Clinical trial NCT01827098: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dental Pulp Necrosis
Disorder of Tooth Development
Keywords: Immature teeth
Calcium Hydroxide
Blood clot
Revascularization
Revitalization
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2013-04-09
Enrollment: 45
Sex: ALL
Minimum age (years): 6
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Absence of infection and inflammation.
timeFrame: 12 and 24 months after the induction of blood clot
Secondary outcomes:
measure: Changes in root length and canal wall width
timeFrame: Baseline and 12 months after the induction of blood clot
measure: Changes in root length and canal wall width
timeFrame: Baseline and 24 months after the induction of blood clot
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Graduate Endodontic Clinic
state: Michigan
Study officials:
affiliation: University of Michigan
name: Tatiana M Botero, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.