Efficacy of an Amine and Zinc Lactate - Containing Mouthrinse in the Home-based Treatment of Plaque-induced Gingivitis in Adolescents.

NCT06671106 | Recruiting FDA Device

• 1 other identifier: 297-2024-Sper-AUSLFe
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate if the adjunctive use of an amine and zinc lactate - containing mouthrinse may give significant benefits in the home-based treatment of plaque-induced gingivitis in adolescents. The study is based on the following hypothesis: the periodontal conditions of participants affected by gingivitis will significantly benefit from the implementation of the self-performed plaque control regimen (consisting of manual toothbrush and amine and zinc lactate toothpaste) with an amine and zinc lactate - containing mouthrinse. The benefit is expected to become manifest in terms of impact on clinical periodontal parameters, ecology of the subgingival environment, patient-reported outcomes and oral-health-related quality of life. In other words, gingivitis participants implementing their self-performed oral hygiene with the investigated mouthrinse are expected to assume a closer profile (based on the outcomes listed above) to periodontally healthy subjects when compared to gingivitis participants not using the investigated mouthrinse. One hundred fifty participants (100 adolescents with gingivitis and 50 periodontally healthy adolescents) will be selected for the study. Gingivitis patients will be asked to participate in 5 observation intervals: screening visit, study baseline, and 3 follow-up visits (3 weeks, 3 months, 6 months), while periodontally healthy controls will conclude their participation in the study within the baseline visit. According to the randomization list, at baseline gingivitis patients will receive one of the following home-based oral hygiene regimen:

• test intervention (Gt group): manual toothbrush (meridol) and dental floss (meridol) associated with amine and zinc lactate - containing toothpaste (meridol Gum Protection) and amine and zinc lactate - containing mouthrinse (meridol Gum Protection);
• control intervention (Gc group): manual toothbrush (meridol) and dental floss (meridol) associated with amine and zinc lactate - containing toothpaste (meridol Gum Protection); All periodontally healthy subjects will be assigned control intervention. At baseline, both gingivitis patients and periodontally healthy subjects will undergo:
• assessment of clinical periodontal parameters;
• subgingival plaque sampling for microbiological analysis;
• assessment of patient-reported outcomes (including oral-health related quality of life) using dedicated questionnaires; Gingivitis subjects will repeat the assessments at 3-week, 3-month, and 6-month follow-up visit. The 6-month proportion of periodontally healthy participants in each gingivitis group (Gt and Gc) will be regarded as the primary outcome of the study. Changes in clinical parameters, subgingival microbial community profile, and scores related to patient-reported outcomes will be regarded as the secondary outcome measures.

Conditions

Gingivitis

Keywords

mouthrinse; plaque-induced gingivitis; adolescents; oral hygiene; amine lactate; zinc lactate; gingival inflammation; periodontal diseases

Outcome Measures

Primary Outcomes (1)

• 6-month proportion of periodontally healthy participants

  At 6 months, the proportion (range: 0%-100%) of cases of periodontal health (as diagnosed according to the case definition of the 2017 World Workshop) will be evaluated and compared between Gt and Gc groups.

  6 months

Secondary Outcomes (9)

• Gingival Index (GI)

  3 weeks, 3 months, 6 months

• Plaque score

  3 weeks, 3 months, 6 months

• Bleeding on probing (BoP)

  3 weeks, 3 months, 6 months

• Probing depth (PD)

  3 weeks, 3 months, 6 months

• Clinical attachment level (CAL)

  3 weeks, 3 months, 6 months

Study Arms (3)

Gingivitis - test intervention

EXPERIMENTAL

Gingivitis patients assigned to test intervention will use: manual toothbrush (meridol) and dental floss (meridol) associated with amine and zinc lactate - containing toothpaste (meridol Gum Protection) and amine and zinc lactate - containing mouthrinse (meridol Gum Protection)

Other: toothbrushing; Other: flossing; Device: Toothpaste Product; Device: Mouthrinse

Gingivitis - control intervention

ACTIVE COMPARATOR

Gingivitis patients assigned to control intervention will use: manual toothbrush (meridol) and dental floss (meridol) associated with amine and zinc lactate - containing toothpaste (meridol Gum Protection)

Other: toothbrushing; Other: flossing; Device: Toothpaste Product

Periodontal health - no treatment

OTHER

Periodontally healthy subjects will be compared for baseline assessments with gingivitis patients of the other two arms. However, periodontally subjects will conclude their participation in the study within the baseline visit after receiving devices and instructions related to the control intervention.

Other: toothbrushing; Other: flossing; Device: Toothpaste Product

Interventions

toothbrushing OTHER

manual toothbrush (meridol)

Gingivitis - control intervention; Gingivitis - test intervention; Periodontal health - no treatment

flossing OTHER

dental floss (meridol)

Gingivitis - control intervention; Gingivitis - test intervention; Periodontal health - no treatment

Toothpaste Product DEVICE

amine and zinc lactate - containing toothpaste (meridol Gum Protection)

Gingivitis - control intervention; Gingivitis - test intervention; Periodontal health - no treatment

Mouthrinse DEVICE

amine and zinc lactate - containing mouthrinse (meridol Gum Protection)

Gingivitis - test intervention

Eligibility Criteria

• Age: 12 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• systemically healthy;
• eligible for oral care provision by Regional Health Service due to low socio-economic status;
• at least 16 fully erupted teeth (excluding third molars);
• diagnosed with plaque-induced gingivitis (G) or periodontal health (PH) according to the World Workshop case definitions (Trombelli et al. 2018, Chapple et al. 2018);
• willing to participate in the study and capable to fully understand and comply with the study procedures (including questionnaire reading and filling).

You may not qualify if:

• pregnant or lactating;
• current smoking;
• motor and/or cognitive deficit impairing compliance with the study intervals or procedures;
• legal guardian not willing to either allow for subject participation in the study or ensure adherence with the study procedures;
• teeth with developmental defects (e.g., enamel pearls/projections);
• untreated oral lesions, including dental caries or endodontic lesions;
• fixed or removable orthodontic appliances or scheduled for orthodontic therapy with a timing not compatible with the experimental phase;
• use of antibiotics in the previous 3 months;
• use of medications that affect the size of the gingival tissues, such as phenytoin, sodium valproate, certain calcium channel-blocking drugs (e.g., nifedipine, verapamil, diltiazem, amlodipine, felodipine), and immune-regulating drugs (e.g., cyclosporine);
• conditions (e.g., Sjögren's syndrome, anxiety, poorly controlled diabetes) or medications (e.g., antihistamines, decongestants, antidepressants) that are associated with hyposalivation.

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead
• Consorzio Futuro in Ricerca: collaborator

Study Sites (1)

Operative Unit of Dentistry

Ferrara, 44121, Italy

RECRUITING

Related Publications (2)

• Montesani L, Montesani L, Mateo L, Daep C, Huber N, Isapour G, Zhang YP. Antibacterial and clinical effectiveness of a mouthwash with a novel active system of amine + zinc lactate + fluoride: a randomized controlled trial. Clin Oral Investig. 2024 Jan 13;28(1):90. doi: 10.1007/s00784-023-05487-0.

  PMID: 38217757 BACKGROUND

• Trombelli L, Farina R, Silva CO, Tatakis DN. Plaque-induced gingivitis: Case definition and diagnostic considerations. J Clin Periodontol. 2018 Jun;45 Suppl 20:S44-S67. doi: 10.1111/jcpe.12939.

  PMID: 29926492 BACKGROUND

MeSH Terms

Conditions

Gingivitis; Periodontal Diseases

Interventions

Toothbrushing

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oral Hygiene; Preventive Dentistry; Dentistry

Central Study Contacts

Leonardo Trombelli, Full Professor and Director

CONTACT

+390532688507; leonardo.trombelli@unife.it

Roberto Farina, Associate Professor

CONTACT

+390532688506; roberto.farina@unife.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Model Details: Single center, examiner-blind, parallel-arm, randomized trial

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: November 4, 2024
• Study Start: January 7, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)