Evaluation of the Effect of the Toothpaste on Delicate Gums

Lacer S.A.

Status: Enrolling

Conditions: Gingivitis

Treatments: Other: Gingivitis toothpaste; Other: Regular toothpaste

Study type: Interventional

Funder types: Industry

Identifiers

NCT07494747

EC_PIT0000334/25

Details and patient eligibility

About

The goal of this study is to learn if a toothpaste works to alleviate gingivitis in adults. It will also learn about the safety of the product. The main question it aims to answer is:

• Does the toothpaste help to improve signs of gingivitis? Researchers will compare gingivitis toothpaste to a regular toothpaste to see if it works to improve gingivitis.

Participants will:

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Healthy male and female subjects (with no specific repartition)

2. Subjects of Caucasian ethnicity

3. Subjects aged between 18 and 65 years (extremes included)

4. Subjects clinically showing moderate gums inflammation (gingivitis grade II, in particular all gingival scores for the mean should be between 1.75 and 2.3, according to Löe and Silness gingival scoring system), in particular:

   1. 40% of the subjects with localized gingivitis (10-30% of evaluated sites with bleeding)
   2. 60% of them with generalized gingivitis (>30% of evaluated sites with bleeding) Repartition to be respected in both study groups.

5. Subjects with dental plaque (total plaque score at inclusion ≥2)

6. Subjects registered with the national health service

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 centre 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. Smokers subjects
3. Subjects planning toothcare during the study period
4. Subjects using dental apparatus or using dental prosthesis, with generalized tooth recession, with presence of caries, with dental abscess or signs of periodontitis (periodontal probing depth >3mm) or active periodontitis
5. Subjects using other dental hygiene products than provided (e.g. dental floss, interdental brushes, mouthwash, etc) during the study period
6. 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
7. Subjects participating or planning to participate in other clinical trials
8. Subjects who participated in a similar study without respecting an adequate washout period (at least one month)
9. Subjects that have food intolerances or food allergies to ingredients of the study product
10. Subjects under pharmacological treatments that are considered incompatible with the study requirement by the Principal Investigator
11. Subjects who are currently using food supplement(s) and/or products with the same activity as the study product, or who haven't observed an adequate washout period (at least one month)
12. Subjects admitted to a health or social facility
13. Subjects planning a hospitalization during the study
14. Subjects not able to be contacted in case of emergency
15. Subjects deprived of freedom by administrative or legal decision or under guardianship
16. Subjects who have or have had a history of alcohol or drug addiction
17. Subjects with eating disorders (i.e. bulimia, psychogenic eating disorders, etc.)
18. Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

60 participants in 2 patient groups

Gingivitis tooothpaste

Experimental group

Treatment:

Other: Gingivitis toothpaste

Regular toothpaste

Active Comparator group

Treatment:

Other: Regular toothpaste