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

University of Michigan

Status: Completed

Conditions: Disorder of Tooth Development; Dental Pulp Necrosis

Treatments: Procedure: Endodontic Regeneration

Study type: Interventional

Funder types: Other

Identifiers

NCT01827098

HUM-00066353

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 6 to 25 years old

Volunteers: No 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.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Delayed induction

Experimental group

Description:

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.

Treatment:

Procedure: Endodontic Regeneration

Immediate Induction

Experimental group

Description:

Blood clot is induced after disinfection of the canal during the same visit. Endodontic regeneration is performed.

Treatment:

Procedure: Endodontic Regeneration