinician, who recorded baseline data and provided the test products and instructions. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | LESENING Whitening Strips, Crest 3D Whitestrips |
| Primary outcome measure | The following primary outcome measures were assessed at T0 (baseline, before use), T1 (7 days after starting whitening strips), T2 (14 days), T3 (21 days), and T4 (28 days): 1. Tooth color measured using the Vita Easyshade V spectrophotometer: 1.1 CIELAB values (L, a, b) 1.2 ΔL (change in brightness) 1.3 Δa (change in red/green tone) 1.4 Δb (change in yellow/blue tone) 1.5 ΔEab (overall color change) 1.6 ΔWID (Dental Whitening Index) 2. Tooth sensitivity measured using the Schiff score (sensitivity score ranging from 0 to 3) |
| Secondary outcome measures | Subjective evaluation of tooth color was measured using two shade guides, the Vita Classical (VITA Zahnfabrik) and the Vita Bleachedguide 3D-MASTER (VITA Zahnfabrik) before and after whitening |
| Overall study start date | 28/05/2024 |
| Completion date | 23/08/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | 76 |
| Total final enrolment | 96 |
| Key inclusion criteria | 1. Healthy adults aged 18 to 60 2. Willingness to whiten teeth 3. No tetracycline staining 4. No fluorosis in natural maxillary anterior teeth 5. No external staining from smoking, plaque, or calculus 6. Untreated dentin hypersensitivity 7. Fixed orthodontic devices or removable partial dentures, fillings or crowns 8. Recent use of desensitizing products 9. Involvement in other similar trials |
| Key exclusion criteria | 1. Severe oral or systemic diseases 2. Allergy to the products 3. Ongoing periodontal disease in teeth 13-23 4. Periodontal treatment within the past year 5. Tooth mobility exceeding grade 1 6. Extensive restorations on the labial surfaces of teeth 13-23, pulpitis, caries, enamel cracks, smoking 7. Pregnancy or breastfeeding |
| Date of first enrolment | 08/06/2024 |
| Date of final enrolment | 28/07/2024 |
Locations
Countries of recruitment
- China
Study participating centre
Chongqing
400000
China
Sponsor information
Hospital/treatment centre
No. 426, Songshi North Road, Yubei District
Chongqing
400000
China
| Phone | +86-023-88602470 |
|---|---|
| CYKQ_GCP@163.com | |
| Website | https://english.cqmu.edu.cn/info/1190/1423.htm |
"ROR" |
https://ror.org/02bnr5073 |
Industry
No. 389, Haier Road, Jiangbei District
Chongqing
400000
China
| Phone | +86 13821073211 |
|---|---|
| zhangmin@dencare.com.cn |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/05/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Prof Deqin Yang, 500246@hospital.cqmu.edu.cn |
Editorial Notes
28/02/2025: Study's existence confirmed by the Clinical Trial Ethics Committee of Stomatological Hospital Affiliated to Chongqing Medical University.
