Periodontal Diseases
Conditions
Keywords
periodontal diseases, saliva, biomarkers, prediction, periodontopathogens, interleukin 1, MMP-8
Brief summary
Objective: The main aim of this longitudinal clinical study is to evaluate the predictive ability of a panel of salivary biomarkers in determining periodontal health status in 2 years follow up in a group of healthy and periodontally affected individuals. Material and methods: In this longitudinal, observational follow-up study, patients previously enrolled in a cross-sectional study at the Periodontal Postgraduate Clinic, University Complutense of Madrid, will be re-evaluated over a 2-year period. Participants (≥18 years) will be categorized into diagnostic groups based on the 2018 classification of periodontal diseases, including periodontally healthy, gingivitis, treated periodontitis (stable/unstable), and various stages of periodontitis. The study will include follow-up visits at 1 and 2 years. At each visit, participants will undergo a comprehensive medical examination to assess age, gender, weight, height, waist circumference, blood pressure, temperature, smoking and alcohol history, systemic health, and HbA1c levels. A periodontal examination will be performed at six sites per tooth, and clinical parameters including plaque, bleeding on probing, probing depth, recession, and tooth loss will be recorded. Saliva and subgingival plaque samples will be collected for biomarker and microbiological analysis. Salivary biomarkers will be measured using multiplex immunoassays, and bacterial quantification will be performed by multiplex qPCR. Data analyses: Descriptive statistics will be used to report the clinical variables and patients will be grouped according to the pre-established diagnostic categories (periodontally healthy, gingivitis, treated periodontitis patient. In order to determine the possible statistical relationship with the medical, biochemical and microbiological variables assessed, a crude bivariate analysis will first be performed by applying a mean comparison test for quantitative variables (ANOVA) and a proportion comparison test for categorical variables (Chi-square). Subsequently, those variables identified as relevant in the crude analyses will be included as confounding and/or interaction factors in a binary logistic regression model, considering the presence of periodontitis as a response variable, in order to obtain crude and adjusted OR values, together with their corresponding 95% CIs. Based on the results obtained in the biomarker analysis, a relevant statistical analysis will be performed, taking into account all the variables collected in the study. For periodontitis cases, treatment response over time will be analyzed, with subgroup comparisons between responders and non-responders.
Interventions
OTHERNo intervention
There is not intervention in these patients, appart from their normal dental check-up visits.
Sponsors
Universidad Complutense de Madrid
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participants from the cohort involved in the previous cross-sectional study (code 23/481-E). * Adults (≥ 18-year-old) * Being able to sign an informed consent form * Willing to participate in this observational investigation * Diagnosed as periodontally healthy, gingivitis, treated periodontitis patient (stable / unstable), periodontitis stages I \& II, or periodontitis stages III and IV (Papapanou et al. 2023) in the previous cross-sectional study (code 23/481-E)
Exclusion criteria
* Patients fitting to all the above inclusion criteria will be excluded from the study if unable to attend to the study-related procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Salivary biomarkers | Baseline, 1 and 2 years | Concentrations of specific biomarkers (IL-1 and MMP-8) analyzed using multiplex commercial diagnostic tests. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Age | Baseline, 1 and 2 years | Participant's age in years. |
| Gender | Baseline, 1 and 2 years | Gender |
| Weight | Baseline, 1 and 2 years | Weight (kg) |
| Height | Baseline, 1 and 2 years | Height (cm) |
| Waist circumference | Baseline, 1 and 2 years | A measuring tape will be used, and the determination will be made above the hip bone |
| HbA1c | Baseline, 1 and 2 years | Following the instructions from the manufacturer of the device (A1CNow+; Bayer) and diabetic risk questionnaire (Finn-risk) |
| Blood pressure | Baseline, 1 and 2 years | The procedure will follow the recommendations in the clinical practice guidelines of the American Heart Association (AHA) {Whelton, 2018 #466}. In summary, a validated and approved blood pressure monitor (Omron M6 COMFORT IT HEM-7322U-E) will be used with the patient seated, back straight, and arms supported at heart level. After the initial measurement, there will be a 5-minute rest period before taking a second reading. The average of the two readings will be considered valid. |
| Temperature | Baseline, 1 and 2 years | Participant's body temperature in degrees Celsius. |
| Drug, alcohol, and smoking history | Baseline, 1 and 2 years | History of participant's drug, alcohol, and smoking habits. |
| Nicotine dependency | Baseline, 1 and 2 years | Assessment of nicotine dependency using the Fagerström Test for Nicotine Dependence. |
| Health anamnesis | Baseline, 1 and 2 years | Relevant systemic health information collected through a complete health history questionnaire |
| Presence and quantification of specific periodontal pathogens | Baseline, 1 and 2 years | P. gingivalis, A. actinomycetemcomitans, T. forsythia detected through real time PCR analysis |
| Plaque index | Baseline, 1 and 2 years | categorized as presence/absence |
| Bleeding on probing | Baseline, 1 and 2 years | assessed dichotomously within 15 seconds after probing |
| Suppuration on probing | Baseline, 1 and 2 years | assessed dichotomously within 15 seconds after probing |
| Probing depth | Baseline, 1 and 2 years | defined as the distance in mm between the bottom of the pocket and the gingival margin |
| Recession | Baseline, 1 and 2 years | defined as the distance in mm between the amelocemental boundary and the gingival margin. The sum of probing depth and recession will determine the patient's clinical attachment loss |
| Number of teeth lost and reason | Baseline, 1 and 2 years | Number of teeth lost and reason |
Countries
Spain
Contacts
CONTACTElena Figuero, Prof.
CONTACTMariano Sanz, Prof.
Outcome results
None listed