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OpenTrials
Completed

NCT Number: NCT00748280

Vital Pulp Therapy to Treat Irreversible Pulpitis

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.

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Key information

Age range

9 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Iranian Center for Endodontic research

Tehran, 19839, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnostic criteria:
  • Patient reports pain of endodontic origin
  • Diagnosis of irreversible pulpitis
  • Eligibility criteria:
  • Molar tooth
  • Patient chooses to have tooth extraction for pain relief
  • Age 9-65 years
  • Both gender
  • The patient had read and thoroughly understood the questionnaires; and
  • Written informed consent
  • Exclusion Criteria:
  • Moderate or severe periodontitis
  • None restorable tooth
  • Internal or external root resorption
  • Root canal calcification
  • No bleeding after access cavity preparation
  • Analgesic taken within the last 4 h
  • Active systemic disease
  • The patient was pregnant or nursing
  • History of opioid addiction or abuse
  • Temporary residency

Treatment and study plan

One-visit root canal therapy

Procedure

Teeth were isolated, caries was removed and access cavities were prepared. Canal preparation was conducted using step-back technique. The working lengths were determined and confirmed by radiographs. The minimum size file for preparing the working length was size ISO #25 K-file to within 0.5-2 mm of the radiographic apex of the root. During hand instrumentation, canals were frequently irrigated with adequate amount of sterile normal saline solution. The root canals were filled with multiple gutta-percha cones and sealer using lateral condensation technique. Placing a cotton pellet in the pulp chamber, the access cavity was temporarily filled. The treatments of all samples were performed one-visit.

Other names: single-visit RCT

Pulpotomy

Procedure

Pulpotomy was performed with a large round bur in a high-speed handpiece with copious irrigation; removing inflamed pulp tissue to stump level. Hemostasis was achieved by irrigation of the cavity with sterile normal saline and application of small pieces of sterile cotton pellets. The blood clot-free pulpal wound was covered with approximately 2 mm layer of endodontic bio-materials, a sterile wet cotton pellet was then placed over the MTA/CEM cement and the cavity sealed with Cavit.

Primary outcomes

  1. Clinical and radiographical success of pulpotomy with CEM cement

    Time frame: 5 year

Secondary outcomes

  1. Patient Assessment of Pain - Visual Analogue Scale

    Time frame: 7 day

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Official study title

Pulpotomy Versus Root Canal Therapy to Treat Irreversible Pulpitis in Human Permanent Molars: A Multicenter Randomized Non-inferiority Trial.

Acronym: VPT

Important dates

Study start
2008
Primary completion
2008
Study completion
2016
First posted
Sep 8, 2008
Registry last updated
Apr 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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