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RecruitingNCT06224699Updated Jan 25, 2024

Toothpaste With Sodium Carbonate in Patients With Gingivitis

An interventional study of Toothpaste Product in Gingivitis and Periodontal Diseases, sponsored by University of Catania. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-25.

Sponsored by University of Catania · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2024, 2 years 7 months ago, but the record still lists the study as recruiting.
  • Registered 4 months after the study started (first participant enrolled Sep 2023, registered Jan 2024).
  • Started Sep 2023; still recruiting 3 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Gingivitis
  • Periodontal Diseases
03

In context

Gingivitis

590 studies on the registry are indexed under Gingivitis; 105 are open to participants now.

This study's planned enrollment of 44 is below the median of 64 across 478 interventional studies indexed under Gingivitis.

Browse Gingivitis studies →

Lead sponsor

University of Catania is the lead sponsor of 68 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Periodontal treatment, antibiotics, NSAIDs, immunosuppressants during the last 6 months.
  • Pregnancy.
  • Systemic diseases.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
44 participants (estimated)

Study arms

  • Experimental
    Test group

    Use of toothpaste with sodium carbonate 67%

    Drug: Toothpaste Product

  • Placebo comparator
    Control

    Use of toothpaste without sodium carbonate 67%

    Drug: Toothpaste Product

Interventions

  • DrugToothpaste Product

    Use of toothpaste with or without sodium carbonate at 67%

06

What researchers measure

Primary outcomes

  1. Gingival index (1-4)

    Gingival index reduction

    Time frame: 6-months

07

Study locations

1 of 1 sites recruiting
  • AOU Policlinico Catania
    Catania, 95124, Italy
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Study results

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06224699
Lead sponsor
University of Catania
Responsible party
Gaetano Isola (Associate Professor, University of Catania) — Principal investigator
First posted
Jan 25, 2024
Start date
Sep 1, 2023
Primary completion
Mar 1, 2024 (estimated)
Completion
Mar 1, 2024 (estimated)
Last update
Jan 25, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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