Severity of Periodontal Recession and Associated Risk Factors in France. (Recession)

November 20, 2019 updated by: Central Hospital, Nancy, France

Severity of Periodontal Recession by Patient and Associated Risk Factors in France.

The severity of periodontal recessions for each examined patient during dental consultation was evaluated. Moreover, the description of the number of periodontal recessions in patients with good health during dental consultation, the associated risk factors and evaluation of the number of recessions which need surgical therapy were realized.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients are selected during a dental consultation.

Description

Inclusion Criteria:

Case:

  • patients aged from 20 to 50 years
  • patients with recession of more than 1mm
  • patient with good health
  • patients who aggreed to participate to the study

Controls:

  • patients aged from 20 to 50 years
  • patients with no recession or recession less than 1mm
  • patient with good health
  • patients who aggreed to participate to the study

Exclusion Criteria:

  • patients with periodontitis
  • patients with recession of Class III and IV of modified Miller classification
  • patients with previous muco-gingival surgery
  • patients pregnant, breatheeding
  • patients refusing to participate to the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case -
Patient presenting one or more periodontal recession more than 1mm of height
Other: Clinical examination of gingival tissues
Measure of the periodontal recession
Control-
Patient presenting no periodontal recession or recession of less than 1 mm of height
Other: Clinical examination of gingival tissues
Measure of the periodontal recession

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of periodontal recession severity
Time Frame: Observation at day 1
Measure of the height and the width of periodontal recession (millimeter)
Observation at day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of recessions for each patient
Time Frame: Observation at day 1
Evaluation of the number of recessions for each patient
Observation at day 1
Associated risk factors
Time Frame: Observation at day 1
Evaluation of smoking status, general health, periodontum and dental parameters, evaluation of toothbrush and dental treatment
Observation at day 1
Number of participants with recession-related adverse events as assessed by questionnaire
Time Frame: Observation at day 1
Evaluation of the needs of surgical treatment of the periodontal recessions observed according to pain evaluated by questionnaire
Observation at day 1
Frequency of periodontal recession according to the modified Miller classifcation
Time Frame: Observation at day 1
Measure of the periodontal recession according to the modified Miller classification
Observation at day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Catherine BISSON, Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2017

Primary Completion (Actual)

February 6, 2017

Study Completion (Anticipated)

February 5, 2021

Study Registration Dates

First Submitted

August 20, 2019

First Submitted That Met QC Criteria

November 20, 2019

First Posted (Actual)

November 25, 2019

Study Record Updates

Last Update Posted (Actual)

November 25, 2019

Last Update Submitted That Met QC Criteria

November 20, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • PSS2016/RECESSION-BISSON/MS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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