Toothpaste With Sodium Carbonate in Patients With Gingivitis | NCT06224699

Studies
Toothpaste With Sodium Carbonate in Patients With Gingivitis

NCT06224699

Sponsor

University of Catania

Status

Unknown status

Last Update Posted

Jan 25, 2024Actual

Enrollment

44Estimated

Phase

Not Applicable

Conditions

Gingivitis
Periodontal Diseases

Interventions

Toothpaste Product

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2023Actual

Primary Completion Date

Mar 1, 2024Estimated

Completion Date

Mar 1, 2024Estimated

First Submitted Date

Jan 16, 2024

First Submission Date that Met QC Criteria

Jan 16, 2024

First Posted Date

Jan 25, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2024

Last Update Posted Date

Jan 25, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Toothpaste Product	Drug	Use of toothpaste with or without sodium carbonate at 67%	Control Test group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Gingival index (1-4)	Gingival index reduction	6-months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AOU Policlinico Catania	Recruiting	Catania		95124	Italy

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Study results

Types

Study Protocol

Time Frame

1-year

Access Criteria

Pubmed

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005891	Gingivitis
D010510	Periodontal Diseases

Ancestor Terms

ID	Term
D007239	Infections
D005882	Gingival Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided