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Assessment of Vital Pulp Therapy in Permanent Molars

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ClinicalTrials.gov Identifier: NCT03410134
Recruitment Status : Recruiting
First Posted : January 25, 2018
Last Update Posted : February 12, 2018
Information provided by (Responsible Party):
Zafer Cavit Cehreli, Hacettepe University

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

Condition or disease Intervention/treatment
Dental Caries Extending to Pulp Pulp Disease, Dental Device: NeoMTA

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  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Vital Pulp Therapy in Young Permanent Molars With Irreversible Pulpitis
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2021

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.

Primary Outcome Measures :
  1. 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).

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03410134

Contact: Zafer C Cehreli, Prof 00905353197969 zcehreli@gmail.com
Contact: Gizem E Unverdi 00905052805736 erbasgizem@yahoo.com

Hacettepe University Recruiting
Ankara, Turkey, 06100
Contact: Zafer C Cehreli, DDS, PhD    +903123052289    zcehreli@gmail.com   
Contact: Beste Ozgur, DDS, PhD    +903123052280    besteisbitiren@yahoo.com   
Principal Investigator: Zafer C Cehreli, DDS, PhD         
Sub-Investigator: Gizem Erbas Unverdi, DDS, PhD         
Sub-Investigator: Beste Ozgur, DDS, PhD         
Sub-Investigator: Atilla S Atac, DDS, PhD         
Sponsors and Collaborators
Hacettepe University
Principal Investigator: Zafer C Cehreli, DDS,PhD Hacettepe University

Responsible Party: Zafer Cavit Cehreli, Principal Investigator, Hacettepe University
ClinicalTrials.gov Identifier: NCT03410134     History of Changes
Other Study ID Numbers: Irreversible pulpitis
First Posted: January 25, 2018    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zafer Cavit Cehreli, Hacettepe University:
Permanent teeth
Vital pulp therapy

Additional relevant MeSH terms:
Dental Caries
Dental Pulp Diseases
Stomatognathic Diseases
Tooth Demineralization
Tooth Diseases