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NCT Number: NCT01561183

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

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

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Key information

Conditions

Irreversible Pulpitis

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imam Khomeini Dental Clinic

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Carious permanent vital mature molar tooth with closed apex (with preoperative X-ray)
  • Positive response to EPT or cold test
  • patients willing to participate in study
  • Healthy subjects; absence of any systematic disorder
  • Age ≥ 10 years old
  • Both gender
  • Written informed consent

Exclusion criteria

  • Moderate or severe periodontitis; pockets >3mm
  • None restorable tooth
  • Internal or external root resorption
  • Root canal calcification
  • Non vital pulps
  • Analgesic taken within the last 8h
  • Active systemic disease
  • Pregnancy or nursing
  • History of opioid addiction/abuse
  • Temporary residency

Treatment and study plan

Indirect pulp capping (IPC)

Procedure

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

Direct pulp capping (DPC)

Procedure

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

Miniature pulpotomy (MP)

Procedure

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

Full pulpotomy (FP)

Procedure

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2016
First posted
Mar 22, 2012
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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