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Dental Pulp ExposureRetroMTANCT03631511

Histological Evaluation of Hard Tissue Formation After Direct Pulp Capping With RetroMTA

A study testing direct pulp capping with RetroMTA in people with Dental Pulp Exposure, run by Pomeranian Medical University Szczecin at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study presents a clinical and histological evaluation of human pulp tissue responses after direct capping using RetroMTA. Seven teeth were subjected to pulp exposure, direct capping with RetroMTA, and restoration with a composite resin. Seven months later, the teeth were clinically and radiographically evaluated. Read more about this study

Who is it for?
Ages 30 to 37 yearsHealthy volunteers can take part
Conditions the study is for
Dental Pulp Exposure
What is being tested?
direct pulp capping with RetroMTA
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 sitePoland
Study dates
3 Apr 2016to 18 Jun 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 30 to 37 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • The inclusion criteria were healthy patients with no contributing systemic conditions, who had at least one caries-free mature permanent third molar

Who cannot join

  • The exclusion criteria included patients who had pulp inflammation, pulp necrosis, root resorption or periapical diseases

Trial locations and contacts

1 site in 1 country.

Poland1 site
  • Pomeranian Medical University in Szczecin

    Szczecin, Rybacka 1, 70-111

Other trials in Poland

About this study

Official title: Histological Evaluation of Direct Pulp Capping on Human Pulp Tissue Using a RetroMTA

This study presents a clinical and histological evaluation of human pulp tissue responses after direct capping using RetroMTA. Seven teeth were subjected to pulp exposure, direct capping with RetroMTA, and restoration with a composite resin. Seven months later, the teeth were clinically and radiographically evaluated. The teeth were then extracted and subjected to histological processing and evaluation.

Read the detailed description

The study was conducted in accordance with the tenets of the World Medical Association Declaration of Helsinki. Seven caries-free, intact, maxillary, and mandibular third molars from humans, aged 30-37 years, which were scheduled for extraction for orthodontic or surgical purposes, were included in the study. The patients received a thorough explanation of the experimental rationale, clinical procedures, and possible complications. All experimental protocols were independently reviewed and approved by the Local Ethics Committee of Pomeranian Medical University, Szczecin, Poland (approval number KB-0012/27/13).

Clinical protocol. For all included teeth, periapical radiographs were taken to exclude the presence of caries or periapical pathology. Tooth sensitivity was assessed by thermal testing (Kältespray; M\&W Dental, Büdingen, Germany) and electric sensitivity testing (Vitality Scanner Pulp Vitality Tester; SybronEndo, Orange, CA, USA). These teeth were subjected to pulp exposure, direct capping with RetroMTA, and restoration with a composite resin. Seven months later, the teeth were clinically and radiographically evaluated. Clinical assessment was performed at 1 week and at 7 months after the procedure. During clinical interviews, the patients were asked about the presence of pain, and its type and duration. Reactions to thermal stimuli were classified into three categories: 1 = normal response (pain lasting up to 10 s); 2 = an extended response (pain > 10 s); 3 = no response. An electrical test was performed using a Vitality Scanner, and was repeated three times. Seven months after the procedure the teeth were extracted and subjected to histological processing and evaluation.

Histological processing. Immediately after extraction, the teeth were immersed in a 10% neutral buffered formalin solution, and gently washed from blood and saliva. After brief prefixation (≤10 minutes), special precautions were taken to facilitate pulp tissue fixation. The roots were separated 5 mm apically to the cemento-enamel junction, using a diamond disk under copious water cooling. Then the teeth were grinded with a high speed cylindrical diamond bur under water spray in a mesio-distal or bucco-lingual plane until exposing one or more pulp horns. Photographs and radiographs were taken of each sample before successive steps. For demineralization, the specimens were immersed for 3 to 4 weeks in an aqueous solution consisting of a mixture of 22.5% (v/v) formic acid and 10% (w/v) sodium citrate, with radiographic determination of the end-point. Then all specimens were washed in running tap water for 24 hours, dehydrated using ascending grades of ethanol, cleared in xylene, infiltrated, and embedded in paraffin (melting point of 56 °C) following standard procedures. The paraffin blocks were trimmed. With the microtome set at 5 μM, serial sections were taken until exhausting the entire pulp tissue in the chamber. Six to eight sections were collected on each slide. Every fifth slide was stained with haematoxylin and eosin for screening and evaluation of mineralized tissue formation. These stained sections were used to locate the areas exhibiting the most severe inflammatory reactions, and those with less favourable bridging. Based on this initial evaluation, all slides adjacent to the location with the less favourable conditions were stained. In addition, the selected slides were subjected to a modified Brown and Brenn technique (Taylor 1966) for staining bacteria. Next, cover slips were placed on the slides, and the sections were examined using a light microscope. For each pulp, the worst histologic condition observed was recorded. If bacteria were observed on the cavity walls or in the area of exposure, the case was excluded from evaluation.

Two intact teeth (one maxillary and one mandibular third molar) extracted for pericoronitis were used as control. To test the reliability of the bacterial stain, two teeth with deep caries were examined, extracted because deemed non-restorable. These teeth were processed using the same protocol as the experimental group.

Slides were observed under a light microscope (Leica DMLB; Leica Microsystems, Wetzlar, Germany) and digital photographs were taken (Leica DFC420; Leica Microsystems, Wetzlar, Germany). Following aspects were observed with particular care: 1) Presence and type of mineralized tissues formed in the area of the surgical exposure; 2) Morphology of cells layering this mineralized tissue; 3) Presence and degree of inflammatory reactions in the pulpal area subjacent to the newly formed tissue; and 4) Presence of stainable bacteria in the experimental cavity or the area of pulp exposure.

Being tested
direct pulp capping with RetroMTA
Keywords
direct pulp capping, RetroMTA, histological evaluation
Medical subject headings
Dental Pulp Exposure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • direct pulp capping with RetroMTAProcedure or surgery

    The study included seven caries-free third molars from three adults. These teeth were subjected to pulp exposure, direct capping with RetroMTA, and restoration with a composite resin. Seven months later, the teeth were clinically and radiographically evaluated. The teeth were then extracted and subjected to histological processing and evaluation.

Study groups in NCT03631511
Study groupRoleWhat they receive
RetroMTAExperimentalDirect pulp capping with RetroMTA (BioMTA, Daejeon, Korea)
Receives: Procedure: direct pulp capping with RetroMTA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Histological Evaluation of Direct Pulp Capping on Human Pulp Tissue Using a RetroMTA

    Each histomorphologic section was scored from 1-3, with 1 representing the most desired result and 3 representing the least desired result.

    Mineralized tissue bridge

    1. Complete
    2. Incomplete
    3. Absent

    Mineralized tissue morphology

    1. Dentin associated with irregular hard tissue
    2. Only irregular hard tissue deposition
    3. No hard tissue deposition

    Inflammatory response

    1. Absent
    2. Mild (inflammatory cells next to dentin bridge or area of pulp exposure only)
    3. Severe (all of the coronal pulp is infiltrated or necrotic)

    Odontoblastic cell layer

    1. Presence of odontoblast cells and odontoblast-like cells
    2. Presence of odontoblast-like cells only
    3. Absent

    Presence of bacteria

    1. Absence
    2. Presence of stained bacterial profiles along the coronal or apical walls
    3. Presence of stained bacterial profiles within the dental pulp

    Measured: 7 months

Secondary outcomes (1)
  1. Clinical Examination of Direct Pulp Capping on Human Pulp Tissue Using a RetroMTA

    Number of participants with adverse events related to RetroMTA treatment

    Periapical pathology

    1. absent
    2. present

    The presence of pain

    1. absent
    2. present

    Tooth sensitivity:

    1. Reactions to thermal stimuli
    2. present
    3. absent

    II. Electric sensitivity

    1. present
    2. absent

    1 representing the most desired result and 2 representing the least desired result.

    Measured: 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2018
  2. Study start3 Apr 2016
  3. Primary completion20 Mar 2017
  4. Study completion18 Jun 2018

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03631511
Sponsor's protocol ID
Direct capping RetroMTA
Acronym
RetroMTA
Status last verified
Aug 2018
First submitted
24 Jul 2018
Last updated
15 Aug 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Dammaschke T, Nowicka A, Lipski M, Ricucci D. Histological evaluation of hard tissue formation after direct pulp capping with a fast-setting mineral trioxide aggregate (RetroMTA) in humans. Clin Oral Investig. 2019 Dec;23(12):4289-4299. doi: 10.1007/s00784-019-02876-2. Epub 2019 Mar 12.

    PubMed 30864114

Questions about this trial

What is this clinical trial studying?

A study testing direct pulp capping with RetroMTA in people with Dental Pulp Exposure, run by Pomeranian Medical University Szczecin at 1 site in Poland.

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 1 inclusion and 1 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 15 Aug 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 Poland. 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?

Histological Evaluation of Direct Pulp Capping on Human Pulp Tissue Using a RetroMTA (time frame: 7 months). 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 NCT03631511, 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 15 Aug 2018.

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