Completed
A Randomized Controlled Clinical Trial of Regenerative Protocols to Treat Immature Necrotic Teeth
What is being tested
Endodontic Regeneration
+ Endodontic Regeneration
Procedure
Who is being recruted
Cardiovascular Diseases+8
+ Dental Pulp Diseases
+ Stomatognathic Diseases
From 6 to 25 Years
+7 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: October 2012
Summary
Principal SponsorUniversity of Michigan
Last updated: July 11, 2023
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2012
Actual date on which the first participant was enrolled.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.
Principal SponsorUniversity of Michigan
Last updated: July 11, 2023
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
45 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 6 to 25 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Cardiovascular DiseasesDental Pulp DiseasesStomatognathic DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsTooth DiseasesVascular DiseasesEmbolism and ThrombosisDental Pulp NecrosisThrombosis
Criteria
5 inclusion criteria required to participate
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
Cooperative
Healthy or having a mild systemic disease (ASA Physical Status 1 or 2), with no contraindications to the treatment
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
Show More Criteria
2 exclusion criteria prevent from participating
Evidence of pathological external or internal root resorption, root fracture or ankylosis
Pregnancy
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalThe 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.
Group II
ExperimentalBlood clot is induced after disinfection of the canal during the same visit.
Endodontic regeneration is performed.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center