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NCT Number: NCT01827098

A Clinical Study to Compare Two Revascularization Protocols to Treat Non-vital Teeth With Incomplete Root Formation

Both methods tested in this study disinfect the non-vital root canals and induce blood clot formation inside the root canal. One method places calcium hydroxide inside the root canal after disinfection and the blood clot is induced four weeks later.

The other method performs disinfection and induction of blood clot in one appointment. The investigators hypothesize that both methods will obtain the same success rate in eliminating infection, increase in root length and canal walls thickness.

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Key information

Conditions

Dental Pulp Necrosis Cardiovascular Diseases Dental Pulp Diseases Disorder of Tooth Development Embolism and Thrombosis Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Stomatognathic Diseases Thrombosis Tooth Diseases Vascular Diseases

Age range

6 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Graduate Endodontic Clinic

Ann Arbor, Michigan, 48109, United States

About this study

Collagen is placed on top of the blood clot, followed by white MTA. Glass ionomer is used to seal the access to the canal, which will be replaced by a permanent restoration 3 months later.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Healthy or having a mild systemic disease (ASA Physical Status 1 or 2), with no contraindications to the treatment.
  • Cooperative.
  • Clinical diagnosis of pulp necrosis based on cold test, electric pulp test as well as an identified cause of pulp necrosis such as caries, deep restorations, dental anomalies, history of trauma, associated with radiographic and/or clinic signs of periapical lesion.
  • Open apex with a diameter of at least 1mm. For teeth with more than one apical foramen, at least one foramen needs to be 1mm wide.
  • Tooth is restorable and periodontally stable.

Exclusion criteria

  • Pregnancy.
  • Evidence of pathological external or internal root resorption, root fracture or ankylosis.

Treatment and study plan

Endodontic Regeneration

Procedure

Blood clot formation is induced in the root canal after disinfection. Collagen material is placed over the clot. The canal access is sealed with white MTA and glass ionomer restoration. Permanent restoration is placed 3 months later on top of the MTA.

Primary outcomes

  1. Absence of infection and inflammation.

    Time frame: 12 and 24 months after the induction of blood clot

    clinic evaluation to determine the status of periodontal tissues

Secondary outcomes

  1. Changes in root length and canal wall width

    Time frame: Baseline and 12 months after the induction of blood clot

    Radiographic evaluation of these changes at 12 m as compared to the initial x-rays

  2. Changes in root length and canal wall width

    Time frame: Baseline and 24 months after the induction of blood clot

    Radiographic evaluation of these changes at 24 m as compared to the initial x-rays

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

A Randomized Controlled Clinical Trial of Regenerative Protocols to Treat Immature Necrotic Teeth

Important dates

Study start
2012
Primary completion
2023
Study completion
2023
First posted
Apr 9, 2013
Registry last updated
Jul 11, 2023

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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