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

July 7, 2023 updated by: Tatiana Botero, University of Michigan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Graduate Endodontic Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Delayed induction
The root canal is disinfected and calcium hydroxide is placed in the canal. Blood clot is induced in the canal 4 weeks later. Endodontic Regeneration is performed.
Procedure: Endodontic Regeneration
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.
Experimental: Immediate Induction
Blood clot is induced after disinfection of the canal during the same visit. Endodontic regeneration is performed.
Procedure: Endodontic Regeneration
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 and 24 months after the induction of blood clot

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and 12 months after the induction of blood clot
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
Baseline and 24 months after the induction of blood clot

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Tatiana M Botero, DDS, MS, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2012

Primary Completion (Actual)

June 7, 2023

Study Completion (Actual)

June 7, 2023

Study Registration Dates

First Submitted

January 7, 2013

First Submitted That Met QC Criteria

April 4, 2013

First Posted (Estimated)

April 9, 2013

Study Record Updates

Last Update Posted (Actual)

July 11, 2023

Last Update Submitted That Met QC Criteria

July 7, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM-00066353

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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