Back to resultsAntimicrobial Peptides in Periodontitis (PAROPAM)
Primary Purpose
Periodontal Disease : Chronic Periodontitis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
periodontal smears
Sponsored by
About this trial
This is an interventional diagnostic trial for Periodontal Disease : Chronic Periodontitis
Eligibility Criteria
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)
Sites / Locations
- Chu de Reims
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Diseased
Healthy
Arm Description
Patients suffering of moderate to severe chronic periodontitis
Healthy Patients not suffering of any periodontal disease a
Outcomes
Primary Outcome Measures
Antimicrobial peptides expression levels
Level of expression of antimicrobial peptides assessed by RT-PCR
Secondary Outcome Measures
mRNA quantity
Quantity of mRNA purified on the smears
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02793453
Brief Title
Antimicrobial Peptides in Periodontitis
Acronym
PAROPAM
Official Title
Antimicrobial Peptides in Periodontitis : a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 19, 2016 (Actual)
Primary Completion Date
March 23, 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Disease : Chronic Periodontitis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diseased
Arm Type
Other
Arm Description
Patients suffering of moderate to severe chronic periodontitis
Arm Title
Healthy
Arm Type
Other
Arm Description
Healthy Patients not suffering of any periodontal disease a
Intervention Type
Other
Intervention Name(s)
periodontal smears
Primary Outcome Measure Information:
Title
Antimicrobial peptides expression levels
Description
Level of expression of antimicrobial peptides assessed by RT-PCR
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
mRNA quantity
Description
Quantity of mRNA purified on the smears
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Chu de Reims
City
Reims
ZIP/Postal Code
51092
Country
France
12. IPD Sharing Statement
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Antimicrobial Peptides in Periodontitis
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