Comparison of Tissue in Regenerative Endodontic Procedures and Apexification

NCT01805388 | Withdrawn Phase 1 DMC

• 1 other identifier: HSC20130054H
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Pulp Regeneration

Keywords

Dental Pulp Regeneration

Outcome Measures

Primary Outcomes (1)

• Histological identification of the mineralized tissue at the apical third of the root and the adherent cellular layer.

  Although we predict histological identification of dentin/odontoblasts (due to the proximity of the apical papilla and associated SCAP stem cells) using our scanning laser confocal microscopy system, our methods are sufficiently sensitive to permit identification of bone/osteoblasts and cementum/cementoblasts as alternative hypotheses.

  Following tooth extraction at the 3 month followup visit. Correlation of all data collected from the extracted teeth will occur at the completion of the study at year 5.

Secondary Outcomes (1)

• Whether stem cells enter the canal space when bleeding is stimulated through manipulation of the apical papilla.

  Canal bleeding is evoked during the second treatment visit thirty days following the first treatment. Blood collected by paper points will be saved till the end of the study (year 5) for analysis.

Study Arms (2)

Regeneration Treatment Group

EXPERIMENTAL

RTC with Triple Antibiotic Study Drug

Drug: Experimental: Regeneration Treatment Group; Procedure: Control Non-Study Drug Group

Control Non-study Drug Group

NO INTERVENTION

RTC on contralateral tooth with no study drug

Interventions

Experimental: Regeneration Treatment Group DRUG

Regenerative Root Canal Therapy using Triple Antibiotic Paste study drug

Also known as: Regenerative RTC using Triple Antibiotic Paste study drug

Regeneration Treatment Group

Control Non-Study Drug Group PROCEDURE

Endodontic RTC with no study drug

Also known as: Root Canal Therapy

Regeneration Treatment Group

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children ages 9-18 with bilateral premolars with incomplete root development scheduled for extraction for orthodontic reasons.
• Children who seem to be cooperative with dental treatment and able to indicate willingness to obtain treatment and participate in the study and who are capable of verbally expressing dissent.
• Parents who express understanding of study treatments and consent to treatment for their child of the regenerative procedure prior to the tooth extraction for orthodontic reasons .
• Healthy patients (ASA Class I or II physical status) with no systemic health problems that may interfere with healing and cell growth.
• Permanent premolar teeth with immature root development and healthy pulps scheduled for extraction due to orthodontic requirements.
• Clinically confirmed teeth with good periodontal health assessed by periodontal probing depths of less than 4mm.

You may not qualify if:

• Parents and patients unable to give consent or express dissent.
• Patients who are unwilling to undergo the research and orthodontic dental treatment.
• Patients affected by tempromandibular joint disorders.
• Patients affected by known orofacial pain disorders.
• Patients with ASA Class III or IV physical status (Immuno-compromised patients including patients who self-report that they are an HIV carrier, undergoing steroid therapy or chemotherapy, or those who self-report with genetic or systemic diseases that could result in reduced immune response).
• Teeth with vertical cracks that extend below the cemento-enamel junction.
• Teeth that cannot be isolated using a rubber dam.
• Teeth with non-odontogenic pathology.
• Teeth whose apices are fully developed, as determined radiographically and correlated with dental age of patient.

Sponsors & Collaborators

• Kenneth Hargreaves: lead

Study Sites (1)

University of Texas Health Science Center

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Thibodeau B. Case report: pulp revascularization of a necrotic, infected, immature, permanent tooth. Pediatr Dent. 2009 Mar-Apr;31(2):145-8.

  PMID: 19455934 BACKGROUND

MeSH Terms

Interventions

Root Canal Therapy

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Study Officials

• Anibal R Diogenes, DDS, PhD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

• Dubravko Pavlin, DMD, PhD

  University of Texas Health Science Center San Antonio

  PRINCIPAL INVESTIGATOR

• Kenneth M Hargreaves, DDS, PhD

  University of Texas Health Science Center San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: February 28, 2013
• First Posted: March 6, 2013
• Study Start: February 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 5, 2016

Record last verified: 2016-02

Locations

US (1)