A Randomized Controlled Clinical Trial of Regenerative Protocols to Treat Immature Necrotic Teeth
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Absence of infection and inflammation.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 25 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Endodontic Regeneration (Procedure)
Immediate Induction
Blood clot is induced after disinfection of the canal during the same visit. Endodontic regeneration is performed.
Intervention: Endodontic Regeneration (Procedure)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Changes in root length and canal wall width(Baseline and 24 months after the induction of blood clot)
- Changes in root length and canal wall width(Baseline and 12 months after the induction of blood clot)
Investigators
Tatiana Botero
Clinical Associate Professor
University of Michigan