Impact of Periodontal Supportive Therapy in Patients With... | NCT06382753

Studies
Impact of Periodontal Supportive Therapy in Patients With Gingivitis and Periodontitis

NCT06382753

Sponsor

University of Catania

Status

Unknown status

Last Update Posted

Apr 24, 2024Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Gingivitis
Periodontitis

Interventions

Gingival inflammation

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

Apr 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

Apr 20, 2024Actual

Primary Completion Date

Jun 30, 2024Estimated

Completion Date

Jun 30, 2024Estimated

First Submitted Date

Apr 20, 2024

First Submission Date that Met QC Criteria

Apr 20, 2024

First Posted Date

Apr 24, 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

Apr 20, 2024

Last Update Posted Date

Apr 24, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

The study evaluated the number of sessions of periodontal supportive treatment in patients with gingivitis in order to evaluate the risk of periodontitis development.

Detailed Description

Patient with gingivitis were retrospectively evaluated. The number of periodontal supportive therapy were recorded other than gingivitis periodontal parameters over 5-years follow-up.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gingival inflammation	Other	Patients were scored for their status of gingival inflammation using Gingival Index and Bleeding on Probing Scores

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bleeding on Probing	Evaluation of bleeding on probing reduction	5-years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of Gingivitis

Exclusion Criteria:

Diagnosis of Periodontitis
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

70 Years

Standard Ages

AdultOlder Adult

Study Population

150 patients with diagnosed gingivitis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gaetano Isola	Contact	0953785652		gaetano.isola@unict.it
Rosalia Leonardi	Contact	0953785652		rleonardi@unict.it

Overall Officials

Name	Affiliation	Role
Gaetano Isola	University of Catania	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AOU Policlinico G. Rodolico	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

http://pubmed.gov

Condition Browse Module

MeSH Terms

ID	Term
D005891	Gingivitis
D010518	Periodontitis

Ancestor Terms

ID	Term
D007239	Infections
D005882	Gingival Diseases
D010510	Periodontal Diseases
D009059	Mouth Diseases

Browse Leaves

Not provided

Browse Branches

Not provided