Overview
Comparison of Tissue in Regenerative Endodontic Procedures and Apexification
Status:
Withdrawn
Withdrawn
Trial end date:
2015-10-01
2015-10-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Kenneth HargreavesTreatments:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Bacitracin
Bacitracin zinc, neomycin sulfate, polymyxin B, drug combination
Neomycin
Polymyxin B
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.