Toothpaste With Sodium Carbonate in Patients With Gingivitis

NCT ID: NCT06224699

Last Updated: 2024-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-03-01

Brief Summary

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Sodium carbonate has several properties that may be beneficial in the management of bacterial biofilm in gingivitis patients. The aim of this RCT study is to clinically evaluate the clinical properties of two toothpaste containing Sodium carbonate 67% and fluoride toothpaste that contains no bicarbonate on patients with gengivitis.

Detailed Description

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Sodium carbonate has several properties that may be beneficial in the management of bacterial biofilm in both gingivitis and periodontitis patients. The aim of this RCT study is to clinically evaluate the clinical properties of two toothpaste containing sodium carbonate at 67% or no sodium carbonate at 67% at 6-month follow-up in patients with gingivits. The study was designed as a double-blind randomized controlled trial (RCT) with 2 parallel groups of individuals.

Conditions

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Gingivitis Periodontal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study was designed as a double-blind randomized controlled trial (RCT) with 2 parallel groups of individuals with gingivitis
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Sealed envelopes

Study Groups

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Test group

Use of toothpaste with sodium carbonate 67%

Group Type EXPERIMENTAL

Toothpaste Product

Intervention Type DRUG

Use of toothpaste with or without sodium carbonate at 67%

Control

Use of toothpaste without sodium carbonate 67%

Group Type PLACEBO_COMPARATOR

Toothpaste Product

Intervention Type DRUG

Use of toothpaste with or without sodium carbonate at 67%

Interventions

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Toothpaste Product

Use of toothpaste with or without sodium carbonate at 67%

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinically diagnosed with gingivitis according to the EFP/AAP 2017 criteria.

Exclusion Criteria

* Periodontal treatment, antibiotics, NSAIDs, immunosuppressants during the last 6 months.
* Pregnancy.
* Systemic diseases.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Catania

OTHER

Sponsor Role lead

Responsible Party

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Gaetano Isola

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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AOU Policlinico Catania

Catania, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Rosalia Leonardi, DDS

Role: primary

+0953782629

Other Identifiers

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149/22/PO

Identifier Type: -

Identifier Source: org_study_id

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