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

Not Applicable

Completed

• Conditions: Irreversible Pulpitis
• Interventions: Procedure: Full pulpotomy (FP); Procedure: Direct pulp capping (DPC); Procedure: Indirect pulp capping (IPC); Procedure: Miniature pulpotomy (MP)

• Registration Number: NCT01561183
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-14
• Study First Submitted QC: 2012-03-21
• Study First Posted: 2012-03-22
• Primary Completion: 2014-03
• Study Completion: 2016-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-26
• Last Update Posted: 2017-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 302

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Full pulpotomy (FP)	Full pulpotomy (FP)	Full pulpotomy
Direct pulp capping (DPC)	Direct pulp capping (DPC)	Direct pulp capping
Indirect pulp capping (IPC)	Indirect pulp capping (IPC)	Indirect pulp capping
Miniature pulpotomy (MP)	Miniature pulpotomy (MP)	Miniature pulpotomy

Primary Outcome Measures

Name	Time	Method
Clinical and radiographical success rates (%) of each treatment group	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

Name	Time	Method
Patient Assessment of Pain with questionnaire	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.

Trial Locations

Locations (1)

Imam Khomeini Dental Clinic; 🇮🇷 Tehran, Iran, Islamic Republic of