Endodontically Treated TeethPhase 4NCT06134713
Effect of Intra-Canal Cryotherapy on Postoperative Pain After Endodontic Procedures
A Phase 4 study testing cryotherapy with sterile saline at 2.5ºC in people with Endodontically Treated Teeth and Post Operative Pain, run by Ajman University at 1 site in United Arab Emirates.
Trial summary
The goal of this randomised clinical trial is to evaluate the effect of cryotherapy on postoperative pain after primary and secondary root canal treatment. The main question[s] it aims to answer are: Dose cryotherapy help reduce postoperative pain after primary root canal treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endodontically Treated Teeth, Post Operative Pain
- What is being tested?
- cryotherapy with sterile saline at 2.5ºC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 15 May 2023to 30 May 2024
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients older than 18 years.
- Patients who demonstrate understanding of the study and willingness to participate as evidenced by signing the voluntary informed consent and who received a signed and dated copy of the informed consent form.
- Patients who understand and are willing to comply with all study procedures and restrictions.
- Absence of clinically significant and relevant abnormalities in the clinical history or oral examination.
- Endodontic treatment considered the treatment of choice for both multi and single rooted teeth.
- Endodontic retreatment considered the treatment of choice only in posterior molar teeth (multirooted).
- Only one treatment per patient.
Who cannot join
- Patients who are allergic to any of the materials used in the treatment.
- Patients with heart pacemaker.
- Patients with any general pathology that requires antibiotic prophylaxis.
- Root resorption, root fractures, impossibility of restoration.
- Pregnant patients.
- Patients who took painkillers in the last 6 hours.
Show all 9Show fewer
- Case where apical patency couldn't be achieved
- Cases where final obturation quality is compromised.
- Any intra operative factor that complication that can compromise the treatment outcome like root perforation or fractured instrument or inability to localize/prepare any canal.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intra-Canal Cryotherapy on Post Operative Pain After Primary and Secondary Root Canal Treatment: A Randomized Controlled Trial
The goal of this randomised clinical trial is to evaluate the effect of cryotherapy on postoperative pain after primary and secondary root canal treatment. The main question[s] it aims to answer are:
- Dose cryotherapy help reduce postoperative pain after primary root canal treatment.
- Dose cryotherapy help reduce postoperative pain after secondary root canal treatment.
Participants will be randomly divided to receive either cryotherapy or irrigation with normal saline and the effect between the two groups in terms of postoperative pain will be compared after primary and secondary root canal treatment.
Read the detailed description
Procedure
Previous pain assessment:
Both pre- and postoperative pain will be assessed using Huskinsson's visual analog scale (VAS). According to the quantitative data obtained from the VAS scale, these values are categorized as follows: no pain (0), slight pain (0.1-3.9), moderate pain (4-6.9) or pain severe (7-10).
Informed consent After the procedure is carefully explained to the patient and the patient has accepted the treatment plan and signed the Consent, they will be included in the study. Students will give a complete explanation of the study, the forms of pain and how to properly fill out the pain form. If the patient wishes to participate, they will sign the document in order to continue with the treatment and be included in the study.
Root canal treatment and retreatment Vitality test which includes cold test using Endo Ice (Coltene, Switzerland) and Electrical pulp test (EPT) (Shadental, India) for cases of primary root canal treatment. Vertical and lateral percussion tests, periodontal probing, and periapical and bitewing radiographs will be performed in order to perform the pulpal and periapical diagnosis.
The general treatment protocol will be the same for all groups. In case of primary root canal treatment, after the clinical examination, the cold test (Endo-Frost, Coltene-Whaledent, Langenau, Germany) will be used to determine the vitality of the pulp, which will be verified by the presence or absence of bleeding from the root canals during the preparation of the pulp endodontic access.
Local infiltration with 2% lidocaine with epinephrine 1: 80,000 (Ultracain, Normon) will be performed, and absolute isolation with a rubber dam and the department's endodontic protocol will be followed. Access cavity with sterile round diamond drills and Endo-Z drills (Dentsply Maillefer, Ballaigues, Switzerland). The working length (WL) is established with a #10 K-file and apex locator and confirmed with a periapical radiograph. In case of secondary root canal treatment, gutta percha removal and disobturation will be done using different types of rotary and manual files and canals will be negotiated till patency is achieved in all canals, if patency is not achieved the case will be excluded from the study. After which for both primary and secondary root canal treatment instrumentation of the canals will be performed in which they will be irrigated with 1.3% NaOCl solution using a plastic syringe and side-exit needle (Max-i-probe, Kerr-Hawe, Bioggio, Switzerland). Apical patency will be maintained throughout the procedure. Once the procedure is complete, 1 ml of 17% EDTA will be used and a final irrigation with 1.3% NaOCl will be performed with ultrasonic activation using the Irrisafe tip (Acteon, UK).
In the control group, a final irrigation will be performed with 5 ml of 0.9% physiological saline (Sodium Chloride IV infusion 0.9% (Gulf Inject LLC)) at room temperature and in the experimental group with the saline at 2.5ºC for 4 minutes with an endo needle inserted at working length. The saline solution for the control group will be kept at room temperature. The saline solution of the experimental groups will be kept in a refrigerator set at 2.5 C until clinical use.
- Group 1: Conventional root canal treatment with final irrigation with saline at room temperature (n=30).
- Group 2: Conventional root canal retreatment with final irrigation with saline at room temperature (n=30).
- Group 3: Conventional root canal treatment with final irrigation with saline at 2.5ºC for 4 minutes (n=30).
- Group 2: Conventional root canal retreatment with final irrigation with saline at 2.5ºC for 4 minutes (n=30).
The canals will be dried with paper points. The canals of both groups will be filled using a warm gutta-percha filling technique. AH-Plus cement (Dentsply, DeTrey GmbH, Konstanz, Germany) will be used as root canal sealer. Each coronal access will be sealed with a flowable resin (Tetric, IvoclarVivadent AG, SchaanFurstentum, Liechtenstein) and the access cavity will be filled with Glass Ionomer Cement (GIC, ESPE dental, Seefeld, Germany).
Post-operative pain assessment A sheet will be given to the patient with different lines of VAS so that the patient reports the intensity of pain or its absence in the same way that he has been previously taught with preoperative pain at 8, 24 and 48h, 7 days. An ibuprofen 600 mg every 8-12 hours will be recommended for pain control when necessary. The type of analgesic, its quantity and dose will also be recorded in the event that the patients take any type of medication. Patients will be asked to return the VAS collection sheet at the next restoration or general treatment plan continuation visit at the University Clinic. Both the preoperative and postoperative pain results recorded on the Huskinsson VAS scale will be measured by an operator independent of the study, who will be previously calibrated, teaching the evaluator to measure 10 times with a ruler the distance between the initial point of the line to the point marked by the patient on it.
- Conditions
- Endodontically Treated Teeth, Post Operative Pain
- Being tested
- cryotherapy with sterile saline at 2.5ºC, control with sterile saline at room temperature
- Keywords
- Root Canal Treatment, Post Operative Pain, Cryotherapy, Nonsurgical Root Canal Retreatment
- Medical subject headings
- Tooth, Nonvital, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryotherapy with sterile saline at 2.5ºCDrug
In the cryotherapy (experimental group), final irrigation will be performed with 5 ml of 0.9% physiological sterile saline kept refrigerated at 2.5ºC and will be delivered for 1 or 4 minutes with a side vented needle inserted at working length for each canal.
control with sterile saline at room temperatureDrug
In the control group, final irrigation will be performed with 5 ml of 0.9% physiological sterile saline kept at room temperature and will be delivered for 1 or 4 minutes with a side vented needle inserted at working length for each canal.
| Study group | Role | What they receive |
|---|---|---|
| Root canal treatment cryotherapy group | Experimental | Conventional root canal treatment with final irrigation using sterile saline at 2.5ºC Receives: Drug: cryotherapy with sterile saline at 2.5ºC |
| Root canal RE-treatment cryotherapy group | Experimental | Conventional root canal RE-treatment with final irrigation using sterile saline at 2.5ºC Receives: Drug: cryotherapy with sterile saline at 2.5ºC |
| Root canal treatment control group | Active comparator | Conventional root canal treatment with final irrigation using sterile saline at room temperature Receives: Drug: control with sterile saline at room temperature |
| Root canal RE-treatment control group | Active comparator | Conventional root canal RE-treatment with final irrigation using sterile saline at room temperature Receives: Drug: control with sterile saline at room temperature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain assessment using the visual analog scale (VAS)
Both pre- and postoperative pain will be assessed using the visual analog scale (VAS). According to the quantitative data obtained from the VAS scale (from 1 to 10), these values will be categorized as follows: no pain (0), slight pain (0.1-3.9), moderate pain (4-6.9) or severe pain (7-10)
Measured: Preoperative, 6 hours,12 hours, 24 hours, 48 hours, 72 hours, 5 days and 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start15 May 2023
- Primary completion28 Feb 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontically Treated TeethStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajman University
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat Internacional de Catalunya
- Responsible party
- Principal investigator, Firas Elmsmari, Ajman University
- Investigators
- Firas H Elmsmari, PhD, Principal investigator, Ajman University - College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134713
- Sponsor's protocol ID
- D-F-H-30-NOV
- Status last verified
- Nov 2023
- First submitted
- 4 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intra-Canal Cryotherapy on Post Operative Pain After Primary and Secondary Root Canal Treatment: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06134713
- Acronym / sponsor ID
- D-F-H-30-NOV
- Conditions
- Endodontically Treated Teeth, Post Operative Pain
- Keywords
- Root Canal Treatment, Post Operative Pain, Cryotherapy, Nonsurgical Root Canal Retreatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ajman UniversityUniversity, hospital or other
- Collaborators
- Universitat Internacional de Catalunya
- Study start
- 15 May 2023 (actual)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 18 Nov 2023 (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.
The goal of this randomised clinical trial is to evaluate the effect of cryotherapy on postoperative pain after primary and secondary root canal treatment. The main question[s] it aims to answer are:
- Dose cryotherapy help reduce postoperative pain after primary root canal treatment.
- Dose cryotherapy help reduce postoperative pain after secondary root canal treatment.
Participants will be randomly divided to receive either cryotherapy or irrigation with normal saline and the effect between the two groups in terms of postoperative pain will be compared after primary and secondary root canal treatment.
Detailed description
Procedure
Previous pain assessment:
Both pre- and postoperative pain will be assessed using Huskinsson's visual analog scale (VAS). According to the quantitative data obtained from the VAS scale, these values are categorized as follows: no pain (0), slight pain (0.1-3.9), moderate pain (4-6.9) or pain severe (7-10).
Informed consent After the procedure is carefully explained to the patient and the patient has accepted the treatment plan and signed the Consent, they will be included in the study. Students will give a complete explanation of the study, the forms of pain and how to properly fill out the pain form. If the patient wishes to participate, they will sign the document in order to continue with the treatment and be included in the study.
Root canal treatment and retreatment Vitality test which includes cold test using Endo Ice (Coltene, Switzerland) and Electrical pulp test (EPT) (Shadental, India) for cases of primary root canal treatment. Vertical and lateral percussion tests, periodontal probing, and periapical and bitewing radiographs will be performed in order to perform the pulpal and periapical diagnosis.
The general treatment protocol will be the same for all groups. In case of primary root canal treatment, after the clinical examination, the cold test (Endo-Frost, Coltene-Whaledent, Langenau, Germany) will be used to determine the vitality of the pulp, which will be verified by the presence or absence of bleeding from the root canals during the preparation of the pulp endodontic access.
Local infiltration with 2% lidocaine with epinephrine 1: 80,000 (Ultracain, Normon) will be performed, and absolute isolation with a rubber dam and the department's endodontic protocol will be followed. Access cavity with sterile round diamond drills and Endo-Z drills (Dentsply Maillefer, Ballaigues, Switzerland). The working length (WL) is established with a #10 K-file and apex locator and confirmed with a periapical radiograph. In case of secondary root canal treatment, gutta percha removal and disobturation will be done using different types of rotary and manual files and canals will be negotiated till patency is achieved in all canals, if patency is not achieved the case will be excluded from the study. After which for both primary and secondary root canal treatment instrumentation of the canals will be performed in which they will be irrigated with 1.3% NaOCl solution using a plastic syringe and side-exit needle (Max-i-probe, Kerr-Hawe, Bioggio, Switzerland). Apical patency will be maintained throughout the procedure. Once the procedure is complete, 1 ml of 17% EDTA will be used and a final irrigation with 1.3% NaOCl will be performed with ultrasonic activation using the Irrisafe tip (Acteon, UK).
In the control group, a final irrigation will be performed with 5 ml of 0.9% physiological saline (Sodium Chloride IV infusion 0.9% (Gulf Inject LLC)) at room temperature and in the experimental group with the saline at 2.5ºC for 4 minutes with an endo needle inserted at working length. The saline solution for the control group will be kept at room temperature. The saline solution of the experimental groups will be kept in a refrigerator set at 2.5 C until clinical use.
- Group 1: Conventional root canal treatment with final irrigation with saline at room temperature (n=30).
- Group 2: Conventional root canal retreatment with final irrigation with saline at room temperature (n=30).
- Group 3: Conventional root canal treatment with final irrigation with saline at 2.5ºC for 4 minutes (n=30).
- Group 2: Conventional root canal retreatment with final irrigation with saline at 2.5ºC for 4 minutes (n=30).
The canals will be dried with paper points. The canals of both groups will be filled using a warm gutta-percha filling technique. AH-Plus cement (Dentsply, DeTrey GmbH, Konstanz, Germany) will be used as root canal sealer. Each coronal access will be sealed with a flowable resin (Tetric, IvoclarVivadent AG, SchaanFurstentum, Liechtenstein) and the access cavity will be filled with Glass Ionomer Cement (GIC, ESPE dental, Seefeld, Germany).
Post-operative pain assessment A sheet will be given to the patient with different lines of VAS so that the patient reports the intensity of pain or its absence in the same way that he has been previously taught with preoperative pain at 8, 24 and 48h, 7 days. An ibuprofen 600 mg every 8-12 hours will be recommended for pain control when necessary. The type of analgesic, its quantity and dose will also be recorded in the event that the patients take any type of medication. Patients will be asked to return the VAS collection sheet at the next restoration or general treatment plan continuation visit at the University Clinic. Both the preoperative and postoperative pain results recorded on the Huskinsson VAS scale will be measured by an operator independent of the study, who will be previously calibrated, teaching the evaluator to measure 10 times with a ruler the distance between the initial point of the line to the point marked by the patient on it.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Root canal treatment cryotherapy group | Experimental | Drug: cryotherapy with sterile saline at 2.5ºCConventional root canal treatment with final irrigation using sterile saline at 2.5ºC |
| Root canal RE-treatment cryotherapy group | Experimental | Drug: cryotherapy with sterile saline at 2.5ºCConventional root canal RE-treatment with final irrigation using sterile saline at 2.5ºC |
| Root canal treatment control group | Active comparator | Drug: control with sterile saline at room temperatureConventional root canal treatment with final irrigation using sterile saline at room temperature |
| Root canal RE-treatment control group | Active comparator | Drug: control with sterile saline at room temperatureConventional root canal RE-treatment with final irrigation using sterile saline at room temperature |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients older than 18 years.
- Patients who demonstrate understanding of the study and willingness to participate as evidenced by signing the voluntary informed consent and who received a signed and dated copy of the informed consent form.
- Patients who understand and are willing to comply with all study procedures and restrictions.
- Absence of clinically significant and relevant abnormalities in the clinical history or oral examination.
- Endodontic treatment considered the treatment of choice for both multi and single rooted teeth.
Key exclusion criteria (9 listed)
- Patients who are allergic to any of the materials used in the treatment.
- Patients with heart pacemaker.
- Patients with any general pathology that requires antibiotic prophylaxis.
- Root resorption, root fractures, impossibility of restoration.
- Pregnant patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cryotherapy with sterile saline at 2.5ºCIn the cryotherapy (experimental group), final irrigation will be performed with 5 ml of 0.9% physiological sterile saline kept refrigerated at 2.5ºC and will be delivered for 1 or 4 minutes with a side vented needle inserted at working length for each canal. | Drug | Root canal RE-treatment cryotherapy group, Root canal treatment cryotherapy group |
| control with sterile saline at room temperatureIn the control group, final irrigation will be performed with 5 ml of 0.9% physiological sterile saline kept at room temperature and will be delivered for 1 or 4 minutes with a side vented needle inserted at working length for each canal. | Drug | Root canal RE-treatment control group, Root canal treatment control group |
Primary outcome
Postoperative pain assessment using the visual analog scale (VAS)
Time frame: Preoperative, 6 hours,12 hours, 24 hours, 48 hours, 72 hours, 5 days and 7 days
Both pre- and postoperative pain will be assessed using the visual analog scale (VAS). According to the quantitative data obtained from the VAS scale (from 1 to 10), these values will be categorized as follows: no pain (0), slight pain (0.1-3.9), moderate pain (4-6.9) or severe pain (7-10)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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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.
Firas H Elmsmari, PhD principal investigator
Ajman University - College of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cryotherapy with sterile saline at 2.5ºC in people with Endodontically Treated Teeth and Post Operative Pain, run by Ajman University at 1 site in United Arab Emirates.
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 7 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 18 Nov 2023. 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 United Arab Emirates. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Postoperative pain assessment using the visual analog scale (VAS) (time frame: Preoperative, 6 hours,12 hours, 24 hours, 48 hours, 72 hours, 5 days and 7 days). 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 18 Nov 2023.