NCT01805388

Comparison of Tissue in Regenerative Endodontic Procedures and Apexification

Comparison of Tissue Formation in Regenerative Endodontic Procedures and Apexification

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Kenneth Hargreaves · Academic / Other
• Sex: All
• Age: 9 Years – 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of our study is to characterize the composition of the hard and soft tissues present after regenerative endodontic procedures in root canals of teeth previously diagnosed with the need for extraction for orthodontic treatment and incomplete root formation. Although the protocol addressed in this study is currently being used in clinical practice, there are no prospective clinical trials investigating its efficacy in stimulating continued root development and the nature of the newly formed tissues.

Detailed description

Twenty subjects with permanent bilateral premolar teeth with incomplete root development and scheduled for extraction due to orthodontic requirement will be treated with a regeneration protocol. Teeth (n=20/group) will be extracted at 3 months following the regenerative protocol or the pulpectomy control. The protocol relies on disinfection of the canal space by copious irrigation with common endodontic irrigants and placement of a triple antibiotic paste (regenerative group) or calcium hydroxide dressing (control group) to disinfect the root for a period of one month. In each patient, both treatment arms will be performed. Thus, each treatment sample will have a contralateral matching control (paired designs). At the end of one month, the intracanal medicaments (triple antibiotic paste) is irrigated out of the canal and a blood clot is stimulated in the canal with the aid of endodontic files that are introduced into the periapical tissues; this blood clot will serve as a scaffold for tissue proliferation within the canal. The regenerative treatment tooth is then restored to prevent bacteria from the oral cavity from re-contaminating the canal space. For the contralateral control tooth, the medication will remain in the tooth until the extraction date. The subjects in this study will have the treated teeth extracted at 3 months after initial treatment. The extracted teeth from each study participant will be placed in storage medium until Immunohistochemical analysis with antibodies to characterize the tissue/cells within the canal.

Conditions

• Dental Pulp Regeneration

Interventions

Type	Name	Description
DRUG	Experimental: Regeneration Treatment Group	Regenerative Root Canal Therapy using Triple Antibiotic Paste study drug
PROCEDURE	Control Non-Study Drug Group	Endodontic RTC with no study drug

Timeline

• Start date: 2013-02-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2013-03-06
• Last updated: 2016-02-05

Locations

1 site across 1 country: United States