NCT06224699

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

January 25, 2024

Status Verified

January 1, 2024

Enrollment Period

6 months

First QC Date

January 16, 2024

Last Update Submit

January 16, 2024

Conditions

GingivitisPeriodontal Diseases

Outcome Measures

Primary Outcomes (1)

  • Gingival index (1-4)

    Gingival index reduction

    6-months

Study Arms (2)

Test group

EXPERIMENTAL

Use of toothpaste with sodium carbonate 67%

Drug: Toothpaste Product

Control

PLACEBO COMPARATOR

Use of toothpaste without sodium carbonate 67%

Drug: Toothpaste Product

Interventions

Toothpaste ProductDRUG

Use of toothpaste with or without sodium carbonate at 67%

ControlTest group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOU Policlinico Catania

Catania, 95124, Italy

RECRUITING

MeSH Terms

Conditions

GingivitisPeriodontal Diseases

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Sealed envelopes
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study was designed as a double-blind randomized controlled trial (RCT) with 2 parallel groups of individuals with gingivitis
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 16, 2024

First Posted

January 25, 2024

Study Start

September 1, 2023

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

January 25, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

Study results

Shared Documents
STUDY PROTOCOL
Time Frame
1-year
Access Criteria
Pubmed

Locations

IT(1)