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

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ClinicalTrials.gov Identifier: NCT01561183
Recruitment Status : Completed
First Posted : March 22, 2012
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
Saeed Asgary, Shahid Beheshti University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Irreversible Pulpitis Procedure: Indirect pulp capping (IPC) Procedure: Direct pulp capping (DPC) Procedure: Miniature pulpotomy (MP) Procedure: Full pulpotomy (FP) Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 302 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Vital Pulp Therapy for Management of Irreversible Pulpitis in Human Permanent Teeth: A Randomized Clinical Trial.
Study Start Date : March 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Clinical and radiographical success rates (%) of each treatment group [ Time Frame: 1 year ]

    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 :
  1. Patient Assessment of Pain with questionnaire [ Time Frame: 6-months ]
    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.



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Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01561183


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

Publications:
Responsible Party: Saeed Asgary, Dean of ICER, Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01561183     History of Changes
Other Study ID Numbers: IKHDC: 01-11-1390
First Posted: March 22, 2012    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017

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

Additional relevant MeSH terms:
Pulpitis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs