Comparison of Tissue Formation in Regenerative Endodontic Procedures and Apexification
Experimental: Regeneration Treatment Group
+ Control Non-Study Drug Group
Prevention Study
Summary
Study start date: February 1, 2013
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 9 to 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
No InterventionStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University of Texas Health Science Center
San Antonio, United StatesOpen University of Texas Health Science Center in Google Maps