Evaluation of the Whitening Effect in Subjects After Professional Tooth Cleaning Procedure

Evaluation of the Effect of a Cosmetic Product for Teeth Care in Maintaining the Whitening Effect of a Professional Dental Cleaning Performed by a Dentist - In Use Test Under Dentist Control Study

The goal of this study is to learn if the toothpaste works to maintain effect of the professional tooth cleaning in adults. It will also learn about the safety of the product. The main questions it aims to answer are:

• Does the toothpaste help to maintain teeth colour after professional cleaning?

Researchers will compare whitening toothpaste to a regular toothpaste to see if it works to maintain effects of professional teeth cleaning.

Participants will:

• Use assigned toothpaste daily for 4 weeks
• Visit the clinic on the established days during 4 weeks for check ups and evaluation

Study Overview

• Status: Not yet recruiting
• Conditions: Tooth Color
• Intervention / Treatment: Other: Whitening toothpaste; Other: Regular toothpaste

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eleonora Sparta; Phone Number: +39 378 3052587; Email: eleonora.sparta@complifegroup.com

Study Locations

• Spain
  • Catalonia
    • Badalona, Catalonia, Spain, 08917
      • Clinica Dental Rob
      • Contact: Eleonora Sparta; Phone Number: +39 378 3052587; Email: eleonora.sparta@complifegroup.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy 55 subjects
2. Subjects of caucasian ethnicity
3. Subjects aged between 18 and 65 years (extremes included)
4. Subjects clinically showing stains on teeth (due to smoking, tea, coffee, wine or other food that typically stain teeth)
5. Subjects having at least one natural teeth or central superior incisors (tooth 11 and 21) with color shade at the inclusion ≥12 and ≤30 according to R20 Bleaching shade guide
6. Subjects registered with National Health Service (NHS)
7. Subjects certifying the truthfulness of the personal data disclosed to the Principal Investigator or designated personnel
8. Subjects able to understand the language used in the investigation center and the information given by the Principal Investigator or designated personnel
9. Subjects able to respect the instructions given by the Principal Investigator or designated personnel as well as able to respect the study constraints and specific requirements
10. Subjects who commit not to change their daily routine or lifestyle during the study
11. Subjects on stable pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) for at least one month without any changes expected or planned during the study
12. Subjects informed about the test procedures who have signed a consent form and privacy agreement

Exclusion Criteria:

1. Subjects who do not meet the inclusion criteria.
2. Subjects with all affection which could interfere with the interpretation of the results of the study
3. Subjects planning toothcare during the study period, using dental apparatus
4. Subjects using dental prosthesis affecting the central superior incisors, with generalized tooth recession, malocclusion or overlapping teeth in the anterior region, with presence of caries, with dental abscess or untreated gum disease, with central superior incisor (tooth 11 or 21) evaluated and filled and who performed whitening treatments less than 6 months before the study begin
5. Subjects with any acute, chronic, or progressive disease or condition that may interfere with the study data or that the Principal Investigator considers dangerous to the subject or incompatible with the requirements of the study
6. Subjects participating or planning to participate in other clinical trials
7. Subjects who participated in a similar study without respecting an adequate washout period (at least one month)
8. Subjects that have intolerances or allergies to ingredients of the study product
9. Subjects under pharmacological treatments that are considered incompatible with the study requirement by the Principal Investigator
10. Subjects who are currently using products with the same activity as the study product, or who haven't observed an adequate washout period (at least one month)
11. Subjects admitted to a health or social facility
12. Subjects planning a hospitalization during the study
13. Subjects not able to be contacted in case of emergency
14. Subjects deprived of freedom by administrative or legal decision or under guardianship
15. Subjects who have or have had a history of alcohol or drug addiction
16. Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Whitening toothpaste; Whitening toothpaste will be used 3 times a day during 28 days after teeth cleaning procedure.	Other: Whitening toothpaste; Subjects will use the whitening toothpaste 3 times daily during 4 weeks
Active Comparator: Regular toothpaste; Regular toothpaste will be used 3 times a day during 28 days after teeth cleaning procedure.	Other: Regular toothpaste; Subjects will use the regular toothpaste 3 times daily during 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in teeth colour at by R20 Bleaching guide score at 4 weeks	The score ranges from 2 (lightest shade) to 40 (darkest shade). Improvement in colour means decrease in score number.	From Baseline (after professional teeth cleaning) to end of use at 4 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Teeth brightness variation evaluated by score at 4 weeks	The brightness will be evaluated by the score from 1 to 4, where 1 means no variation and 4 means evidant improvement	From Baseline (after professional teeth cleaning) to end of use at 4 weeks.

Collaborators and Investigators

• Sponsor: Lacer S.A.
• Investigators: Principal Investigator: Sonia Robas, Dr, Clinica Dental Rob

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: February 18, 2026
• First Submitted That Met QC Criteria: February 24, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: hydrated silica gel-based toothpaste
• Other Study ID Numbers: PIT0000327/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only summary of the results to support the publication will be shared. No complete study documents will shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No