Comparison of Clinical Outcomes Between GentleWave® and Biolase®
Endodontic Disease, Periapical Diseases, Periapical Periodontitis
About this trial
This is an interventional treatment trial for Endodontic Disease
Eligibility Criteria
Inclusion Criteria:
Male and female patients 14 years of age or older (maximum of 99 years of age)
o Participants 14 years of age or older are expected to have permanent teeth erupted in full permanent dentition with close apices
The subject tooth is indicated for root canal treatment
- One tooth indicated per participant
- Permanent tooth requiring root canal treatment which are deemed restorable
- Teeth exhibiting pulpal pathosis (irreversible pulpitis, pulpal necrosis, previously initiated root canal treatment) and apical periodontitis (with radiographic demonstration of periapical bone loss)
- Patient-signed informed consent/assent form
- Patients display good compliance o Patient is determined cooperative by provider during initial exam and radiographic acquisition
Exclusion Criteria:
- Patients allergic to local or topical anesthetics, heart disease (pacemakers, implantable defibrillators), lung disease, bleeding disorders, immune system deficiency
Subject tooth is not clinically restorable (prosthetically or periodontally)
- Mobility scores greater than or equal to 2
- Periodontal pocket depths greater than or equal to 6mm
- Cracks with radicular extension, vertical root fracture or horizontal - oblique fracture
- Subject tooth with open or incomplete apices (apical diameter greater than 1mm)
- Subject tooth has insufficient tooth structure to create GWS platform
- Subject tooth has external cervical root resorption
- Subject tooth has signs of dens invaginatus
- Subject tooth has signs of a palatogingival groove
- Subject tooth has root(s) which communicate with the maxillary antrum
- Patient has nonodontogenic facial pain
- Patient requires multiple teeth to be endodontically treated
Sites / Locations
- Univeristy of North Carolina Adams School of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Control group
GentleWave group
Waterlase group
Participants receive passive ultrasonic irrigation for endodontic irrigation treatment and will be followed for 12 months after treatment to assess radiographic healing of the periapex and clinical healing of the tooth.
Participants receive GentleWave System for endodontic irrigation treatment and will be followed for 12 months after treatment to assess radiographic healing of the periapex and clinical healing of the tooth.
Participants receive Waterlase iPlus for endodontic irrigation treatment and will be followed for 12 months after treatment to assess radiographic healing of the periapex and clinical healing of the tooth.