Post-Operative Pain Clinical Trial
Official title:
Post-operative Pain Following Treatment Using the Gentlewave System
This is a clinical study that will investigate the occurrence of post-operative discomfort following the use of the Gentlewave System for root canal disinfection and irrigation. Assessment of discomfort level will be via a visualized analog pain scale.
Once a tooth reaches a level of inflammation where healing can no longer occur or when the pulp space begins to go through necrosis, root canal treatment is indicated. The goal of root canal therapy is to clean, shape, disinfect, and obturate all canal systems within the tooth. Schilder's mechanical and biological objectives for cleaning and shaping includes: preparing a continuous tapering root canal funnel from access to apex, cross-sectional diameters should be wider at every point as you move coronally, the preparation should occupy as may planes as presented by the original canal and should follow the shape of the original canal, the apical foramen should remain in it is original spatial relationship to bone and to root surface, the apical opening should be kept as small as practical in all cases, complete cleaning and shaping in one appointment, procedures should be confined to the roots themselves, necrotic debris should not be forced beyond the foramina, all tissues should be removed from root canal space, and sufficient space for intracanal medicaments and irrigation should be created. Traditionally, the standard protocol for cleaning and shaping is completed using multiple hand or rotary files. Siqueira discovered that the factors that are commonly responsible for post-operative or interappointment pain include mechanical preparation and obturation beyond the apex, bacterial insults not present in the primary infection, and chemical extrusion of irrigant materials beyond the apex. Post-operative pain can occur hours to days following root canal procedures. Irrigation dissolves organic material and kills microbes. It also helps prevent the binding of instruments, improves the cutting effectiveness of files, dissolves tissue, and cools the instrument and tooth. The most common endodontic irrigant is sodium hypochlorite. Sodium hypochlorite is an alkaline fluid with a pH of approximately 11-12. It hydrolyzes proteins and causes hemolysis of red blood cells which leads to the dissolution of vital, as well as necrotic tissue. Upon contact of organic debris, hypochlorus acid forms which disrupts bacterial metabolism by oxidizing the sulfhydryl group of bacterial enzymes. The purpose of this study is to determine whether a new treatment modality for cleaning and disinfecting the root canal system will significantly affect the occurrence and severity of post-operative pain. Patients will be randomly divided into two groups, control and research. The control group will have the standard root canal procedure. The research group will have a root canal treatment that includes irrigation and disinfection with the Gentlewave system, thus eliminating the need for multiple rotatory files and multiple irrigation steps. Patients will be asked to complete a visual analog pain scale rating for pretreatment pain, as well as the same visual assessment scale for pain 6, 24, 72, & 168 hours following treatment. The results of the study should show that following Gentlewave treatment patients will experience less severe post-operative pain, if any at all. The findings should support a treatment modality that retains tooth structure while completely removing necrotic debris and bacteria, as well as causing minimal to no post-operative pain. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02489526 -
Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injections for Post-Operative Pain Following Colorectal Surgery
|
Phase 2 | |
Completed |
NCT05635916 -
Trial of Liposomal Bupivacaine for TKA
|
Phase 4 | |
Terminated |
NCT05146453 -
Sternotomies and PectoIntercostal Fascia Blocks in Fast-Track Cardiac Anesthesiology
|
Phase 4 | |
Recruiting |
NCT06028126 -
Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial
|
N/A | |
Not yet recruiting |
NCT03591172 -
Using Three Different Final Irrigants and Showing Their Effects on the Success of Revascularization
|
N/A | |
Completed |
NCT01686802 -
Post-operative Oral Morphine Versus Ibuprofen
|
Phase 2 | |
Completed |
NCT01667445 -
Evaluation of the Use of Spinal Epimorph in Total Knee Arthroplasty
|
Phase 4 | |
Completed |
NCT01444924 -
Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery
|
Phase 2 | |
Completed |
NCT00968955 -
Effect of Local Infiltration Analgesia in Total Hip Arthroplasty
|
Phase 4 | |
Completed |
NCT00830089 -
Trial of a Transversus Abdominis Plane (TAP) Block in Laparoscopic Colorectal Surgery
|
N/A | |
Completed |
NCT00847093 -
LMX-4 for Postoperative Pain Management in Infants and Children Undergoing Penoplasty Surgery
|
Phase 4 | |
Terminated |
NCT00875862 -
Shoulder Adhesive Capsulitis and Ambulatory Continuous Interscalene Nerve Blocks
|
Phase 4 | |
Completed |
NCT00390312 -
Efficacy and Safety of Intranasal Morphine for Pain After Third Molar Extraction
|
Phase 2 | |
Recruiting |
NCT05278494 -
Dextromethorphan for Treatment of Postoperative Pain
|
N/A | |
Recruiting |
NCT05973045 -
Investigation of the Effect of Distention Medium Temperature on Image Quality, Hyponatremia Risk, and Post-operative Pain in Operative Hysteroscopy
|
N/A | |
Not yet recruiting |
NCT04999670 -
Fascial Closure and Post-caesarean Pain
|
N/A | |
Enrolling by invitation |
NCT04346407 -
Dronabinol for Post-operative Pain After Lumbar Fusion
|
Phase 4 | |
Terminated |
NCT03201809 -
Comparison of Preoperative Ultrasound Guided Pectoralis Nerve Block Placement Versus Intra-operative Placement: A Prospective Randomized Trial
|
N/A | |
Completed |
NCT03254056 -
Fascial Closure Techniques Post-Operative Pain Laparoscopy
|
N/A | |
Not yet recruiting |
NCT02555423 -
The Effects of Serratus Plane Block Performed Under Direct Vision on Post-operative Pain in Breast Surgery
|
N/A |