Muhammad Zubair Ahmad
Ar Rass, Al-Qassim Region, 58883, Saudi Arabia
NCT Number: NCT06358833
Summary:
After a root canal procedure, it is common to experience postoperative pain. Cleaning the root canal thoroughly is crucial for pain relief, but removing all debris with standard methods is difficult. Irrigation, using either traditional endodontic needles or newer methods like endodontic activation, helps clean the canal. This study aims to compare pain levels after using conventional needles versus an Endo1 Ultrasonic Endo Activate Device for irrigation. Patients will undergo standard root canal preparation and then be randomly assigned to one of two groups for final irrigation: the Endo1 device (EA) and the conventional endodontic needles (EN). The study will provide insights into which method is more effective in reducing postoperative pain.
Looking for future studies?
Notify Me18 year–90 year
All sexes
Interventional
Not applicable
Ar Rass, Al-Qassim Region, 58883, Saudi Arabia
Background:
One of the primary objectives following root canal therapy is to alleviate pain. While postoperative pain is undesirable, it is often considered a common sensation following endodontic treatment.
Completely removing all organic and inorganic debris from the root canal system to ensure the elimination of irritants that can cause postoperative pain is a challenging task, even when using precise rotary, hand, or hybrid instruments. Therefore, irrigation plays a crucial role in the cleaning and shaping process.
Traditional root canal irrigation typically involves the use of an endodontic needle (EN) to disinfect the root canal. However, a newer approach called endodontic activation (EA) has been suggested to enhance root canal disinfection by activating irrigants within the canal.
Both of these methods of root canal irrigation are routine practice and part of the standard root canal treatment.
Rationale:
No study has directly compared the effects of final irrigation using conventional endodontic needles and an Endo1 Ultrasonic Endo Activate Device (Guilin Woodpecker, Guilin, China) on postoperative pain using a pragmatic approach. Therefore, the objective of this study is to assess and compare postoperative pain following the utilization of closed-ended endodontic needles and the Endo1 Ultrasonic Endo Activate Device during final root canal irrigation.
Study objectives:
The study aims to assess and compare the levels of postoperative pain following endodontic activation (EA) of irrigants using the Endo1 Ultrasonic Endo Activate Device (Guilin Woodpecker, Guilin, China) versus conventional endodontic needle (EN) irrigation in root canal therapy.
Methods In this prospective single-blind, parallel-armed, randomized clinical trial, standard root canal preparation will be done; patients will be randomly assigned into one of the two groups. In the final irrigation protocol, group EA will go through activation using Endo1 Ultrasonic Endo Activate Device while patients in group EN will receive irrigation by conventional endodontic needle technique.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
the irrigation of root canals will be done with 5.25 % sodium hypochlorite. The delivery of the irrigant will be done using a 30-gauge side-vented closed-end irrigation needle (NaviTip, Ultradent). The tip of the needle will be pre-measured and positioned within 1 millimeter of the working length. No activation of the irrigant will be performed.
the irrigation of root canals will be done with 5.25% sodium hypochlorite. The delivery of the irrigant will be done using a 30-gauge side-vented closed-end irrigation needle (NaviTip, Ultradent). The irrigant will be activated with ultrasonic energy using the Endo-1 Ultrasonic Endo Activate (Guilin Woodpecker, Guilin, China). The tip of the Endo-1 Ultrasonic Endo Activate device will be pre-measured and kept within 1 mm from the working length. The manufacturer's instructions regarding irrigant activation will be followed.
Time frame: 6 hours postoperatively
Postoperative pain will be measured using the Heft-Parker visual analog scale (VAS)
Time frame: 24 hours postoperatively
Postoperative pain will be measured using the Heft-Parker visual analog scale (VAS)
Time frame: 48 hours postoperatively
Postoperative pain will be measured using the Heft-Parker visual analog scale (VAS)
Time frame: 1 week postoperatively
Postoperative pain will be measured using the Heft-Parker visual analog scale (VAS)
Time frame: During and immediately after root canal treatment
If any adverse event will occur, it will be recorded
Time frame: Up-to 1 week postoperatively
In case of unbearable postoperative pain, the principal investigator will prescribe oral analgesic ibuprofen 400 mg (if Ibuprofen contraindicated, Paracetamol 500 mg), and the timepoint of medication intake will be recorded.
Qassim University
Other
Comparison of Postoperative Pain When Using an Endodontic Needle and Endo1 Ultrasonic Endo Activate Device During Root Canal Irrigation: A Randomized Controlled Pragmatic Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02417337
Irreversible Pulpitis, Neurologic Manifestations
Khartoum, Sudan
View Trial DetailsNCT06860100
Cardiovascular Diseases, Digestive System Diseases
Van, Tuşba, Turkey (Türkiye)
View Trial DetailsNCT07724678
Agnosia, Breast Cancer
Altındağ, Ankara, Turkey (Türkiye)
View Trial DetailsNCT07720999
Dental Caries, Neurologic Manifestations
Cairo, Cairo Governorate, Egypt
View Trial Details