Influence of the Restorative Cervical Margin Placement on... | NCT04299347

Studies
Influence of the Restorative Cervical Margin Placement on the Supracrestal Tissue Attachment

NCT04299347

Sponsor

University of Siena

Status

Completed

Last Update Posted

Mar 6, 2020Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Gingivitis

Interventions

Not provided

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

Mar 2020

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

Nov 29, 2018Actual

Primary Completion Date

Jun 29, 2019Actual

Completion Date

Mar 3, 2020Actual

First Submitted Date

Mar 4, 2020

First Submission Date that Met QC Criteria

Mar 4, 2020

First Posted Date

Mar 6, 2020Actual

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

Mar 4, 2020

Last Update Posted Date

Mar 6, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 present study is to understand the influence that marginal/subgingival restorations exert on the surrounding periodontal tissues. Even though proximal restorations are routine in everyday clinical practice, few information is available as to whether or not they may have a detrimental effect on the supracrestal tissue attachment.

Detailed Description

Not provided

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

Retention

Enrollment

40Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bleeding on Probing	bleeding from the gingival sulcus when probing	12 months

Secondary Outcomes

Measure	Description	Time Frame
radiographic distance from the caries/margin of the restoration to the bone crest	LInear measurement between the most apical level of the restoration to the bone crest	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

an age range 18-70 years
a good general health
the ability to understand the phases of the trial and to stick to them for the whole length of the study
the ability of will to release a written informed consent
presence of a marginal cavity or a 2mm subgingival cavity
presence of a cavity subgingival > 2mm

Exclusion Criteria:

PPD>4mm
patients affected by active periodontal disease
patients smoking more than 10 cigarettes/pipes per day

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

Patients coming to the Endodontic and Restorative department of Policlinico le Scotte- Siena, when eligible, were included in the study.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
AOUS		Siena		53100	Italy

Condition Browse Module

MeSH Terms

ID	Term
D005891	Gingivitis

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided