PulpitisNCT02967081
Evaluation of Dentinal Fluid for the Presence of Matrix Metalloproteinase 9 (MMP-9) in Pulpal Inflammation
An observational study of Pulpitis, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulpitis
- What is being tested?
- Collection of dentinal fluid using a cellulose membrane
- Type of treatment
- Surgery or procedure
- How many people
- 67 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2016to 17 Oct 2017
- How long will I take part?
- 10 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Zurich, Center of Dental Medicine
Zurich, 8032
About this study
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.
Read the detailed description
Objective:
The aim of the study is to use an improved sampling method for collection of MMP-9 to test the hypothesis that MMP-9 levels are significantly elevated in the dentinal fluid of symptomatic (painful) human permanent teeth compared to asymptomatic counterparts that need replacement of a filling, and pulp necrotic teeth. Moreover, the dynamics of MMP-9 expression after removal of the causative stimulus for pulpitis is to be investigated.
Outcome:
Measuring the total MMP-9 levels of dentinal fluid collected during dental treatment using a human MMP-9 fluorescent assay.
Measurements and procedures:
Patients attending the day service of the Center of Dental Medicine Zurich will be screened. Patients matching the inclusion criteria will be asked to participate in the study. Upon written informed consent, the affected tooth gets anesthetized, isolated with rubber dam and receives one of the following treatment procedures: caries removal and restoration, tooth filling replacement and restoration, or root canal treatment (because of irreversible pulpitis, or pulp necrosis). After caries removal, removal of the defect tooth filling, or during access cavity preparation, a cellulose membrane (paper point) will be applied with its blunt end to the dentin for 1 min to collect dentinal fluid. The cellulose membrane will be stored until the laboratory analysis. Depending on the individual treatment plan of the patient, the tooth will subsequently receive root canal treatment, its final restoration, or a temporization with glass-ionomer cement for coverage of the dentinal wound and reinforcement of the remaining tooth structure. Final restoration of a tooth with composite, a partial crowns, or full-coverage crown can be technically demanding, time consuming, and frequently involves multiple patient visits. Teeth that receive root canal treatment, or the final restoration are sampled once. When a patient with a temporized tooth returns for the final restoration, the sampling procedure (appliance of a cellulose membrane to the dentin for 1 min and storage for further analyses) will be repeated. Any further treatment will be continued without further impairments. The investigation does not alter the treatment plan of any patient (either participating in one, or two sampling procedures, or in the study at all).
Number of participants:
Based on a previously performed study (Zehnder et al., 2011), which used a similar experimental set-up and had 31 participants (2 groups), it is aimed to recruit 60 participants for the current study.
Comparators:
MMP-9 levels in dentinal fluid sampled from teeth with painful (irreversible) pulpitis will be compared to MMP-9 levels of teeth without clinical signs and symptoms. Moreover, the MMP-9 levels of teeth showing an painless pulpitis (teeth affected by a caries lesion) will be compared to a repeated sample of the same tooth collected after removal of the caries lesion.
Statistical analysis:
MMP-9 contents in the clinical samples will be determined against a standard curve (4-parameter logistic curve fit) obtained from the recombinant pro-MMP-9 standard dilution series. Values between groups will be compared by using Mann-Whitney U test, with the alpha-type error set at 0.05.
- Conditions
- Pulpitis
- Being tested
- Collection of dentinal fluid using a cellulose membrane
- Keywords
- Pulpitis, Biomarker, Diagnostic, Dentinal fluid
- Medical subject headings
- Pulpitis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of dentinal fluid using a cellulose membraneProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Pulp necrosis | Not described Receives: 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). Receives: Procedure: Collection of dentinal fluid using a cellulose membrane | |
| Irreversible pulpitis | Not described Receives: Procedure: Collection of dentinal fluid using a cellulose membrane | |
| Normal pulp | Not described Receives: Procedure: Collection of dentinal fluid using a cellulose membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total matrix metalloproteinase 9 (MMP-9) level in dentinal fluid
Measured: Immediately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startOct 2016
- Primary completion17 Oct 2017
- Study completion17 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PulpitisStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02967081
- Sponsor's protocol ID
- PB_2016-02043
- Status last verified
- May 2018
- First submitted
- 11 Nov 2016
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 21146069
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dentinal Fluid for the Presence of Matrix Metalloproteinase 9 (MMP-9) in Pulpal Inflammation
- ClinicalTrials.gov ID
- NCT02967081
- Acronym / sponsor ID
- PB_2016-02043
- Conditions
- Pulpitis
- Keywords
- Pulpitis, Biomarker, Diagnostic, Dentinal fluid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- 17 Oct 2017 (actual)
- Study completion
- 17 Oct 2017 (actual)
- First posted
- 17 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objective:
The aim of the study is to use an improved sampling method for collection of MMP-9 to test the hypothesis that MMP-9 levels are significantly elevated in the dentinal fluid of symptomatic (painful) human permanent teeth compared to asymptomatic counterparts that need replacement of a filling, and pulp necrotic teeth. Moreover, the dynamics of MMP-9 expression after removal of the causative stimulus for pulpitis is to be investigated.
Outcome:
Measuring the total MMP-9 levels of dentinal fluid collected during dental treatment using a human MMP-9 fluorescent assay.
Measurements and procedures:
Patients attending the day service of the Center of Dental Medicine Zurich will be screened. Patients matching the inclusion criteria will be asked to participate in the study. Upon written informed consent, the affected tooth gets anesthetized, isolated with rubber dam and receives one of the following treatment procedures: caries removal and restoration, tooth filling replacement and restoration, or root canal treatment (because of irreversible pulpitis, or pulp necrosis). After caries removal, removal of the defect tooth filling, or during access cavity preparation, a cellulose membrane (paper point) will be applied with its blunt end to the dentin for 1 min to collect dentinal fluid. The cellulose membrane will be stored until the laboratory analysis. Depending on the individual treatment plan of the patient, the tooth will subsequently receive root canal treatment, its final restoration, or a temporization with glass-ionomer cement for coverage of the dentinal wound and reinforcement of the remaining tooth structure. Final restoration of a tooth with composite, a partial crowns, or full-coverage crown can be technically demanding, time consuming, and frequently involves multiple patient visits. Teeth that receive root canal treatment, or the final restoration are sampled once. When a patient with a temporized tooth returns for the final restoration, the sampling procedure (appliance of a cellulose membrane to the dentin for 1 min and storage for further analyses) will be repeated. Any further treatment will be continued without further impairments. The investigation does not alter the treatment plan of any patient (either participating in one, or two sampling procedures, or in the study at all).
Number of participants:
Based on a previously performed study (Zehnder et al., 2011), which used a similar experimental set-up and had 31 participants (2 groups), it is aimed to recruit 60 participants for the current study.
Comparators:
MMP-9 levels in dentinal fluid sampled from teeth with painful (irreversible) pulpitis will be compared to MMP-9 levels of teeth without clinical signs and symptoms. Moreover, the MMP-9 levels of teeth showing an painless pulpitis (teeth affected by a caries lesion) will be compared to a repeated sample of the same tooth collected after removal of the caries lesion.
Statistical analysis:
MMP-9 contents in the clinical samples will be determined against a standard curve (4-parameter logistic curve fit) obtained from the recombinant pro-MMP-9 standard dilution series. Values between groups will be compared by using Mann-Whitney U test, with the alpha-type error set at 0.05.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 10 Days
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pulp necrosis | – | Procedure: Collection of dentinal fluid using a cellulose membrane |
| Pulpitis (painless) | – | Procedure: Collection of dentinal fluid using a cellulose membraneIn 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). |
| Irreversible pulpitis | – | Procedure: Collection of dentinal fluid using a cellulose membrane |
| Normal pulp | – | Procedure: Collection of dentinal fluid using a cellulose membrane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of dentinal fluid using a cellulose membraneAfter 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. | Procedure or surgery | Irreversible pulpitis, Normal pulp, Pulp necrosis, Pulpitis (painless) |
Primary outcome
Total matrix metalloproteinase 9 (MMP-9) level in dentinal fluid
Time frame: Immediately
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Background: PubMed 21146069Zehnder 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulpitis, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total matrix metalloproteinase 9 (MMP-9) level in dentinal fluid (time frame: Immediately). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02967081, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2018.