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Vital Pulp Therapy (VPT) Using Calcium Enriched Mixture (CEM) to Treat Irreversible Pulpitis

Primary Purpose

Irreversible Pulpitis

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Indirect pulp capping (IPC)
Direct pulp capping (DPC)
Miniature pulpotomy (MP)
Full pulpotomy (FP)
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irreversible Pulpitis focused on measuring Vital pulp therapy, Pulp cap, pulpotomy, calcium enriched mixture, CEM cement, Endodontic

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Moderate or severe periodontitis; pockets >3mm
  2. None restorable tooth
  3. Internal or external root resorption
  4. Root canal calcification
  5. Non vital pulps
  6. Analgesic taken within the last 8h
  7. Active systemic disease
  8. Pregnancy or nursing
  9. History of opioid addiction/abuse
  10. Temporary residency

Sites / Locations

  • Imam Khomeini Dental Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Indirect pulp capping (IPC)

Direct pulp capping (DPC)

Miniature pulpotomy (MP)

Full pulpotomy (FP)

Arm Description

Indirect pulp capping

Direct pulp capping

Miniature pulpotomy

Full pulpotomy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Patient Assessment of Pain with questionnaire
Pain assessment is carried out using the pain Numerical Rating Scale (NRS) with ratings between 0 to 9. Pain assessment is made up to 7 days. One NRS form is given to each patient to complete.

Full Information

First Posted
March 14, 2012
Last Updated
April 26, 2017
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01561183
Brief Title
Vital Pulp Therapy (VPT) Using Calcium Enriched Mixture (CEM) to Treat Irreversible Pulpitis
Official Title
Vital Pulp Therapy for Management of Irreversible Pulpitis in Human Permanent Teeth: A Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The purpose of this randomized clinical trial is to demonstrate the effect of four methods of Vital Pulp Therapy (VPT) using a new endodontic bio-material [calcium enriched mixture (CEM) cement] in pain relief as well as clinical/radiographic success, for management of irreversible pulpitis of human permanent teeth.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irreversible Pulpitis
Keywords
Vital pulp therapy, Pulp cap, pulpotomy, calcium enriched mixture, CEM cement, Endodontic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
302 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Indirect pulp capping (IPC)
Arm Type
Experimental
Arm Description
Indirect pulp capping
Arm Title
Direct pulp capping (DPC)
Arm Type
Experimental
Arm Description
Direct pulp capping
Arm Title
Miniature pulpotomy (MP)
Arm Type
Experimental
Arm Description
Miniature pulpotomy
Arm Title
Full pulpotomy (FP)
Arm Type
Experimental
Arm Description
Full pulpotomy
Intervention Type
Procedure
Intervention Name(s)
Indirect pulp capping (IPC)
Other Intervention Name(s)
Indirect pulp capping
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Direct pulp capping (DPC)
Other Intervention Name(s)
Direct pulp capping
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Miniature pulpotomy (MP)
Other Intervention Name(s)
Miniature pulpotomy
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Full pulpotomy (FP)
Other Intervention Name(s)
Full pulpotomy
Intervention Description
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
Primary Outcome Measure Information:
Title
Clinical and radiographical success rates (%) of each treatment group
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Patient Assessment of Pain with questionnaire
Description
Pain assessment is carried out using the pain Numerical Rating Scale (NRS) with ratings between 0 to 9. Pain assessment is made up to 7 days. One NRS form is given to each patient to complete.
Time Frame
6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Jafar Eghbal, DDS, MS
Organizational Affiliation
Iran Center For Dental Research
Official's Role
Study Director
Facility Information:
Facility Name
Imam Khomeini Dental Clinic
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
22137499
Citation
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.
Results Reference
background

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Vital Pulp Therapy (VPT) Using Calcium Enriched Mixture (CEM) to Treat Irreversible Pulpitis

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