NCT03410134

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 3, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 25, 2018

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

March 15, 2021

Status Verified

March 1, 2021

Enrollment Period

4.8 years

First QC Date

December 3, 2017

Last Update Submit

March 12, 2021

Conditions

Dental Caries Extending to PulpPulp Disease, Dental

Keywords

Permanent teethVital pulp therapyMTA

Outcome Measures

Primary Outcomes (1)

  • Clinical evaluation of vital pulp therapy in permanent teeth with irreversible pulpitis

    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

Study Arms (1)

NeoMTA

EXPERIMENTAL

Vital pulp therapy with NeoMTA

Device: NeoMTA

Interventions

NeoMTADEVICE

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.

NeoMTA

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Asgary S, Eghbal MJ, Ghoddusi J, Yazdani S. One-year results of vital pulp therapy in permanent molars with irreversible pulpitis: an ongoing multicenter, randomized, non-inferiority clinical trial. Clin Oral Investig. 2013 Mar;17(2):431-9. doi: 10.1007/s00784-012-0712-6. Epub 2012 Mar 21.

    PMID: 22431145BACKGROUND

  • Taha NA, Ahmad MB, Ghanim A. Assessment of Mineral Trioxide Aggregate pulpotomy in mature permanent teeth with carious exposures. Int Endod J. 2017 Feb;50(2):117-125. doi: 10.1111/iej.12605. Epub 2016 Jan 30.

    PMID: 26715408BACKGROUND

  • Qudeimat MA, Alyahya A, Hasan AA. Mineral trioxide aggregate pulpotomy for permanent molars with clinical signs indicative of irreversible pulpitis: a preliminary study. Int Endod J. 2017 Feb;50(2):126-134. doi: 10.1111/iej.12614. Epub 2016 Feb 22.

    PMID: 26841969BACKGROUND

MeSH Terms

Conditions

Dental Pulp Diseases

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Zafer C Cehreli, DDS,PhD

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zafer C Cehreli, Prof

CONTACT

00905353197969zcehreli@gmail.com

Gizem E Unverdi

CONTACT

00905052805736erbasgizem@yahoo.com

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
Principal Investigator

Study Record Dates

First Submitted

December 3, 2017

First Posted

January 25, 2018

Study Start

November 1, 2017

Primary Completion

August 1, 2022

Study Completion

August 1, 2023

Last Updated

March 15, 2021

Record last verified: 2021-03

Locations

TU(1)