Endodontic Root-canal Treatments Evaluated After Long-ter... | NCT03215225

Studies
Endodontic Root-canal Treatments Evaluated After Long-term Time

NCT03215225

Sponsor

University of Bologna

Status

Completed

Last Update Posted

Jul 12, 2017Actual

Enrollment

130Actual

Phase

Not provided

Conditions

Root Canal Treatment
Endodontic Disease

Interventions

Root canal orthograde treatment

Countries

Not provided

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

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 1989Actual

Primary Completion Date

Dec 20, 2016Actual

Completion Date

Jun 2, 2017Actual

First Submitted Date

Jul 9, 2017

First Submission Date that Met QC Criteria

Jul 9, 2017

First Posted Date

Jul 12, 2017Actual

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

Jul 9, 2017

Last Update Posted Date

Jul 12, 2017Actual

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 aim of the study was to evaluate the root canal treatments performed from 1989 to 1995. Type of complication, success, new endodontic diseases and number of success were reported. Mean clinical parameters were clinical symptoms and presence/absence of apical radiolucency.

Detailed Description

See previous papers (Pirani et al., Odontology, 2015)

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

130Actual

Label	Type	Description	Intervention Names
Root canal treatment			Procedure: Root canal orthograde treatment

Name	Type	Description	Arm Group Labels	Other Names
Root canal orthograde treatment	Procedure		Root canal treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Health Patients	patients with periapical disease and/or pulpal disease	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients affected by endodontic disease and able to attend a recall hygien program

Exclusion Criteria:

Sistemic disease Cancer Inability to attend a recall hygien program

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

Similar geographic provenience

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003788	Dental Pulp Diseases

Ancestor Terms

ID	Term
D014076	Tooth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided