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

University of Michigan45 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dental Pulp Necrosis Disorder of Tooth Development

Interventions

Eligibility

Sex: ALLMin age: 6 YearsMax age: 25 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Absence of infection and inflammation.

clinic evaluation to determine the status of periodontal tissues

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

Secondary Outcomes

Changes in root length and canal wall width

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

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