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

Sponsor

University of Michigan (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01827098

Collaborator

(none)

Enrollment

Location

Arms

123

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Pulp Necrosis Disorder of Tooth Development	Procedure: Endodontic Regeneration	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2012

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Absence of infection and inflammation. [12 and 24 months after the induction of blood clot]

Secondary Outcome Measures

Changes in root length and canal wall width [Baseline and 12 months after the induction of blood clot]
Changes in root length and canal wall width [Baseline and 24 months after the induction of blood clot]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.