Comparison of Salivary and Crevicular Protein Concentrations of FIBA, PLMN, HEMO and ApoH in Healthy and Periodontitis Patients
PerioBioTIS
1 other identifier
interventional
118
1 country
1
Brief Summary
Periodontal disease is a multifactorial inflammatory disease of infectious origin. The last epidemiological study concerning periodontitis in France was carried out in 2002-2003 by Bourgeois et al and shows that 95.4% of the patients have a loss of attachment and 82.23% have associated periodontal pockets. The presence of bacteria, mostly Gram-negative anaerobes, is not sufficient to explain the heterogeneity of clinical forms. Indeed, there are different risk factors influencing the frequency and severity of periodontitis. Moreover, the link between systemic pathologies and periodontitis has been widely established: it concerns metabolic syndromes, cardiovascular pathologies, premature pregnancies, autoimmune diseases and Alzheimer disease. Some research has been done on biomarkers found in periodontitis. Among them, the investigators quote the study which took place within the laboratory of Biochemistry - Clinical Proteomics of Pr Lehmann Sylvain by Mertens et al. It is the only study to date that has established an LC-MRM proteomic profile characteristic of periodontitis: indeed, 4 proteins of plasma origin were highlighted thanks to this technology: hemopexin (HEMO), plasminogen (PLMN), apolipoprotein H and α-fibrinogen (FIBA) were correlated with the presence of periodontitis compared to the control group (p\<0.05).
Trial Health
Trial Health Score
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participants targeted
Target at P50-P75 for not_applicable
Started Jun 2023
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2022
CompletedFirst Posted
Study publicly available on registry
August 23, 2022
CompletedStudy Start
First participant enrolled
June 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 22, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedJuly 13, 2023
July 1, 2023
1.5 years
August 19, 2022
July 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of plasma protein concentration between the two groups
Salivary and crevicular concentrations of each of the plasma proteins (FIBA, PLMN, ApoH, HEMO), measured by ELISA in the case and control groups (in µg/mL). Salivary and crevicular samples will be analyzed using specific ultra-sensitive Meso Scale Discovery (MSD) immunoassay kits.
1 day
Secondary Outcomes (5)
Comparison of plasma protein concentration according to the stages and grades of periodontitis (in case group).
1 day
Comparison of plasma protein concentration according to the presence or absence of diabetes (in case group).
1 day
Quantitative measure
1 day
Comparison of salivary and crevicular protein profiles and protein levels after mass spectrometry analysis between subjects with periodontitis and a control group
1 day
Comparison of level of free nucleosides found in saliva and crevicular fluid by mass spectrometry between subjects with periodontitis and a control group.
1 day
Study Arms (2)
Group of patients with periodontitis (cases)
EXPERIMENTALPatients with periodontitis according to the Chicago 2018 classification criteria
Control group
OTHERPatients with periodontal health according to the 2018 Chicago Classification
Interventions
The samples will be taken from patients in both groups who meet the selection criteria during consultations at the Montpellier University Hospital's Odontology Department. During these consultations, a sample will be taken after rinsing the oral cavity with a glass of water. The samples will be taken before the periodontal assessment in order to avoid bleeding.
Eligibility Criteria
You may qualify if:
- Control Group:
- Patients consulting the Center for Dental Care, Education and Research for the care of their periodontal pathology.
- Patients with periodontal health according to the 2018 Chicago Classification.
- Case Group:
- Patients consulting the Center for Dental Care, Education and Research for the care of their periodontal pathology.
- Patients with periodontitis according to the Chicago 2018 classification criteria.
You may not qualify if:
- General:
- Pregnancy in progress or planned during the study period, Pregnant or breastfeeding women.
- Adult protected by law or patient under tutorship or curatorship.
- Participation in other ongoing biomedical research.
- Failure to obtain written informed consent after a reflection period.
- Not be affiliated to a French social security system or a beneficiary of such a system.
- Case Group:
- Patients with previous periodontal treatment or maintenance.
- Control Group:
- There is no prohibition against subjects participating in other research simultaneously.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre de Soins Dentaires
Montpellier, 34090, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2022
First Posted
August 23, 2022
Study Start
June 22, 2023
Primary Completion
December 22, 2024
Study Completion
March 1, 2025
Last Updated
July 13, 2023
Record last verified: 2023-07