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

Dental Pulp Necrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01827098
• Other study ID #: HUM-00066353
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: June 7, 2023

Study information

• Verified date: July 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 7, 2023
• Est. primary completion date: June 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Pulp Necrosis
• Disorder of Tooth Development
• Necrosis
• Tooth Diseases

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	Graduate Endodontic Clinic	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. — View 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]. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in root length and canal wall width	Radiographic evaluation of these changes at 12 m as compared to the initial x-rays	Baseline and 12 months after the induction of blood clot
Secondary	Changes in root length and canal wall width	Radiographic evaluation of these changes at 24 m as compared to the initial x-rays	Baseline and 24 months after the induction of blood clot

External Links

•   American Association of Endodontics - Considerations for Regenerative Procedures