Assessment of Vital Pulp Therapy in Permanent Molars

Sponsor
Hacettepe University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03410134
Collaborator
(none)
300
1
1
69
4.4

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Device: NeoMTA
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
N/A
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 :
Nov 1, 2017
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Clinical evaluation of vital pulp therapy in permanent teeth with irreversible pulpitis [3 years]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 18 Years
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hacettepe University Ankara Turkey 06100

Sponsors and Collaborators

  • Hacettepe University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Zafer Cavit Cehreli, DDS, PhD, Principal Investigator, Hacettepe University
ClinicalTrials.gov Identifier:
NCT03410134
Other Study ID Numbers:
  • Irreversible pulpitis
First Posted:
Jan 25, 2018
Last Update Posted:
Mar 15, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
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, DDS, PhD, Principal Investigator, Hacettepe University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 15, 2021