NCT02568163

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

October 5, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

August 21, 2019

Status Verified

August 1, 2019

Enrollment Period

4.6 years

First QC Date

June 25, 2013

Last Update Submit

August 19, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changing depths of periodontal pockets

    6 months

Study Arms (1)

questionary

OTHER
Other: Non surgical periodontal treatment

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de parodontologie

Strasbourg, Bas Rhin, 67000, France

Location

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2013

First Posted

October 5, 2015

Study Start

September 1, 2013

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

August 21, 2019

Record last verified: 2019-08

Locations