Influence of Stress on Non Surgical Periodontal Treatment | NCT02568163

Studies
Influence of Stress on Non Surgical Periodontal Treatment

NCT02568163

Sponsor

University Hospital, Strasbourg, France

Status

Terminated

Last Update Posted

Aug 21, 2019Actual

Enrollment

72Actual

Phase

Not Applicable

Conditions

Chronic Periodontitis

Interventions

Non surgical periodontal treatment

Countries

France

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

Aug 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The number of subjects were underestimated, which implies a reduction in the number of subjects required.

Expanded Access Info

Start Date

Sep 2013Actual

Primary Completion Date

Apr 2018Actual

Completion Date

Apr 2018Actual

First Submitted Date

Jun 25, 2013

First Submission Date that Met QC Criteria

Oct 1, 2015

First Posted Date

Oct 5, 2015Estimated

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

Aug 19, 2019

Last Update Posted Date

Aug 21, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Treatment of periodontal diseases is influenced by several risk factors. Psychological stress is considered as one of them. Aim of this study is to assess if stress influences results of non surgical periodontal treatment in severe chronic forms of periodontitis.

Detailed Description

Not provided

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

72Actual

Label	Type	Description	Intervention Names
questionary	Other		Other: Non surgical periodontal treatment

Name	Type	Description	Arm Group Labels	Other Names
Non surgical periodontal treatment	Other		questionary

Measure	Description	Time Frame
Changing depths of periodontal pockets		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Severe generalized chronic periodontitis
Minimum 15 teeth
Attachment loss > 5mm
30% of sites affected- 5% of pockets>5mm
Bone loss- Bleeding on probing

Exclusion Criteria:

Patient at risk of endocarditis
Pregnant women
Patient under therapy for depression
Patient treated for periodontal diseases previously

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

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
Service de parodontologie		Strasbourg	Bas Rhin	67000	France

Condition Browse Module

MeSH Terms

ID	Term
D055113	Chronic Periodontitis

Ancestor Terms

ID	Term
D010518	Periodontitis
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided