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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Imamkhomeini dental clinic
Information provided by (Responsible Party):
Saeed Asgary, Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT01561183
First received: March 14, 2012
Last updated: March 21, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention Phase
Irreversible Pulpitis
Procedure: Indirect pulp capping (IPC)
Procedure: Direct pulp capping (DPC)
Procedure: Miniature pulpotomy (MP)
Procedure: Full pulpotomy (FP)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Vital Pulp Therapy for Management of Irreversible Pulpitis in Human Permanent Teeth: A Randomized Clinical Trial.

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti Medical University:

Primary Outcome Measures:
  • Clinical and radiographical success rates (%) of each treatment group [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: March 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Indirect pulp capping (IPC)
Indirect pulp capping
Procedure: Indirect pulp capping (IPC)

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
Other Name: Indirect pulp capping
Experimental: Direct pulp capping (DPC)
Direct pulp capping
Procedure: Direct pulp capping (DPC)

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
Other Name: Direct pulp capping
Experimental: Miniature pulpotomy (MP)
Miniature pulpotomy
Procedure: Miniature pulpotomy (MP)

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
Other Name: Miniature pulpotomy
Experimental: Full pulpotomy (FP)
Full pulpotomy
Procedure: Full pulpotomy (FP)

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
Other Name: Full pulpotomy

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.

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01561183

Locations
Iran, Islamic Republic of
Imam Khomeini Dental Clinic
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Shahid Beheshti Medical University
Imamkhomeini dental clinic
Investigators
Study Director: Mohammad Jafar Eghbal, DDS, MS Iran Center For Dental Research
  More Information

Publications:
Responsible Party: Saeed Asgary, Dean of ICER, Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier: NCT01561183     History of Changes
Other Study ID Numbers: IKHDC: 01-11-1390
Study First Received: March 14, 2012
Last Updated: March 21, 2012
Health Authority: Iran: Ethics Committee

Keywords provided by Shahid Beheshti Medical University:
Vital pulp therapy
Pulp cap
pulpotomy
calcium enriched mixture
CEM cement
Endodontic

Additional relevant MeSH terms:
Pulpitis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 22, 2014