NCT03631511

Brief 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. The teeth were then extracted and subjected to histological processing and evaluation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2017

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 24, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
Last Updated

August 15, 2018

Status Verified

August 1, 2018

Enrollment Period

12 months

First QC Date

July 24, 2018

Last Update Submit

August 10, 2018

Conditions

Dental Pulp Exposure

Keywords

direct pulp capping, RetroMTA, histological evaluation

Outcome Measures

Primary Outcomes (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

    7 months

Secondary Outcomes (1)

  • Clinical Examination of Direct Pulp Capping on Human Pulp Tissue Using a RetroMTA

    7 months

Study Arms (1)

RetroMTA

EXPERIMENTAL

Direct pulp capping with RetroMTA (BioMTA, Daejeon, Korea)

Procedure: direct pulp capping with RetroMTA

Interventions

direct pulp capping with RetroMTAPROCEDURE

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.

RetroMTA

Eligibility Criteria

Age30 Years - 37 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pomeranian Medical University in Szczecin

Szczecin, Rybacka 1, 70-111, Poland

Location

Related Publications (1)

  • 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.

    PMID: 30864114DERIVED

MeSH Terms

Conditions

Dental Pulp Exposure

Interventions

mineral trioxide aggregate

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Study Officials

  • Alicja Nowicka, DDS, PhD

    Department of Conservative Dentistry and Endodontics, Pomeranian Medical University, Al. Powstańców Wielkopolskich 72, 70-111, Szczecin, Poland

    STUDY DIRECTOR

  • Till Dammaschke, DDS, PhD

    Department of Periodontology and Operative Dentistry, Westphalian Wilhelms-University, Albert-Schweitzer-Campus 1, building W 30, 48149 Münster, Germany

    STUDY CHAIR

  • Mariusz Lipski, DDS, PhD

    Department of Preclinical Conservative Dentistry and Preclinical Endodontics, Pomeranian Medical University, Al. Powstańców Wielkopolskich 72, 70-111, Szczecin, Poland

    STUDY CHAIR

  • Domenico Ricucci, MD, DDS

    Private Practice, Piazza Calvario, 7, 87022 Cetraro (CS), Italy

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS, PhD Alicja Nowicka

Study Record Dates

First Submitted

July 24, 2018

First Posted

August 15, 2018

Study Start

April 3, 2016

Primary Completion

March 20, 2017

Study Completion

June 18, 2018

Last Updated

August 15, 2018

Record last verified: 2018-08

Locations

PL(1)