Vital Pulp Therapy to Treat Irreversible Pulpitis

Not Applicable

Completed

• Conditions: Pulpitis
• Interventions: Procedure: pulpotomy; Procedure: One-visit root canal therapy

• Registration Number: NCT00748280
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

The purpose of this study is to demonstrate non-inferiority of pulpotomy treatment (with new endodontic bio-materials) as a new treatment with one-visit root canal therapy as reference treatment in pain relief and clinical and radiographic success, for irreversible pulpitis of human permanent molar teeth.

Detailed Description

In one visit RCT (Arm 1): The teeth were anesthetized, isolated and endodontic access and instrumentation of all canals was done. Canal preparation was conducted using a step-back technique. The working lengths were determined and confirmed by radiography. Sterile normal saline solution was used for intra-canal irrigation. Root canals were obturated with gutta-percha and sealer using lateral condensation technique. After placing a cotton pellet in the pulp chamber, the access cavity was closed with Cavit.

In pulpotomy treatment with CEM/MTA (Arm 2): The teeth were anesthetized. Pulpotomy procedure of removing inflamed pulp tissue to the stump level was done. Homeostasis was achieved by irrigating the cavity with sterile normal saline and application of small pieces of sterile cotton pellets. The pulpal wound was covered with an approximately 2-mm-thick layer of MTA/CEM cement. Pulp chambers were then covered with a wet cotton pellet and sealed with Cavit.

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2008-09
• Study First Submitted: 2008-09-04
• Study First Submitted QC: 2008-09-04
• Study First Posted: 2008-09-08
• Study Completion: 2016-09
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-26
• Last Update Posted: 2017-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 615

Inclusion Criteria

• Diagnostic criteria:

  1. Patient reports pain of endodontic origin
  2. Diagnosis of irreversible pulpitis

• Eligibility criteria:

  1. Molar tooth
  2. Patient chooses to have tooth extraction for pain relief
  3. Age 9-65 years
  4. Both gender
  5. The patient had read and thoroughly understood the questionnaires; and
  6. Written informed consent

Exclusion Criteria

1. Moderate or severe periodontitis
2. None restorable tooth
3. Internal or external root resorption
4. Root canal calcification
5. No bleeding after access cavity preparation
6. Analgesic taken within the last 4 h
7. Active systemic disease
8. The patient was pregnant or nursing
9. History of opioid addiction or abuse
10. Temporary residency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	pulpotomy	PCEM/PMTA
1	One-visit root canal therapy	ORCT

Primary Outcome Measures

Name	Time	Method
Clinical and radiographical success of pulpotomy with CEM cement	5 year

Secondary Outcome Measures

Name	Time	Method
Patient Assessment of Pain - Visual Analogue Scale	7 day

Trial Locations

Locations (1)

Iranian Center for Endodontic research; 🇮🇷 Tehran, Iran, Islamic Republic of