Ignite Creation Date:
2024-05-06 @ 6:00 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05511454
Status:
RECRUITING
Last Update Posted:
2023-07-13
First Post:
2022-08-19
Brief Title:
Comparison of Salivary and Crevicular Protein Concentrations of FIBA PLMN HEMO and ApoH in Healthy and Periodontitis Patients
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
Comparison of Salivary and Crevicular Protein Concentrations of FIBA PLMN HEMO and ApoH in Healthy and Periodontitis Patients
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PerioBioTIS
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 954 of the patients have a loss of attachment and 8223 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 p005
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 p005
Detailed Description:
Periodontitis can be defined as a multi-factorial infectious disease initiated by the accumulation of bacterial biofilm on the dental surfaces and causing the destruction of the supporting tissues of the tooth which can lead to the loss of the dental organ The high prevalence of these pathologies in the general population makes them an important subject to be considered in public health This prevalence varies from 56 to 82 The last epidemiological study in France carried out in 2002-2003 shows that 954 of patients have a loss of attachment and 8223 have associated periodontal pockets They are related to an imbalance between the microbiota and the host which will be more or less permissive with respect to the quantity andor the bacterial quality The presence of bacteria mostly Gram-negative anaerobes is not sufficient to explain the heterogeneity of clinical forms Indeed undetermined etiological factors create in some patients an environment favorable to the formation of periodontitis in particular genetic and predisposing factors
Periodontitis is characterized by variable clinical symptoms and signs that may include visible or non-visible inflammation spontaneous or provoked gingival bleeding of varying severity periodontal pocket formation related to attachment and alveolar bone loss tooth mobility and may lead to tooth loss In practice the diagnosis is based on the new Chicago classification but the etiological diagnosis is not so simple with the clinical and radiological tools available today Bacteriological tests exist to identify certain bacteria responsible for periodontitis but here again these tests are not sufficiently effective and studies show that there is a significant risk of false positives and negatives
Some research has been done on biomarkers found in periodontitis The PubMed database includes a few articles on salivary biomarkers and periodontitis including a systematic review dating from 2018 Among them the investigators mention the study that took place in 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 to the presence of periodontitis compared to the control group p005
PLMN lower level in periodontitis patients than in control patients
HEMO and FIBA higher levels in samples from patients with aggressive periodontitis
Apolipoprotein H has been identified as a differential diagnosis between aggressive and chronic periodontitis Its level is significantly higher in patients with aggressive periodontitis
All proteins correlated with periodontal disease are proteins of plasma origin
However this study is only interested in saliva However the proteins found are of plasma origin The crevicular fluid present in the sulcus is a plasma exudate that is easy to collect More and more studies are interested in this fluid It would therefore be interesting to analyze it in parallel with saliva
This assay of proteins in fluids can detect a maximum of 4 to 5 proteins in a multiplex assay and requires prior knowledge of the proteins being sought In order to open up the search for new biomarkers quantification techniques using mass spectrometry coupled with high-performance liquid chromatography provide extensive qualitative and quantitative characterisation of the peptidome and epitranscriptome Nowadays with the DIA Data Independent Acquisition mode multiplex detection can be extended to more than 1000 proteins in a single analysis as shown in a recent study by Sato et al The advantages of these techniques lie in their high specificity and sensitivity enabling the detection of thousands of proteins and multiple RNA modifications in micro-samples microlites
Periodontitis is characterized by variable clinical symptoms and signs that may include visible or non-visible inflammation spontaneous or provoked gingival bleeding of varying severity periodontal pocket formation related to attachment and alveolar bone loss tooth mobility and may lead to tooth loss In practice the diagnosis is based on the new Chicago classification but the etiological diagnosis is not so simple with the clinical and radiological tools available today Bacteriological tests exist to identify certain bacteria responsible for periodontitis but here again these tests are not sufficiently effective and studies show that there is a significant risk of false positives and negatives
Some research has been done on biomarkers found in periodontitis The PubMed database includes a few articles on salivary biomarkers and periodontitis including a systematic review dating from 2018 Among them the investigators mention the study that took place in 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 to the presence of periodontitis compared to the control group p005
PLMN lower level in periodontitis patients than in control patients
HEMO and FIBA higher levels in samples from patients with aggressive periodontitis
Apolipoprotein H has been identified as a differential diagnosis between aggressive and chronic periodontitis Its level is significantly higher in patients with aggressive periodontitis
All proteins correlated with periodontal disease are proteins of plasma origin
However this study is only interested in saliva However the proteins found are of plasma origin The crevicular fluid present in the sulcus is a plasma exudate that is easy to collect More and more studies are interested in this fluid It would therefore be interesting to analyze it in parallel with saliva
This assay of proteins in fluids can detect a maximum of 4 to 5 proteins in a multiplex assay and requires prior knowledge of the proteins being sought In order to open up the search for new biomarkers quantification techniques using mass spectrometry coupled with high-performance liquid chromatography provide extensive qualitative and quantitative characterisation of the peptidome and epitranscriptome Nowadays with the DIA Data Independent Acquisition mode multiplex detection can be extended to more than 1000 proteins in a single analysis as shown in a recent study by Sato et al The advantages of these techniques lie in their high specificity and sensitivity enabling the detection of thousands of proteins and multiple RNA modifications in micro-samples microlites
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None