MMP-9 Expression in Permanent Mature Teeth With Symptomatic Pulpitis

January 14, 2019 updated by: Eglė Gvazdaitytė

A Prospective Clinical Pilot Study of MMP-9 Expression and Short-term Outcome of Coronal Pulpotomy in Mature Permanent Teeth With Symptomatic Pulpitis

Matrix metallopeptidase-9 (MMP-9) expression was compared in healthy and inflamed pulp and the outcome of coronal pulpotomy in teeth with symptomatic pulpitis was assessed. After procedure blood samples were examined using Elisa kit.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Introduction: Widely used diagnostic tests do not provide information to distinguish the pulp inflammation stage while improvement of materials, techniques and vital pulp therapy have received a wider acceptance in symptomatic pulpitis treatment. The aim of this clinical study was to compare MMP-9 expression in healthy and inflamed pulp and to assess the short-term outcome of coronal pulpotomy in mature permanent teeth with symptomatic pulpitis.

Methods: Patients diagnosed with symptomatic pulpitis were included in this clinical study. Coronal pulpotomy was performed using calcium-silicate based material and blood samples were taken. Initial and postoperative pain was recorded by Heft-Parker visual analog scale at 24 hours and 72 hours after the procedure. In control group teeth with healthy pulp were used. During follow-up visits after three and six-months, patients were examined clinically and radiographically. The ELISA kit was used to determine the levels of MMP-9 in inflamed and healthy coronal pulp tissue.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lithuania
      • Kaunas, Lithuania
        • Lithuanian University of Health Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 33 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Teeth diagnosed with symptomatic pulpitis
  • Patients who did not use any NSAIDs before the treatment
  • Positive cold test of investigated teeth
  • Clinically dental caries in contact with pulp chamber
  • Permanent teeth with radiographically closed root apex

Exclusion Criteria:

  • Patients who refuse to participate in the study
  • Medically compromised patients (with immunosuppressive/systemic diseases, patients on medications)
  • Teeth with periapical radiolucency or clinical signs of apical periodontitis
  • Periodontological compromised teeth (probing depth ≥4mm)
  • Internal/external root resorption in periapical radiograph
  • Pulp chamber and/or root canal calcification in periapical radiograph
  • Teeth with unrestorable crown
  • Teeth with a negative response to cold test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Control group - Healthy teeth
Patients with clinically healthy third molar or premolar teeth with indications for extraction; no clinical signs of pulpitis, no caries, no indications for the replacement of an old filling that is 1 mm from the pulp space as determined on the radiograph; a normal response to the cold test, and no apical radiolucency on the radiograph. For teeth of this group coronal pulpotomy was applied.
Procedure: Coronal pulpotomy
Coronal pulpotomy was performed with a sterile high-speed round bur under water coolant. Pulp vitality was confirmed by the presence of bleeding pulp tissue from all of the canal orifices. Hemostasis was achieved through the application of a pellet moistened with 2.5% NaOCl for two minutes and was repeated as needed. Calcium-silicate based material was prepared ac-cording to the manufacturer's instructions and gently placed over the pulp to fill the entire cavity.
Experimental: Test group - Teeth with pulpitis
Patients with symptomatic pulpitis resulting from caries; tooth pain defined as sharp, dull, localized or diffuse; pain at night; a symptomatic tooth with a positive response to the cold test and lingering pain; intermittent or continuous episodes of spontaneous pain (with no external stimulus) that could last from a few minutes up to a few hours; no apical radiolucency on the radiograph. For teeth of this group coronal pulpotomy was applied.
Procedure: Coronal pulpotomy
Coronal pulpotomy was performed with a sterile high-speed round bur under water coolant. Pulp vitality was confirmed by the presence of bleeding pulp tissue from all of the canal orifices. Hemostasis was achieved through the application of a pellet moistened with 2.5% NaOCl for two minutes and was repeated as needed. Calcium-silicate based material was prepared ac-cording to the manufacturer's instructions and gently placed over the pulp to fill the entire cavity.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
MMP-9 amount measurement using ELISA kit
Time Frame: All samples were measured in one time (during 12 hours)
The MMP-9 amount in the pulp blood samples was measured using the MMP-9 Human ELISA Kit. The measurement procedure was followed according to the manufacturer's instructions. The anti-MMP-9 polyclonal antibody was pre-coated on 96-well plates. Blood samples and a biotin-conjugated antibody were added to the wells supplemented with Avidin-Biotin-Peroxidase Complex and 3,3',5,5'-tetramethylbenzidine in a mildly acidic buffer. A blue-colored product was produced and turned to yellow after an acidic stop solution was added. The intensity of the color yellow was proportional to the MMP-9 amount bound on the plate. The optical density absorbance was measured spectrophotometrically at 450nm in a microplate reader and the concentration of MMP-9 was calculated. For the expression of MMP-9 concentrations in the samples, a standard curve was used.
All samples were measured in one time (during 12 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eglė Gvazdaitytė

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Greta Lodiene, Lithuanian University of Health Science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 27, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 11, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 17, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BEC-LSMU(R)-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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