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

Primary Purpose

Dental Pulp Necrosis, Disorder of Tooth Development

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Endodontic Regeneration

About this trial

This is an interventional treatment trial for Dental Pulp Necrosis focused on measuring Immature teeth, Calcium Hydroxide, Blood clot, Revascularization, Revitalization

Eligibility Criteria

6 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Graduate Endodontic Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Delayed induction

Immediate Induction

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Absence of infection and inflammation.

clinic evaluation to determine the status of periodontal tissues

Secondary Outcome Measures

Changes in root length and canal wall width

Radiographic evaluation of these changes at 12 m as compared to the initial x-rays

Changes in root length and canal wall width

Radiographic evaluation of these changes at 24 m as compared to the initial x-rays

Full Information

NCT ID

NCT01827098

First Posted

January 7, 2013

Last Updated

July 7, 2023

Sponsor

University of Michigan

1. Study Identification

Unique Protocol Identification Number

NCT01827098

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

October 2012 (Actual)

Primary Completion Date

June 7, 2023 (Actual)

Study Completion Date

June 7, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Pulp Necrosis, Disorder of Tooth Development

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Delayed induction

Arm Type

Experimental

Arm Description

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.

Arm Title

Immediate Induction

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Endodontic Regeneration

Intervention Description

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.

Primary Outcome Measure Information:

Title

Absence of infection and inflammation.

Description

clinic evaluation to determine the status of periodontal tissues

Time Frame

12 and 24 months after the induction of blood clot

Secondary Outcome Measure Information:

Title

Changes in root length and canal wall width

Description

Radiographic evaluation of these changes at 12 m as compared to the initial x-rays

Time Frame

Baseline and 12 months after the induction of blood clot

Title

Changes in root length and canal wall width

Description

Radiographic evaluation of these changes at 24 m as compared to the initial x-rays

Time Frame

Baseline and 24 months after the induction of blood clot

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tatiana M Botero, DDS, MS

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

Graduate Endodontic Clinic

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

15085044

Citation

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.

Results Reference

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PubMed Identifier

18041512

Citation

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.

Results Reference

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PubMed Identifier

18615992

Citation

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. Erratum In: Pediatr Dent. 2008 Jul-Aug;30(4):288. Giesler, Todd [corrected to Geisler, Todd].

Results Reference

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PubMed Identifier

28844307

Citation

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.

Results Reference

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PubMed Identifier

21726222

Citation

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.

Results Reference

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PubMed Identifier

24935538

Citation

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.

Results Reference

background

PubMed Identifier

20110511

Citation

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.

Results Reference

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Links:

URL

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

Description

American Association of Endodontics - Considerations for Regenerative Procedures

Learn more about this trial

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

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