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Assessment of Vital Pulp Therapy in Permanent Molars

Primary Purpose

Dental Caries Extending to Pulp, Pulp Disease, Dental

Status

Unknown status

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

NeoMTA

About this trial

This is an interventional treatment trial for Dental Caries Extending to Pulp focused on measuring Permanent teeth, Vital pulp therapy, MTA

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Hacettepe UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NeoMTA

Arm Description

Vital pulp therapy with NeoMTA

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03410134

First Posted

December 3, 2017

Last Updated

March 12, 2021

Sponsor

Hacettepe University

1. Study Identification

Unique Protocol Identification Number

NCT03410134

Brief Title

Assessment of Vital Pulp Therapy in Permanent Molars

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Unknown status

Study Start Date

November 1, 2017 (Actual)

Primary Completion Date

August 1, 2022 (Anticipated)

Study Completion Date

August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Caries Extending to Pulp, Pulp Disease, Dental

Keywords

Permanent teeth, Vital pulp therapy, MTA

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

NeoMTA

Arm Type

Experimental

Arm Description

Vital pulp therapy with NeoMTA

Intervention Type

Device

Intervention Name(s)

NeoMTA

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zafer C Cehreli, Prof

Phone

00905353197969

zcehreli@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Gizem E Unverdi

Phone

00905052805736

erbasgizem@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zafer C Cehreli, DDS,PhD

Organizational Affiliation

Hacettepe University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hacettepe University

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zafer C Cehreli, DDS, PhD

Phone

+903123052289

zcehreli@gmail.com

First Name & Middle Initial & Last Name & Degree

Beste Ozgur, DDS, PhD

Phone

+903123052280

besteisbitiren@yahoo.com

First Name & Middle Initial & Last Name & Degree

Zafer C Cehreli, DDS, PhD

First Name & Middle Initial & Last Name & Degree

Gizem Erbas Unverdi, DDS, PhD

First Name & Middle Initial & Last Name & Degree

Beste Ozgur, DDS, PhD

First Name & Middle Initial & Last Name & Degree

Atilla S Atac, DDS, PhD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

22431145

Citation

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.

Results Reference

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PubMed Identifier

26715408

Citation

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.

Results Reference

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PubMed Identifier

26841969

Citation

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.

Results Reference

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Assessment of Vital Pulp Therapy in Permanent Molars

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