RELATIONSHIP BETWEEN PERIODONTITIS AND INFLAMMATORY MARKERS

Study on the relationship between periodontal disease and serum levels of ultrasensitive Reactive C-Protein and fibrinogen - PERIODONTITIS AND INFLAMMATORY MARKERS

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002239-27-ES

Enrollment

123

Registered

2019-07-26

Start date

2019-09-24

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with a diagnosis of periodontitis: There is interdental LCI in two or more non-adjacent teeth, or two or more teeth have a vestibular LCI = 3 with a PD > 3 mm

Interventions

Trade Name: LIGOSAN Product Name: Doxiciclina Product Code: Código ATC: A01AB22 Pharmaceutical Form: Dental gel INN or Proposed INN: DOX

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patients with a Probing Depth > 3 mm in at least oneprobing site in two or more teeth Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 63

Exclusion criteria

Exclusion criteria: Exclusion criteria: Patients who have total edentulism, have received periodontal treatment in the last year, there being a decrease in inflammatory activity, are pregnant or breastfeeding, given the immunological tolerance during pregnancy, they are diagnosed of ulceronecrotizing gingivitis (NUG), being an acute process, ulceronecrotizing periodontitis (NUP), being an acute process or diagnosed with HIV, due to the state of immunosuppression, recent history of angina, myocardial infarction or CVA, since they suppose a confusion factor when elevating the serum levels of the biomarkers, antecedents of acute inflammatory processes or recent traumatisms, suffer chronic ingestion of non-steroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids, decrease the immune and inflammatory response, have taken antibiotics in the last three months, since they decrease the inflammatory activity and therefore the serum levels of biomarkers.

Design outcomes

Primary

Measure	Time frame
Main Objective: Study the relationship between periodontal disease and the level of ultra sensitive Reactive C Protein and Fibrinogen.; Secondary Objective: 1. Establish the relationship between the different clinical variables of the periodontal study, with the value of PCRus 2. To establish the relationship between the different clinical variables of the periodontal study, with the serum level of Fibrinogen. 3. To establish the relationship between the different clinical variables of the periodontal study before and after the non-surgical periodontal treatment, and the serum levels of CRP and Fibrinogen. 4. To quantify the impact of the use of topical Doxycycline, as an adjuvant medication for periodontal treatment, on the serum levels of CRP and Fibrinogen. 5. Quantify the impact of the patient's profile, determined by the confounding variables, on the serum levels of CRP and Fibrinogen. ;Primary end point(s): Study the relationship between periodontal disease and the level of ultrasensitive Reactive C Protein and Fibrinogen.;Timepoint(s) of evaluation of this end point: The re-evaluation will be carried out three months after the end of periodontal treatment, since the biofilm is restructured during this period of time	—

Measure

Time frame

Main Objective: Study the relationship between periodontal disease and the level of ultra sensitive Reactive C Protein and Fibrinogen.; Secondary Objective: 1. Establish the relationship between the different clinical variables of the periodontal study, with the value of PCRus 2. To establish the relationship between the different clinical variables of the periodontal study, with the serum level of Fibrinogen. 3. To establish the relationship between the different clinical variables of the periodontal study before and after the non-surgical periodontal treatment, and the serum levels of CRP and Fibrinogen. 4. To quantify the impact of the use of topical Doxycycline, as an adjuvant medication for periodontal treatment, on the serum levels of CRP and Fibrinogen. 5. Quantify the impact of the patient's profile, determined by the confounding variables, on the serum levels of CRP and Fibrinogen. ;Primary end point(s): Study the relationship between periodontal disease and the level of ultrasensitive Reactive C Protein and Fibrinogen.;Timepoint(s) of evaluation of this end point: The re-evaluation will be carried out three months after the end of periodontal treatment, since the biofilm is restructured during this period of time

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Establish the relationship between the different clinical variables of the periodontal study, with the value of PCRus 2. To establish the relationship between the different clinical variables of the periodontal study, with the serum level of Fibrinogen. 3. To establish the relationship between the different clinical variables of the periodontal study before and after the non-surgical periodontal treatment, and the serum levels of CRP and Fibrinogen. 4. To quantify the impact of the use of topical Doxycycline, as an adjuvant medication for periodontal treatment, on the serum levels of CRP and Fibrinogen. 5. Quantify the impact of the patient's profile, determined by the confounding variables, on the serum levels of CRP and Fibrinogen. ;Timepoint(s) of evaluation of this end point: The re-evaluation will be carried out three months after the end of periodontal treatment, since the biofilm is restructured during this period of time	—

Measure

Time frame

Secondary end point(s): 1. Establish the relationship between the different clinical variables of the periodontal study, with the value of PCRus 2. To establish the relationship between the different clinical variables of the periodontal study, with the serum level of Fibrinogen. 3. To establish the relationship between the different clinical variables of the periodontal study before and after the non-surgical periodontal treatment, and the serum levels of CRP and Fibrinogen. 4. To quantify the impact of the use of topical Doxycycline, as an adjuvant medication for periodontal treatment, on the serum levels of CRP and Fibrinogen. 5. Quantify the impact of the patient's profile, determined by the confounding variables, on the serum levels of CRP and Fibrinogen. ;Timepoint(s) of evaluation of this end point: The re-evaluation will be carried out three months after the end of periodontal treatment, since the biofilm is restructured during this period of time

—

Countries

Spain

Contacts

Public ContactRicardo Andreu

Clinica Dental AndreuDental

r.andreu58@icloud.com0034961384415

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026