PulpitisNCT03807674
MMP-9 Expression in Permanent Mature Teeth With Symptomatic Pulpitis
A study testing Coronal pulpotomy in people with Pulpitis, run by Eglė Gvazdaitytė at 1 site in Lithuania.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 33 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis
- What is being tested?
- Coronal pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteLithuania
- Study dates
- 27 Mar 2017to 11 Feb 2018
- Phase
- Interventional
- 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 14 to 33 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pulpitis
- Being tested
- Coronal pulpotomy
- Keywords
- Calcium-silicate, coronal pulpotomy, MMP-9, symptomatic pulpitis.
- Medical subject headings
- Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronal pulpotomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group - Healthy teeth | Other | 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. Receives: Procedure: Coronal pulpotomy |
| Test group - Teeth with pulpitis | Experimental | 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. Receives: Procedure: Coronal pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMP-9 amount measurement using ELISA kit
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.
Measured: All samples were measured in one time (during 12 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start27 Mar 2017
- Primary completion15 Jul 2017
- Study completion11 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PulpitisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eglė Gvazdaitytė
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eglė Gvazdaitytė, Lithuanian University of Health Sciences
- Investigators
- Greta Lodiene, Study director, Lithuanian University of Health Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807674
- Sponsor's protocol ID
- BEC-LSMU(R)-01
- Status last verified
- Jan 2019
- First submitted
- 19 Nov 2018
- Last updated
- 17 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Pilot Study of MMP-9 Expression and Short-term Outcome of Coronal Pulpotomy in Mature Permanent Teeth With Symptomatic Pulpitis
- ClinicalTrials.gov ID
- NCT03807674
- Acronym / sponsor ID
- BEC-LSMU(R)-01
- Conditions
- Pulpitis
- Keywords
- Calcium-silicate, coronal pulpotomy, MMP-9, symptomatic pulpitis.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Eglė GvazdaitytėUniversity, hospital or other
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 15 Jul 2017 (actual)
- Study completion
- 11 Feb 2018 (actual)
- First posted
- 17 Jan 2019 (actual)
- 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group - Healthy teeth | Other | Procedure: Coronal pulpotomyPatients 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. |
| Test group - Teeth with pulpitis | Experimental | Procedure: Coronal pulpotomyPatients 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. |
Who may qualify
- Ages
- 14 to 33 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Coronal pulpotomyCoronal 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. | Procedure or surgery | Control group - Healthy teeth, Test group - Teeth with pulpitis |
Primary outcome
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.
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 17 Jan 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Pulpitis
Not yet recruiting
Anesthetic Effectiveness of Mental/Incisive Nerve Block Versus Inferior Nerve Block Using 4% Articaine and 2% Lidocaine in Mandibular First and Second Premolars With Symptomatic Irreversible Pulpitis.
Pain
Recruiting
Comparison of Anesthetic Efficacy OF 2% Lidocaine Inferior Alveolar Nerve (IANB) Block Versus Primary Buccal Infilteration With 4% Articaine in Symptomatic Irreversible Pulpitis(SIP) IN Mandibular First Molars
Anesthetic Efficacy
Recruiting
Clinical and Radiographic Evaluation of E-IodoCal in Primary Molar Pulpectomy
Pulpectomy, Pulpitis - Irreversible
Recruiting
Child's Behavior Using Single Rotary File System Versus Manual Instrumentation in Pulpectomy of Primary Molars
Irreversible Pulpitis
Not yet recruiting
Comparison of Postoperative Pain After Root Canal Treatment Using Hand-Held vs Rotary ProTaper Files: A Randomized Controlled Trial
Symptomatic Irreversible Pulpitis (SIP), Symptomatic Apical Periodontitis
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.
Greta Lodiene study director
Lithuanian University of Health Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronal pulpotomy in people with Pulpitis, run by Eglė Gvazdaitytė at 1 site in Lithuania.
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 8 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 17 Jan 2019. 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 Lithuania. 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?
MMP-9 amount measurement using ELISA kit (time frame: All samples were measured in one time (during 12 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jan 2019.