NCT00748280

Brief Summary

The purpose of this study is to demonstrate non-inferiority of pulpotomy treatment (with new endodontic bio-materials) as a new treatment with one-visit root canal therapy as reference treatment in pain relief and clinical and radiographic success, for irreversible pulpitis of human permanent molar teeth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
615

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 8, 2008

Completed
8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

April 28, 2017

Status Verified

April 1, 2017

Enrollment Period

5 months

First QC Date

September 4, 2008

Last Update Submit

April 26, 2017

Conditions

Pulpitis

Keywords

EndodonticsCEM cementCalcium enriched mixtureMTARoot Canal TherapyPainPulpotomyHumanPermanentMolar teeth

Outcome Measures

Primary Outcomes (1)

  • Clinical and radiographical success of pulpotomy with CEM cement

    5 year

Secondary Outcomes (1)

  • Patient Assessment of Pain - Visual Analogue Scale

    7 day

Study Arms (2)

1

EXPERIMENTAL

ORCT

Procedure: One-visit root canal therapy

2

EXPERIMENTAL

PCEM/PMTA

Procedure: pulpotomy

Interventions

One-visit root canal therapyPROCEDURE

Teeth were isolated, caries was removed and access cavities were prepared. Canal preparation was conducted using step-back technique. The working lengths were determined and confirmed by radiographs. The minimum size file for preparing the working length was size ISO #25 K-file to within 0.5-2 mm of the radiographic apex of the root. During hand instrumentation, canals were frequently irrigated with adequate amount of sterile normal saline solution. The root canals were filled with multiple gutta-percha cones and sealer using lateral condensation technique. Placing a cotton pellet in the pulp chamber, the access cavity was temporarily filled. The treatments of all samples were performed one-visit.

Also known as: single-visit RCT
1
pulpotomyPROCEDURE

Pulpotomy was performed with a large round bur in a high-speed handpiece with copious irrigation; removing inflamed pulp tissue to stump level. Hemostasis was achieved by irrigation of the cavity with sterile normal saline and application of small pieces of sterile cotton pellets. The blood clot-free pulpal wound was covered with approximately 2 mm layer of endodontic bio-materials, a sterile wet cotton pellet was then placed over the MTA/CEM cement and the cavity sealed with Cavit.

2

Eligibility Criteria

Age9 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnostic criteria:
  • Patient reports pain of endodontic origin
  • Diagnosis of irreversible pulpitis
  • Eligibility criteria:
  • Molar tooth
  • Patient chooses to have tooth extraction for pain relief
  • Age 9-65 years
  • Both gender
  • The patient had read and thoroughly understood the questionnaires; and
  • Written informed consent

You may not qualify if:

  • Moderate or severe periodontitis
  • None restorable tooth
  • Internal or external root resorption
  • Root canal calcification
  • No bleeding after access cavity preparation
  • Analgesic taken within the last 4 h
  • Active systemic disease
  • The patient was pregnant or nursing
  • History of opioid addiction or abuse
  • Temporary residency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iranian Center for Endodontic research

Tehran, 19839, Iran

Location

MeSH Terms

Conditions

PulpitisPain

Interventions

Pulpotomy

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EndodonticsDentistry

Study Officials

  • Mohammad Jafar Eghbal, Prof.

    Shahid Beheshti University of Medical Sciences

    STUDY DIRECTOR

  • Jamileh Ghoddusi, Prof.

    Mashhad University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dean, Iranian Center foe Endodontic Research

Study Record Dates

First Submitted

September 4, 2008

First Posted

September 8, 2008

Study Start

April 1, 2008

Primary Completion

September 1, 2008

Study Completion

September 1, 2016

Last Updated

April 28, 2017

Record last verified: 2017-04

Locations

IR(1)