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

NCT01827098 | Completed DMC

• 1 other identifier: HUM-00066353
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Pulp Necrosis; Disorder of Tooth Development

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Absence of infection and inflammation.

  clinic evaluation to determine the status of periodontal tissues

  12 and 24 months after the induction of blood clot

Secondary Outcomes (2)

• Changes in root length and canal wall width

  Baseline and 12 months after the induction of blood clot

• Changes in root length and canal wall width

  Baseline and 24 months after the induction of blood clot

Study Arms (2)

Delayed induction

EXPERIMENTAL

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.

Procedure: Endodontic Regeneration

Immediate Induction

EXPERIMENTAL

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

Procedure: Endodontic Regeneration

Interventions

Endodontic Regeneration 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.

Delayed induction; Immediate Induction

Eligibility Criteria

• Age: 6 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

Graduate Endodontic Clinic

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (7)

• 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.

  PMID: 15085044 BACKGROUND

• 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.

  PMID: 18041512 BACKGROUND

• 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.

  PMID: 18615992 BACKGROUND

• 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.

  PMID: 28844307 BACKGROUND

• 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.

  PMID: 21726222 BACKGROUND

• 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.

  PMID: 24935538 BACKGROUND

• 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.

  PMID: 20110511 BACKGROUND

Related Links

• American Association of Endodontics - Considerations for Regenerative Procedures

MeSH Terms

Conditions

Dental Pulp Necrosis; Thrombosis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Tatiana M Botero, DDS, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: January 7, 2013
• First Posted: April 9, 2013
• Study Start: October 1, 2012
• Primary Completion: June 7, 2023
• Study Completion: June 7, 2023
• Last Updated: July 11, 2023

Record last verified: 2023-07

Locations

US (1)