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The influence of apical periodontitis on the concentration of inflammatory mediators in peripheral blood plasma and the metagenomic profiling of endodontic infections.

The influence of apical periodontitis on the concentration of inflammatory mediators in peripheral blood plasma and the metagenomic profiling of endodontic infections.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON23636
Enrollment
60
Registered
2017-01-17
Start date
2017-01-18
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

apical periodontitis, parodontitis apicalis oral inflammation, ontsteking in de mond root canal infection, wortelkanaalinfectie endodontic, endodontisch health, gezondheid systemic health, algehele gezondheid low-grade inflammation, lage-graad ontsteking

Interventions

This is a prospective cohort study. Each subject will be followed for approximately 20 weeks. Subjects with one tooth with apical periodontitis to be treated with tooth extraction will be included. S

Sponsors

Academic Centre Dentistry Amsterdam (ACTA), Amsterdam, The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria AP group In order to be eligible to participate in this study, a subject must meet all of the following criteria. - The subject is 18 - 80 years old. - After intra-oral examination, AP has been confirmed with an intra-oral radiograph and appears on the radiograph as a radiolucent area around one or more root tips of the affected tooth. AP is diagnosed when in the periapical region, the periodontal ligament is at least twice as wide as in the mid-root regions. A root canal treatment has a poor prognosis or the patient would rather have the affected tooth extracted. The AP tooth is non-symptomatic. - No other teeth have AP. To confirm this, front teeth are clinically examined. Discoloured teeth or teeth with restorations that do not respond to cold testing or that are tender to percussion or palpation will also be examined with an intra-oral radiograph. In the (pre)molar region, recent bite-wing radiographs are used to screen for deep restorations or dental caries. When there are doubts about the vitality of restored or decayed (pre)molars an additional radiograph is taken. - The subject has completed the medical history questionnaire. - The subject wants to participate and donate six blood samples at six different time points and the subject wants to donate the extracted tooth. The subject has signed the IC letter. - The subject will not undergo dental hygienist’ treatments during the study. Inclusion criteria control group - The subject is 18 - 80 years old. - The subject has not had endodontic treatment in the past or previously root-canal treated teeth show no signs or symptoms of AP. - The subject has completed the medical history questionnaire and is classified as healthy. - The subject wants to participate and donate six blood samples at six different time points and the subject wants to donate the extracted tooth. The subject has signed the IC letter. - The subject will not undergo dental hygienist’ treatments during the study.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - smoking - pregnancy or lactation - diabetes mellitus type I - chronic inflammatory diseases like m. Crohn - use of antibiotics 1 month prior with an indication other than AP of the aimed tooth. - use of corticosteroids or NSAIDs - chemotherapy or previous head/neck irradiation - any surgery 6 months prior - any existing extra-oral swelling - malaise, colds or influenza one week before or at the start of the study - prosthesis carriers with stomatitis - absence of periapical radiolucency in the presence of tenderness to percussion. - absence of periapical radiolucency in the absence of sensitivity - previous surgery on tooth considered - vertical root fracture of tooth considered - localised periodontitis affecting tooth considered with absence of periodontal disease at other sites A potential subject who meets any of the following criteria will be excluded from participation in this study: - smoking - pregnancy or lactation - diabetes mellitus type I - chronic inflammatory diseases like m. Crohn - use of antibiotics 1 month prior - use of corticosteroids or NSAIDs - chemotherapy or previous head/neck irradiation - any surgery 6 months prior - any existing extra-oral swelling - malaise, colds or influenza one week before or at the start of the study - prosthesis carriers with stomatitis

Design outcomes

Primary

MeasureTime frame
Changes in concentration of mediators of inflammation compared non-AP controls (i) and to baseline measurements (ii). Determination of the magnitude of the microbial infection. Determination of composition and function profile of infected AP teeth.

Secondary

MeasureTime frame
Presentation of cytokine timelines of resolution of AP plus healing of extraction site. Determination of clusters of inflammatory mediators at time points S1- S6. Correlation of subject characteristics (symptoms of AP, DMFS and DPSI, age and sex) to mediators of inflammation or clusters thereof. Correlation of subject characteristics (symptoms of AP, DMFS and DPSI, age and sex) to qualitative and quantitative data of microbial content of extracted teeth.

Contacts

Public ContactS.V. van der Waal

Academisch Centrum Tandheelkunde Amsterdam, Amsterdam, Netherlands

s.vd.waal@acta.nl0031205980880

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)