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

Vital Pulp Therapy for Management of Irreversible Pulpitis in Human Permanent Teeth: A Randomized Clinical Trial.

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

Study Overview

• Status: Completed
• Conditions: Irreversible Pulpitis
• Intervention / Treatment: Procedure: Indirect pulp capping (IPC); Procedure: Direct pulp capping (DPC); Procedure: Miniature pulpotomy (MP); Procedure: Full pulpotomy (FP)

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
• Enrollment (Actual): 302
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Imam Khomeini Dental Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: 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 Names: Full pulpotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6-months

Collaborators and Investigators

• Sponsor: Shahid Beheshti University of Medical Sciences
• Investigators: Study Director: Mohammad Jafar Eghbal, DDS, MS, Iran Center For Dental Research

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): December 1, 2016

Study Registration Dates

• First Submitted: March 14, 2012
• First Submitted That Met QC Criteria: March 21, 2012
• First Posted (ESTIMATE): March 22, 2012

Study Record Updates

• Last Update Posted (ACTUAL): April 28, 2017
• Last Update Submitted That Met QC Criteria: April 26, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: pulpotomy; Vital pulp therapy; Endodontic; Pulp cap; calcium enriched mixture; CEM cement
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis
• Other Study ID Numbers: IKHDC: 01-11-1390