- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06257199
Real-time Measurement of Intra-canal Temperature in Vivo
Real-Time Morphometric Changes of Temperature-Sensitive NiTi Endodontic Instruments in Relation to Intracanal Temperature
Study Overview
Status
Conditions
Detailed Description
- Measurement of intracanal temperature in vivo Healthy patients attending the dental clinics for non-surgical root canal treatment of permanent mandibular first molars will be included in the study after obtaining ethical approval (IRB ethical approval ref. 10/158/2023). Their body temperature will be measured using a non-contact thermometer pointed at the forehead. Any patient with a body temperature higher than 37°C will not be included. The participants will sign a consent form after the procedure is fully explained. Upon rubber dam isolation, access cavity preparation will be performed, and canals will be chemo-mechanically prepared using a ProTaper Gold NiTi rotary system (Dentsply Sirona, Switzerland). Distal canals will be prepared up to the F3.
A four-channel portable thermometer will be used with two K-type thermocouple probes to simultaneously measure both intracanal and intraoral temperatures. The intraoral temperature will be measured by securing the probe in direct contact with the lingual alveolar mucosa under the rubber dam. The intracanal temperature will be measured by another probe inserted inside the distal canal at the mid-root level. The insertion depth will be verified using a preoperative radiograph and a rubber stop. If the probe insertion to that depth is not possible, the tooth will be excluded. Based on a previous study, 20 teeth will be included in the experiment. In each canal, two measurements will be obtained; the first one will be irrigated using a normal saline set at room temperature (RT), and the other measurement will be taken after irrigation using heated temperature (HT) normal saline . The RT irrigation solution will be used while maintaining the ambient temperature of the air-conditioned clinic fixed at 22°C. The HT irrigation solution will be heated using a chairside dental composite heater set at 45°C. The preset temperatures of each irrigation group will be confirmed with 3 repeated measurements.
After securing the thermocouple probe inside the canal, the RT irrigation solution will be applied using a gauge-27 side vented needle. A video camera will be used for recording the change of both intraoral and intracanal temperatures appearing on the digital display of the thermometer for 180 seconds. After 5 min, the canal will be dried, and the HT irrigation solution will be applied repeating the same steps.
The thermocouple probes will be chemically sterilized before each use. From the video recordings, still frames will be extracted at 5-second intervals using the VLC media player plotting the body and intracanal temperature at each time point.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Irbid, Jordan, 22110
- Dr.Taher Al Omari
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Health patients ASA I-II non pregnant women
Exclusion Criteria:
- ASA III and above pregnant women
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Real-time intra canal temperature measurements
Time Frame: 6 months
|
assessing the temperature changes inside the root canal system that might influence the rotary files performance
|
6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 20230248
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Healthy Patients
-
National and Kapodistrian University of AthensCompletedHealthy PatientsGreece
-
Renata Martins da Silva PradoUniversity of Sao PauloCompleted
-
Ghurki Trust and Teaching HospitalCompleted
-
National Institutes of Health Clinical Center (CC)Recruiting
-
Yantai LNC Biotechnology Singapore PTE. LTD.Not yet recruiting
-
Yantai LNC Biotechnology Singapore PTE. LTD.Not yet recruiting
-
Tel-Aviv Sourasky Medical CenterUnknownIOP Changes Due to Anesthesia (Healthy Patients)Israel
-
University Hospital, GrenobleCompletedHealthy Volunteer | Patients Under Vitamin K Antagonist (VKA)France
-
University Health Network, TorontoCompletedComparing Head And Neck Endoscopy in Healthy PatientsCanada
-
Universitaire Ziekenhuizen KU LeuvenCompleted