NCT03807674

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 27, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 17, 2019

Completed
Last Updated

January 17, 2019

Status Verified

January 1, 2019

Enrollment Period

4 months

First QC Date

November 19, 2018

Last Update Submit

January 14, 2019

Conditions

Pulpitis

Keywords

Calcium-silicate, coronal pulpotomy, MMP-9, symptomatic pulpitis.

Outcome Measures

Primary Outcomes (1)

  • 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.

    All samples were measured in one time (during 12 hours)

Study Arms (2)

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.

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.

Procedure: Coronal pulpotomy

Interventions

Coronal pulpotomyPROCEDURE

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.

Control group - Healthy teethTest group - Teeth with pulpitis

Eligibility Criteria

Age14 Years - 33 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lithuanian University of Health Science

Kaunas, Lithuania

Location

MeSH Terms

Conditions

Pulpitis

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Study Officials

  • Greta Lodiene

    Lithuanian University of Health Science

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
The senior resident of Lithuanian University of Health Sciences

Study Record Dates

First Submitted

November 19, 2018

First Posted

January 17, 2019

Study Start

March 27, 2017

Primary Completion

July 15, 2017

Study Completion

February 11, 2018

Last Updated

January 17, 2019

Record last verified: 2019-01

Locations

LI(1)