Comparison of Tissue in Regenerative Endodontic Procedures and Apexification

Withdrawn before enrolling · Phase 1

Conditions studied: Dental Pulp Regeneration

In brief

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.

Key facts

Study ID

NCT01805388

Run by

Kenneth Hargreaves

People needed

0

Starts

2013-02-01

Expected to finish

2015-10-01

Last updated by the study team

2016-02-05

Who can join

Age: 9 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patient Inclusion Criteria:
• 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.
• Tooth inclusion criteria:
• 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…

• Patient Exclusion Criteria:
• 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).
• Tooth Exclusion Criteria:
• 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.

Where it is running

• University of Texas Health Science Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.