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

NCT ID: NCT01827098

Last Updated: 2023-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2023-06-07

Brief Summary

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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

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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.

Conditions

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Dental Pulp Necrosis Disorder of Tooth Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Endodontic Regeneration

Intervention Type PROCEDURE

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.

Immediate Induction

Blood clot is induced after disinfection of the canal during the same visit. Endodontic regeneration is performed.

Group Type EXPERIMENTAL

Endodontic Regeneration

Intervention Type PROCEDURE

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.

Interventions

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Endodontic 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Tatiana Botero

Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tatiana M Botero, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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Graduate Endodontic Clinic

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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Banchs F, Trope M. Revascularization of immature permanent teeth with apical periodontitis: new treatment protocol? J Endod. 2004 Apr;30(4):196-200. doi: 10.1097/00004770-200404000-00003.

Reference Type BACKGROUND
PMID: 15085044 (View on PubMed)

Thibodeau B, Trope M. Pulp revascularization of a necrotic infected immature permanent tooth: case report and review of the literature. Pediatr Dent. 2007 Jan-Feb;29(1):47-50.

Reference Type BACKGROUND
PMID: 18041512 (View on PubMed)

Hargreaves KM, Geisler T, Henry M, Wang Y. Regeneration potential of the young permanent tooth: what does the future hold? Pediatr Dent. 2008 May-Jun;30(3):253-60.

Reference Type BACKGROUND
PMID: 18615992 (View on PubMed)

Botero TM, Tang X, Gardner R, Hu JCC, Boynton JR, Holland GR. Clinical Evidence for Regenerative Endodontic Procedures: Immediate versus Delayed Induction? J Endod. 2017 Sep;43(9S):S75-S81. doi: 10.1016/j.joen.2017.07.009.

Reference Type BACKGROUND
PMID: 28844307 (View on PubMed)

Rosa V, Botero TM, Nor JE. Regenerative endodontics in light of the stem cell paradigm. Int Dent J. 2011 Aug;61 Suppl 1(Suppl 1):23-8. doi: 10.1111/j.1875-595X.2011.00026.x.

Reference Type BACKGROUND
PMID: 21726222 (View on PubMed)

Schneider R, Holland GR, Chiego D Jr, Hu JC, Nor JE, Botero TM. White mineral trioxide aggregate induces migration and proliferation of stem cells from the apical papilla. J Endod. 2014 Jul;40(7):931-6. doi: 10.1016/j.joen.2013.11.021. Epub 2014 Jan 16.

Reference Type BACKGROUND
PMID: 24935538 (View on PubMed)

Botero TM, Son JS, Vodopyanov D, Hasegawa M, Shelburne CE, Nor JE. MAPK signaling is required for LPS-induced VEGF in pulp stem cells. J Dent Res. 2010 Mar;89(3):264-9. doi: 10.1177/0022034509357556. Epub 2010 Jan 28.

Reference Type BACKGROUND
PMID: 20110511 (View on PubMed)

Related Links

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http://www.aae.org/regeneration/

American Association of Endodontics - Considerations for Regenerative Procedures

Other Identifiers

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HUM-00066353

Identifier Type: -

Identifier Source: org_study_id

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