Assessment of Vital Pulp Therapy in Permanent Molars

March 12, 2021 updated by: Zafer Cavit Cehreli, DDS, PhD, Hacettepe University

Clinical Evaluation of Vital Pulp Therapy in Young Permanent Molars With Irreversible Pulpitis

The purpose of this study is to evaluate the long term clinical performance of vital pulp therapy of young permanent teeth with irreversible pulpitis

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Permanent molar teeth meeting the inclusion criteria will be included into the study. Following local anaesthesia and dental dam application, caries excavation will be performed; and after exposure, the pulp will be amputated to the level of the canal orifices (full pulpotomy) using a sterile high-speed round bur under water coolant. After haemostasis is achieved, Mineral trioxide aggregate (MTA) will be gently placed over the pulp to a thickness of 2-3 mm and the tooth will be restored using glass ionomer cement and composite resin. A postoperative periapical radiograph will be taken. Patients will be reviewed at 6., 12., 24. and 36. months for clinical and radiographical success. The data will be analysed statistically using chi square test.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • 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 Contact

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Recruiting
        • Hacettepe University
        • Contact:
        • Sub-Investigator:
          • Beste Ozgur, DDS, PhD
        • Sub-Investigator:
          • Atilla S Atac, DDS, PhD

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

Ages Eligible for Study

6 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients and parents of the patients who accept to participate and sign the informed consent
  • Patients who have at least one vital permanent molar teeth with irreversible pulpitis symptoms
  • Teeth which can be restorable after the treatment.
  • Teeth which has good periodontal health and in the absence of sinus tracts or swelling.

Exclusion Criteria:

  • Patients and parents of the patients who does not accept to participate and sign the informed consent
  • Teeth which have dentoalveolar or extraoral swelling
  • Teeth which have periodontal disease, mobility or alveolar bone loss
  • Teeth which are not restorable
  • Patients who are not cooperative with the treatment

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: NeoMTA
Vital pulp therapy with NeoMTA
Device: NeoMTA
NeoMTA™ Plus® root and pulp treatment material is a powder/gel system with no resin. The components are an extremely fine powder primarily tricalcium and dicalcium silicate plus a water-based gel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical evaluation of vital pulp therapy in permanent teeth with irreversible pulpitis
Time Frame: 3 years

Long-term success of vital pulp therapy in young permanent teeth with irreversible pulpitis. Evaluation criteria will be;

  1. spontaneous pain (absent/present);
  2. tenderness to percussion/palpation (absent/present);
  3. mobility (no mobility/ 1mm/ 2mm/ 3mm mobility)
  4. swelling (absent/present);
  5. fistula (absent/present)
  6. periapical/interradicular radiolucency (absent/present);
  7. widened periodontal ligament (absent/present);
  8. loss of lamina dura (absent/present);
  9. internal/external root resorption (absent/present).
3 years

Collaborators and Investigators

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

Sponsor

Hacettepe University

Investigators

  • Principal Investigator: Zafer C Cehreli, DDS,PhD, Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 1, 2017

Primary Completion (ANTICIPATED)

August 1, 2022

Study Completion (ANTICIPATED)

August 1, 2023

Study Registration Dates

First Submitted

December 3, 2017

First Submitted That Met QC Criteria

January 24, 2018

First Posted (ACTUAL)

January 25, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 15, 2021

Last Update Submitted That Met QC Criteria

March 12, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Irreversible pulpitis

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

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.

Clinical Trials on Pulp Disease, Dental

Clinical Trials on NeoMTA

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe