Evaluation of Dentinal Fluid for the Presence of Matrix Metalloproteinase 9 (MMP-9) in Pulpal Inflammation

NCT02967081 | Completed

• 1 other identifier: PB_2016-02043
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether dentinal fluid (tooth fluid) of teeth with or without a painful inflammatory condition in their nerve (pulp) contain inflammatory marker.

Conditions

Pulpitis

Keywords

Pulpitis; Biomarker; Diagnostic; Dentinal fluid

Outcome Measures

Primary Outcomes (1)

• Total matrix metalloproteinase 9 (MMP-9) level in dentinal fluid

  Immediately

Study Arms (4)

Pulp necrosis

Procedure: Collection of dentinal fluid using a cellulose membrane

Pulpitis (painless)

In this group the dentinal fluid will be sampled/collected twice: Firstly after the removal of the primary caries lesion. Subsequently the cavity will be temporized. Secondly, after removal of the temporary filling material (before final restoration).

Procedure: Collection of dentinal fluid using a cellulose membrane

Irreversible pulpitis

Procedure: Collection of dentinal fluid using a cellulose membrane

Normal pulp

Procedure: Collection of dentinal fluid using a cellulose membrane

Interventions

Collection of dentinal fluid using a cellulose membrane PROCEDURE

After removal of the caries lesion/filling a cellulose membrane (sterile paper point) will be applied with its blunt end to the dentin for 1 min to collect dentinal fluid.

Irreversible pulpitis; Normal pulp; Pulp necrosis; Pulpitis (painless)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients (≥18 y) who attend the University of Zurich, Center of Dental Medicine, Clinic of Preventive Dentistry, Periodontology and Cariology for dental treatment.

You may qualify if:

• Adult patients who attend the University of Zurich, Center of Dental Medicine, Clinic of Preventive Dentistry, Periodontology and Cariology that are in need for
• Treatment of pain related to pulpal inflammation
• Caries therapy
• Root canal treatment of a pulp-necrotic tooth
• Replacement of an defect/fractured filling

You may not qualify if:

• Children or adolescents (≤18 y)
• Patients who do not agree to participate in the study
• Patients with general diseases of inflammatory nature (such as diabetes, Crohn's disease, etc), or diseases affecting the immune-system (immuno-suppression, multiple morbidities, etc.)
• Women with known pregnancy
• Patients not fluent in German or English language
• Patients who had antibiotic or NSAID intake during the last 14 days
• Patients who refuse to be examined radiographically.

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University of Zurich, Center of Dental Medicine

Zurich, 8032, Switzerland

Location

Related Publications (1)

• Zehnder M, Wegehaupt FJ, Attin T. A first study on the usefulness of matrix metalloproteinase 9 from dentinal fluid to indicate pulp inflammation. J Endod. 2011 Jan;37(1):17-20. doi: 10.1016/j.joen.2010.10.003.

  PMID: 21146069 BACKGROUND

MeSH Terms

Conditions

Pulpitis; Disease

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2016
• First Posted: November 17, 2016
• Study Start: October 1, 2016
• Primary Completion: October 17, 2017
• Study Completion: October 17, 2017
• Last Updated: May 3, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)