NCT01561183

Brief Summary

To compare the effect of different VPT methods using Calcium Enriched Mixture (CEM) cement for management of human dental pulp with irreversible pulpitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
302

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2012

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 22, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 28, 2017

Status Verified

April 1, 2017

Enrollment Period

2 years

First QC Date

March 14, 2012

Last Update Submit

April 26, 2017

Conditions

Irreversible Pulpitis

Keywords

Vital pulp therapyPulp cappulpotomycalcium enriched mixtureCEM cementEndodontic

Outcome Measures

Primary Outcomes (1)

  • Clinical and radiographical success rates (%) of each treatment group

    The outcome of clinical success/failure is determined by subjective symptoms and objective observation of inflammation/infection. The outcome of radiographic success is classified by using a modification of the Strindberg criteria.

    1 year

Secondary Outcomes (1)

  • Patient Assessment of Pain with questionnaire

    6-months

Study Arms (4)

Indirect pulp capping (IPC)

EXPERIMENTAL

Indirect pulp capping

Procedure: Indirect pulp capping (IPC)

Direct pulp capping (DPC)

EXPERIMENTAL

Direct pulp capping

Procedure: Direct pulp capping (DPC)

Miniature pulpotomy (MP)

EXPERIMENTAL

Miniature pulpotomy

Procedure: Miniature pulpotomy (MP)

Full pulpotomy (FP)

EXPERIMENTAL

Full pulpotomy

Procedure: Full pulpotomy (FP)

Interventions

Indirect pulp capping (IPC)PROCEDURE

Procedure: IPC The IPC will be performed as follow: * Anesthesia * isolation the tooth * access to the lesion * incomplete removal of carious tissue from the cavity walls * indirect pulp capping with ≈2 mm layer calcium enriched mixture cement * permanent filling with sandwich technique

Also known as: Indirect pulp capping
Indirect pulp capping (IPC)
Direct pulp capping (DPC)PROCEDURE

Procedure: DPC The DPC will be performed as follow: * Anesthesia * isolation the tooth * access to the lesion * complete removal of carious tissue from the cavity walls result in pulp exposure * preparation of clot-free pulpal mound * direct pulp capping with ≈2 mm layer calcium enriched mixture cement * permanent filling with sandwich technique

Also known as: Direct pulp capping
Direct pulp capping (DPC)
Miniature pulpotomy (MP)PROCEDURE

Procedure: MP The MP will be performed as follow: * Anesthesia * isolation the tooth * access to the lesion * complete removal of carious tissue from the cavity walls result in pulp exposure * intentionally removal of pulp horn (≈1 mm) * preparation of clot-free pulpal mound * direct pulp capping with ≈2 mm layer calcium enriched mixture cement * permanent filling with sandwich technique

Also known as: Miniature pulpotomy
Miniature pulpotomy (MP)
Full pulpotomy (FP)PROCEDURE

Procedure: FP The FP will be performed as follow: * Anesthesia * isolation the tooth * access to the lesion * complete removal of carious tissue from the cavity walls result in pulp exposure * pulpotomy * preparation of clot-free pulpal mound * direct pulp capping with ≈2 mm layer calcium enriched mixture cement * permanent filling with sandwich technique

Also known as: Full pulpotomy
Full pulpotomy (FP)

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Carious permanent vital mature molar tooth with closed apex (with preoperative X-ray)
  • Positive response to EPT or cold test
  • patients willing to participate in study
  • Healthy subjects; absence of any systematic disorder
  • Age ≥ 10 years old
  • Both gender
  • Written informed consent

You may not qualify if:

  • Moderate or severe periodontitis; pockets \>3mm
  • None restorable tooth
  • Internal or external root resorption
  • Root canal calcification
  • Non vital pulps
  • Analgesic taken within the last 8h
  • Active systemic disease
  • Pregnancy or nursing
  • History of opioid addiction/abuse
  • Temporary residency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imam Khomeini Dental Clinic

Tehran, Iran

Location

Related Publications (1)

  • Asgary S, Ahmadyar M. Can miniature pulpotomy procedure improve treatment outcomes of direct pulp capping? Med Hypotheses. 2012 Feb;78(2):283-5. doi: 10.1016/j.mehy.2011.11.002. Epub 2011 Dec 1.

    PMID: 22137499BACKGROUND

Study Officials

  • Mohammad Jafar Eghbal, DDS, MS

    Iran Center For Dental Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dean of ICER

Study Record Dates

First Submitted

March 14, 2012

First Posted

March 22, 2012

Study Start

March 1, 2012

Primary Completion

March 1, 2014

Study Completion

December 1, 2016

Last Updated

April 28, 2017

Record last verified: 2017-04

Locations

IR(1)