- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01805388
Comparison of Tissue in Regenerative Endodontic Procedures and Apexification
February 4, 2016 updated by: Kenneth Hargreaves
Comparison of Tissue Formation in Regenerative Endodontic Procedures and Apexification
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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San Antonio, Texas, United States, 78229
- University of Texas Health Science Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Regeneration Treatment Group
RTC with Triple Antibiotic Study Drug
|
Regenerative Root Canal Therapy using Triple Antibiotic Paste study drug
Other Names:
Endodontic RTC with no study drug
Other Names:
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No Intervention: Control Non-study Drug Group
RTC on contralateral tooth with no study drug
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Histological identification of the mineralized tissue at the apical third of the root and the adherent cellular layer.
Time Frame: 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.
|
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.
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Whether stem cells enter the canal space when bleeding is stimulated through manipulation of the apical papilla.
Time Frame: 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.
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This secondary outcome measure will be conducted by measuring markers of stem cells prior to and after the formation of the blood clot.
We predict that evoking bleeding into the root canal system will increase the delivery of mesenchymal stem cells.
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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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: 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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
February 28, 2013
First Submitted That Met QC Criteria
March 4, 2013
First Posted (Estimate)
March 6, 2013
Study Record Updates
Last Update Posted (Estimate)
February 5, 2016
Last Update Submitted That Met QC Criteria
February 4, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC20130054H
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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