Antimicrobial Peptides in Periodontitis (PAROPAM)

March 29, 2017 updated by: CHU de Reims

Antimicrobial Peptides in Periodontitis : a Pilot Study

Periodontal diseases are complex chronic pathologies presenting a high prevalence worldwide. Etiopathological process involved in initiation and progression of these multifactorial diseases are not well understood, explaining the huge clinical forms variability and the complexity of the currently used classification of periodontal diseases. Recently, the implication of antimicrobial peptides (AMPs) have been suggested as potential track of explanation for periodontal diseases pathogeny. The here presented study explore the level of expression of genes coding those peptides by studying periodontal smears obtained from healthy and periodontitis patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study explore the level of expression of genes coding those peptides by studying Messenger RNA (mRNA) purified from periodontal smears obtained from healthy and periodontitis patients by "Masterpure©" protocol.After reverse transcription (RT-PCR), in-silico design of primers and specificity and efficiency calculation, Complementary DNA (cDNA) are quantified by a semi-quantitative method (delta-delta CT) vs a Housekeeping gene. Wilcoxon-Mann & Whitney tests and Chi² tests are performed to check the significativity of the results between groups.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

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

  • France
      • Reims, France, 51092
        • CHU de Reims

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

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients suffering of moderate to severe chronic periodontitis as described by the classification Armitage-1999, aged 35-65yo

Exclusion Criteria:

  • Pregnant females, patients suffered from any other systemic diseases (cardiovascular, pulmonary, liver, cerebral, diseases or diabetes, cancer)
  • patients that had received antibiotic treatment in the previous 3 months or who were taking long-term anti-inflammatory drugs; who had received a course of periodontal treatment or orthodontics treatment within the last 6 months; who were heavy smokers (>5 cig/day)

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

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Diseased
Patients suffering of moderate to severe chronic periodontitis
Other: periodontal smears
Other: Healthy
Healthy Patients not suffering of any periodontal disease a
Other: periodontal smears

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antimicrobial peptides expression levels
Time Frame: Day 0
Level of expression of antimicrobial peptides assessed by RT-PCR
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mRNA quantity
Time Frame: Day 0
Quantity of mRNA purified on the smears
Day 0

Collaborators and Investigators

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

Sponsor

CHU de Reims

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 19, 2016

Primary Completion (Actual)

March 23, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

May 27, 2016

First Submitted That Met QC Criteria

June 2, 2016

First Posted (Estimate)

June 8, 2016

Study Record Updates

Last Update Posted (Actual)

March 30, 2017

Last Update Submitted That Met QC Criteria

March 29, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PO15100

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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