Healthy PatientsNCT06257199
Real-time Measurement of Intra-canal Temperature in Vivo
An observational study of Healthy Patients, run by King Abdullah University Hospital at 1 site in Jordan.
Trial summary
Included patients will be attending the dental clinics for a root canal treatment. After explaining the procedure and obtaining their consent, the intracanal temperature of the treated tooth will be measured after irrigation with normal saline at 2 different temperatures: 22- and 45-degree Celsius. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Patients
- How many people
- 20 participants
- Where
- 1 siteJordan
- Study dates
- 29 May 2023to 28 Jan 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: health patient attend the Dental teaching center at Jordan university of science and technology were recruited for the current study, patient was aware of the process and signed informed consent in which accept to measure the temperature of the canals, patient was informed with all safty measure.
Who may be able to join
- Health patients ASA I-II non pregnant women
Who cannot join
- ASA III and above pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-Time Morphometric Changes of Temperature-Sensitive NiTi Endodontic Instruments in Relation to Intracanal Temperature
Included patients will be attending the dental clinics for a root canal treatment. After explaining the procedure and obtaining their consent, the intracanal temperature of the treated tooth will be measured after irrigation with normal saline at 2 different temperatures: 22- and 45-degree Celsius. The intraoral temperature will be recorded using a thermocouple probe inserted inside the canal at the mid-root level. Intraoral temperature will be recorded at the same time using another probe attached to the lingual mucosa. A video will be recorded for the temperature changes over 180 seconds duration starting from the time of placing the irrigation solution into the canal.
Read the 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.
- Conditions
- Healthy Patients
- Keywords
- Irrigation, Intracanal, temperature
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-time intra canal temperature measurements
assessing the temperature changes inside the root canal system that might influence the rotary files performance
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start29 May 2023
- Primary completion29 Dec 2023
- Study completion28 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257199
- Sponsor's protocol ID
- 20230248
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-Time Morphometric Changes of Temperature-Sensitive NiTi Endodontic Instruments in Relation to Intracanal Temperature
- ClinicalTrials.gov ID
- NCT06257199
- Acronym / sponsor ID
- 20230248
- Conditions
- Healthy Patients
- Keywords
- Irrigation, Intracanal, temperature
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Study start
- 29 May 2023 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 28 Jan 2024 (actual)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Included patients will be attending the dental clinics for a root canal treatment. After explaining the procedure and obtaining their consent, the intracanal temperature of the treated tooth will be measured after irrigation with normal saline at 2 different temperatures: 22- and 45-degree Celsius. The intraoral temperature will be recorded using a thermocouple probe inserted inside the canal at the mid-root level. Intraoral temperature will be recorded at the same time using another probe attached to the lingual mucosa. A video will be recorded for the temperature changes over 180 seconds duration starting from the time of placing the irrigation solution into the canal.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- health patient attend the Dental teaching center at Jordan university of science and technology were recruited for the current study, patient was aware of the process and signed informed consent in which accept to measure the temperature of the canals, patient was informed with all safty measure.
Key inclusion criteria (1 listed)
- Health patients ASA I-II non pregnant women
Key exclusion criteria (1 listed)
- ASA III and above pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
Related trials for Healthy Patients
RecruitingPhase 2
Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models
Idiopathic CD4-Positive, T-Lymphocytopenia
Not yet recruitingObservational study
Screening Protocol
Pain
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
Active, not recruiting
Role of Interleukin-13 Pathways on Pain and Itch Sensitivity ( IL-13 )
Itching
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Patients, run by King Abdullah University Hospital at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real-time intra canal temperature measurements (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.