Investigation of matrix metalloproteinase-9 levels in dental pulp blood as a marker for the inflammatory state of the pulp tissue - a prospective clinical pilot study

Not Applicable

• Conditions: K02.1; K02.5; Caries of dentine; Caries with pulp exposure

• Registration Number: DRKS00030346
• Lead Sponsor: Poliklinik für ZahnerhaltungskundeUniversitätsklinikum Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Male and female patients of the age = 12 years
- Patients from the Department of Conservative Dentistry at Clinic for Oral, Dental and Maxillofacial Diseases, University Hospital Heidelberg or from one of the cooperating trial centres
- Present declaration of consent of the patient to participate in the study; in the case of underage patients, the consent of the legal guardian/legal representative must also be present
- Adult patients must be able to give consent
- Teeth in which (the clearly vital) pulp of a tooth with a caries extending into the pulp resulting in pulp exposure during caries excavation.
- The pulp tissue of the treated tooth must be classified either as completely asymptomatic, reversibly inflamed (reversible pulpitis) or irreversibly inflamed (irreversible pulpitis).
- The tooth must be treatable and restorable under rubber dam isolation.
- The restoration of the tooth after partial pulpotomy and subsequent direct pulp capping with ProRoot MTA® using composite must be completed within 24 hours.

Exclusion Criteria

- Primary teeth
- Patients whose state of health is reduced to such an extent that they are not able to cope with the usual stress (e.g. immunocompromised patients)
- Patients for the period of their pregnancy
- Patients who have not yet reached the age of 12
- Patients who do not give their consent to participate in the study
- Patients who have taken antibiotics in the last four weeks
- Patients who have taken medicaments with a potential influence on the MMP-9 level, e.g. bisphosphonates, statins, acetylsalicylic acid (exception is group 3, in which patients have taken the NSAID Ibuprofen)
- Teeth that have a longitudinal fracture at the time of the treatment with partial pulpotomy
- Teeth which, at the time of the treatment, showed bone loss down to the apical third of the root, teeth with a perio-endo-lesion or teeth with a degree of mobility of 3
- Teeth that showed at the periapical radiograph a periapical index PAI=2 at the day of the treatment (arm 1 and 2 with partial pulpotomy)
- Teeth that showed at the periapical radiograph a periapical index PAI>2 at the day of the treatment (arm 3 and 4 with root canal treatment). Teeth in which an internal or external tooth/root resorption is already evident at day of the treatment with partial pulpotomy,
- Teeth that could not be assigned unequivocally to one of the four diagnostic groups after clinical and radiographic examination

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The aim of this study was to determine how the MMP-9 level obtained from the pulpal blood of teeth with an extremely deep carious lesion behave in asymptomatic teeth compared to teeth with reversible or irreversible pulpitis and whether conclusions can be drawn about the inflammatory state of the pulp, which may could facilitate the differential diagnosis between reversible and irreversible pulpitis.

Secondary Outcome Measures

Name	Time	Method
As secondary outcome criterion, the teeth that received a partial pulpotomy (group 1 and 2) should be followed up over an extended period of time, as there is a lack of clinical long-term results from this treatment option in regard of teeth with carious pulp exposure. The teeth of these two groups were initially followed up after 6 months and subsequently annually.