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

Not Applicable

Completed

• Conditions: Disorder of Tooth Development; Dental Pulp Necrosis
• Interventions: Procedure: Endodontic Regeneration

• Registration Number: NCT01827098
• Lead Sponsor: University of Michigan

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-01-07
• Study First Submitted QC: 2013-04-04
• Study First Posted: 2013-04-09
• Primary Completion: 2023-06-07
• Study Completion: 2023-06-07
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-07
• Last Update Posted: 2023-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delayed induction	Endodontic Regeneration	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.
Immediate Induction	Endodontic Regeneration	Blood clot is induced after disinfection of the canal during the same visit. Endodontic regeneration is performed.

Primary Outcome Measures

Name	Time	Method
Absence of infection and inflammation.	12 and 24 months after the induction of blood clot	clinic evaluation to determine the status of periodontal tissues

Secondary Outcome Measures

Name	Time	Method
Changes in root length and canal wall width	Baseline and 24 months after the induction of blood clot	Radiographic evaluation of these changes at 24 m as compared to the initial x-rays

Trial Locations

Locations (1)

Graduate Endodontic Clinic; 🇺🇸 Ann Arbor, Michigan, United States