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

March 24, 2025 updated by: Leonardo Trombelli, Università degli Studi di Ferrara

Efficacy of an Amine and Zinc Lactate - Containing Mouthrinse in the Home-based Treatment of Plaque-induced Gingivitis in Adolescents. A Single-center, Examiner-blind, Parallel-arm, Randomized Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Ferrara, Italy, 44121
        • Recruiting
        • Operative Unit of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gingivitis - test intervention
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
manual toothbrush (meridol)
Other: flossing
dental floss (meridol)
Device: Toothpaste Product
amine and zinc lactate - containing toothpaste (meridol Gum Protection)
Device: Mouthrinse
amine and zinc lactate - containing mouthrinse (meridol Gum Protection)
Active Comparator: Gingivitis - control intervention
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
manual toothbrush (meridol)
Other: flossing
dental floss (meridol)
Device: Toothpaste Product
amine and zinc lactate - containing toothpaste (meridol Gum Protection)
Other: Periodontal health - no treatment
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
manual toothbrush (meridol)
Other: flossing
dental floss (meridol)
Device: Toothpaste Product
amine and zinc lactate - containing toothpaste (meridol Gum Protection)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-month proportion of periodontally healthy participants
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival Index (GI)
Time Frame: 3 weeks, 3 months, 6 months

GI (without the BoP component) will be assessed on a scale from 0 (no clinically detectable inflammation) to 3 (severe inflammation with spontaneous bleeding) at the mesio-buccal aspects of 6 index teeth (i.e., 1.6, 2.1, 2.4, 3.6, 4.1, 4.4).

Gt and Gc groups will be compared for the 3-week, 3-month and 6-month changes in Gi.
3 weeks, 3 months, 6 months
Plaque score
Time Frame: 3 weeks, 3 months, 6 months

Plaque score will be evaluated as present (0) or absent (1) at 6 sites (mesio-buccal, buccal, disto- buccal, mesio-lingual, lingual, disto-lingual) of each tooth.

Gt and Gc groups will be compared for the 3-week, 3-month and 6-month changes in the full-mouth proportion of sites with plaque.
3 weeks, 3 months, 6 months
Bleeding on probing (BoP)
Time Frame: 3 weeks, 3 months, 6 months

BoP will be evaluated as present/absent using a UNC15 probe (Hu-Friedy Italy s.r.l., Milano, Italy) at 6 sites (mesio-buccal, buccal, disto-buccal, mesio- lingual, lingual, disto-lingual) of each tooth.

Gt and Gc groups will be compared for the 3-week, 3-month and 6-month changes in the full-mouth prevalence of BoP (range: 0%-100%).
3 weeks, 3 months, 6 months
Probing depth (PD)
Time Frame: 3 weeks, 3 months, 6 months

PD will be measured in mm using a UNC15 probe (Hu-Friedy Italy s.r.l., Milano, Italy) at 6 sites (mesio-buccal, buccal, disto-buccal, mesio- lingual, lingual, disto-lingual) of each tooth.

Gt and Gc groups will be compared for the 3-week, 3-month and 6-month changes in PD.
3 weeks, 3 months, 6 months
Clinical attachment level (CAL)
Time Frame: 3 weeks, 3 months, 6 months

CAL will be measured in mm using a UNC15 probe (Hu-Friedy Italy s.r.l., Milano, Italy) at 6 sites (mesio-buccal, buccal, disto-buccal, mesio- lingual, lingual, disto-lingual) of each tooth.

Gt and Gc groups will be compared for the 3-week, 3-month and 6-month changes in CAL.
3 weeks, 3 months, 6 months
Plaque sampling and microbiological analysis
Time Frame: 3 weeks, 3 months, 6 months

Plaque sampling will be performed with sterile Mini Five Gracey curettes (Hu-Friedy Italy s.r.l., Milano, Italy) from the subgingival area at the mesio- buccal aspects of 6 index teeth (Manual of Procedures for Human Microbiome Project - Core Microbiome Sampling Protocol Version Number: 12.0; 29 Jul 2010).

The microbial composition of each sample will be analyzed by a real-time quantitative PCR (qPCR) microarray, providing profiling of microorganisms usually found in dental plaque (Microbial DNA qPCR Array for Oral Disease) (Qiagen, Hilden, Germany). Array assays are designed using the 16S rRNA gene as the target gene and individual primers and hydrolysis-probe detection, increasing specificity of each assay. Amplification will be carried out in a Quant Studio 5 thermocycler (Thermo Fisher Scientific, Milan, Italy), providing simultaneous detection and quantification of 93 different microbial species, including putative and known periodontopathogens.
3 weeks, 3 months, 6 months
Patient satisfaction with the use of the oral hygiene regimen
Time Frame: 6 months
At 6 months, the participant will be asked to state his/her degree of satisfaction with the use of the oral hygiene regimen used during the experimental phase. Satisfaction will be classified as follows: 0- excellent; 1-good; 2- acceptable; 3- poor. The participant will also be asked about possible side effects and complaints related to the use of the assigned products. This evaluation will be performed without the presence of the examiners to enable the participant to give his/her honest opinion.
6 months
Adverse events (AEs)
Time Frame: 6 months
Adverse events will be recorded on a dedicated form, and major adverse events will be immediately communicated to the Operative Unite of Legal Medicine, University - Hospital of Ferrara, Italy.
6 months
Oral-health related quality of life (OHrQoL)
Time Frame: Baseline, 6 months

At baseline and 6 months, participants will be instructed to fill the Child Perceptions Questionnaire for 11- to 14 year-old Children (CPQ11-14). The questionnaire will be filled by the participant under the supervision of the examiner.

The assessment is developed through 37 questions distributed in 4 sections, which refer to: oral symptoms, functional limitations, emotions related to the condition of the oral cavity, and what role this has in social relationships. Each question will be rated according to the following scale: never (0); once or twice (1); sometimes (2); often (3); every day or almost every day (4).

The total score will be obtained as the algebraic sum of the single scores, and will range from 0 (indicating no impact of the oral health condition on the quality of life) to 148 (indicating maximum impact of the oral condition on the quality of life).
Baseline, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi di Ferrara

Collaborators

Consorzio Futuro in Ricerca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

October 24, 2024

First Submitted That Met QC Criteria

October 31, 2024

First Posted (Actual)

November 4, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 297-2024-Sper-AUSLFe

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Biological samples (subgingival plaque) will be analyzed at the Section of Microbiology, University of Ferrara, Italy. However, the analysis will be conducted in a blinded fashion (no information related to patient identity and observation interval will be provided for each sample to be analyzed).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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