Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01827098
Enrollment
45
Registered
2013-04-09
Start date
2012-10-31
Completion date
2023-06-07
Last updated
2023-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Pulp Necrosis, Disorder of Tooth Development

Keywords

Immature teeth, Calcium Hydroxide, Blood clot, Revascularization, Revitalization

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.

Interventions

PROCEDUREEndodontic 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.

Sponsors

University of Michigan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 25 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Absence of infection and inflammation.12 and 24 months after the induction of blood clotclinic evaluation to determine the status of periodontal tissues

Secondary

MeasureTime frameDescription
Changes in root length and canal wall widthBaseline and 12 months after the induction of blood clotRadiographic evaluation of these changes at 12 m as compared to the initial x-rays

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026