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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Dental Pulp Necrosis, Disorder of Tooth Development

Intervention / Treatment
-----------------
* Procedure: Endodontic Regeneration


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 25 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Delayed induction<br>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<br>* 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.<br>|
| Experimental: Immediate Induction<br>Blood clot is induced after disinfection of the canal during the same visit. Endodontic regeneration is performed. | Procedure: Endodontic Regeneration<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of infection and inflammation. | 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 | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immature teeth, Calcium Hydroxide, Blood clot, Revascularization, Revitalization