Post-endodontic PainNCT06090500
Effect of Submucosal Cryotherapy on Postoperative Endodontic Pain
A study testing Cryotherapy, Diclofenac sodium and Dexamethasone sodium phosphate in people with Post-endodontic Pain, run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare submucosal Cryotherapy with different anti-inflammatory drugs in the reduction of post-endodontic pain in upper premolars with symptomatic irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-endodontic Pain
- What is being tested?
- Cryotherapy, Diclofenac sodium and Dexamethasone sodium phosphate
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2023to 30 Jan 2024
- Phase
- Interventional
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Egyptian healthy both gender patients (Category: American Society of Anesthesiologists ASA class I)
- Patients age (18- 50) years old.
- Maxillary premolar teeth diagnosed with symptomatic irreversible pulpitis.
- No clinical or radiographic evidence of periapical nor periodontal pathosis.
- Compliant patient.
Who cannot join
- The vulnerable group; prisoners, pregnant females, mentally ill, severe systemic diseases, psychological diseases, TMJ problems.
- Analgesics or anti-inflammatory drugs taken within 24 h before the intervention.
- Over instrumentation during treatment.
- Long-term use of corticosteroids.
- Access revealing necrotic tooth indicating a false positive diagnosis.
- Sensitivity to any of the pharmaceuticals intended to be used in this study.
- Intra operative complications such as canal calcification, or loss of apical Patency.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Submucosal Cryotherapy Compared to Steroidal and Non-Steroidal Anti-Inflammatory Drugs Injection on Postoperative Endodontic Pain
The goal of this clinical trial is to compare submucosal Cryotherapy with different anti-inflammatory drugs in the reduction of post-endodontic pain in upper premolars with symptomatic irreversible pulpitis.
The main question it aims to answer is:
Is there is a difference in post-endodontic pain intensity following submucosal cryotherapy or anti-inflammatory drugs injection in patients with symptomatic irreversible pulpitis? Participants will undergo root canal treatment preceded by preoperative injection of cold saline (cryotherapy) or preoperative injection of anti-inflammatory drugs Researchers will compare [Cryotherapy, Non steroidal anti-inflammatory drugs, steroids and no intervention] to see the intensity of post-endodontic pain.
Read the detailed description
The study will be conducted on 52 maxillary premolar teeth; with 13 maxillary premolars in each group (n=13). An independent individual withholding the random allocation sequence, will preoperatively inform a second individual responsible for injection, about the solution required to be injected according to the patient number in the preformed randomized sequence. Triple blinding will be maintained in this study as the operator, the patients and the outcome assessor will not be aware of their group/used sub-mucosal injection.
Group I: (Diclofenac Sodium) submucosal infiltration injection of 1 ml diclofenac sodium (25mg/ml) after the normal local anaesthetic routine.
Group II: (Dexamethasone) Submucosal infiltration injection of 1 ml dexamethasone sodium phosphate (4mg/ml) after the normal local anaesthetic routine..
Group III: (Cryotherapy) Submucosal infiltration injection of 1 mL cryo-treated saline maintained at a temperature of 2 to 5°C after the normal local anaesthetic routine..
Group IV: (Negative control) Patients received no injection apart from the normal local anaesthetic routine.
Procedural steps:
- Vitality will be assessed using cold tests before the procedure is carried out. Besides, mobility, palpation, and percussion tests will be done to assess periapical health. In order to ensure that the cold and electrical pulp tests are working, and a response is elicited, both tests will be carried out on patients not included in the study.
- All the patients will receive local anesthesia: 4% Articaine hydrochloride with 1:100,000 epinephrine.
- In group I submucosal infiltration injection of 1 ml diclofenac sodium (25mg/ml) will be given in the depth of the vestibule 5 minutes after local anesthetic injection.
- In group II submucosal infiltration injection of 1 ml dexamethasone sodium phosphate (4mg/ml) will be given in the depth of the vestibule 5 minutes after local anesthetic injection.
- In group III submucosal infiltration injection of 1 mL (2 to 5°C) cold saline will be given in the depth of the vestibule 5 minutes after local anesthetic injection.
- In group IV regular endodontic treatment starts 5 minutes after local anesthetic injection.
- Each tooth will be isolated using a rubber dam, and the access cavity will be prepared using a tapered diamond stone with rounded end under copious water cooling.
- After removal of coronal pulp tissues using a sterile excavator, the working length will be determined with stainless steel hand K-files size #10 and the use of an apex locator and confirmed using intraoral periapical radiographs.
- Hand instrumentation to 15-size K files.
- All the canals will be prepared using M-Pro Gold rotary files till the master apical file.
- Apical patency will be maintained throughout the shaping procedure using the #10 file between each instrument.
- All the canals will be irrigated with 10 mL of 5.25% NaOCl between each file during the whole preparation procedure.
- After completion of cleaning and shaping canals will be dried using appropriate size paper points and obturated using gutta-percha with cold lateral technique, then restored by temporary restoration
- Conditions
- Post-endodontic Pain
- Being tested
- Cryotherapy, Diclofenac sodium, Dexamethasone sodium phosphate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyProcedure or surgery
preoperative submucosal infiltration injection of cold saline solution (2-5 degrees Celsius)
Diclofenac sodiumProcedure or surgery
preoperative submucosal infiltration injection of Diclofenac sodium (25mg/ml)
Dexamethasone sodium phosphateProcedure or surgery
preoperative submucosal infiltration injection of dexamethasone sodium phosphate (4mg/ml)
| Study group | Role | What they receive |
|---|---|---|
| Submucosal Cryotherapy | Experimental | preoperative submucosal infiltration injection of (2.5C-5C) cold saline Receives: Procedure: Cryotherapy |
| Submucosal NSAIDs | Active comparator | preoperative submucosal infiltration injection of Diclofenac sodium Receives: Procedure: Diclofenac sodium |
| Submucosal corticosteroids | Active comparator | preoperative submucosal infiltration injection of dexamethasone Receives: Procedure: Dexamethasone sodium phosphate |
| Control | No intervention | no preoperative injection apart from the normal anaesthetic routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the level of post-endodontic pain
Evaluation of the pain intensity using the Numeric Rating Scale. The Numeric Rating Scale measures pain intensity. Numeric Rating Scale consists of scores ranged from 0-10,with lowest 0 as lowest score representing ('no pain') and 10 as highest score representing ('pain as bad as it could possibly be)
Measured: 6 hours after completion of endodontic treatment
the level of post-endodontic pain
Evaluation of the pain intensity using the Numeric Rating Scale. The Numeric Rating Scale measures pain intensity. Numeric Rating Scale consists of scores ranged from 0-10,with lowest 0 as lowest score representing ('no pain') and 10 as highest score representing ('pain as bad as it could possibly be)
Measured: 24 hours after completion of endodontic treatment
the level of post-endodontic pain
Evaluation of the pain intensity using the Numeric Rating Scale. The Numeric Rating Scale measures pain intensity. Numeric Rating Scale consists of scores ranged from 0-10,with lowest 0 as lowest score representing ('no pain') and 10 as highest score representing ('pain as bad as it could possibly be)
Measured: 48 hours after completion of endodontic treatment
the level of post-endodontic pain
Evaluation of the pain intensity using the Numeric Rating Scale. The Numeric Rating Scale measures pain intensity. Numeric Rating Scale consists of scores ranged from 0-10,with lowest 0 as lowest score representing ('no pain') and 10 as highest score representing ('pain as bad as it could possibly be)
Measured: 72 hours after completion of endodontic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start20 Mar 2023
- Primary completion5 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-endodontic PainStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- submucosal injection of cold saline 2 to 5 degrees celsius for cryotherapy
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Shalabi, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090500
- Sponsor's protocol ID
- FDASU 1234
- Status last verified
- Feb 2024
- First submitted
- 10 Oct 2023
- Last updated
- 8 Feb 2024
- 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 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Submucosal Cryotherapy Compared to Steroidal and Non-Steroidal Anti-Inflammatory Drugs Injection on Postoperative Endodontic Pain
- ClinicalTrials.gov ID
- NCT06090500
- Acronym / sponsor ID
- FDASU 1234
- Conditions
- Post-endodontic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 19 Oct 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 clinical trial is to compare submucosal Cryotherapy with different anti-inflammatory drugs in the reduction of post-endodontic pain in upper premolars with symptomatic irreversible pulpitis.
The main question it aims to answer is:
Is there is a difference in post-endodontic pain intensity following submucosal cryotherapy or anti-inflammatory drugs injection in patients with symptomatic irreversible pulpitis? Participants will undergo root canal treatment preceded by preoperative injection of cold saline (cryotherapy) or preoperative injection of anti-inflammatory drugs Researchers will compare [Cryotherapy, Non steroidal anti-inflammatory drugs, steroids and no intervention] to see the intensity of post-endodontic pain.
Detailed description
The study will be conducted on 52 maxillary premolar teeth; with 13 maxillary premolars in each group (n=13). An independent individual withholding the random allocation sequence, will preoperatively inform a second individual responsible for injection, about the solution required to be injected according to the patient number in the preformed randomized sequence. Triple blinding will be maintained in this study as the operator, the patients and the outcome assessor will not be aware of their group/used sub-mucosal injection.
Group I: (Diclofenac Sodium) submucosal infiltration injection of 1 ml diclofenac sodium (25mg/ml) after the normal local anaesthetic routine.
Group II: (Dexamethasone) Submucosal infiltration injection of 1 ml dexamethasone sodium phosphate (4mg/ml) after the normal local anaesthetic routine..
Group III: (Cryotherapy) Submucosal infiltration injection of 1 mL cryo-treated saline maintained at a temperature of 2 to 5°C after the normal local anaesthetic routine..
Group IV: (Negative control) Patients received no injection apart from the normal local anaesthetic routine.
Procedural steps:
- Vitality will be assessed using cold tests before the procedure is carried out. Besides, mobility, palpation, and percussion tests will be done to assess periapical health. In order to ensure that the cold and electrical pulp tests are working, and a response is elicited, both tests will be carried out on patients not included in the study.
- All the patients will receive local anesthesia: 4% Articaine hydrochloride with 1:100,000 epinephrine.
- In group I submucosal infiltration injection of 1 ml diclofenac sodium (25mg/ml) will be given in the depth of the vestibule 5 minutes after local anesthetic injection.
- In group II submucosal infiltration injection of 1 ml dexamethasone sodium phosphate (4mg/ml) will be given in the depth of the vestibule 5 minutes after local anesthetic injection.
- In group III submucosal infiltration injection of 1 mL (2 to 5°C) cold saline will be given in the depth of the vestibule 5 minutes after local anesthetic injection.
- In group IV regular endodontic treatment starts 5 minutes after local anesthetic injection.
- Each tooth will be isolated using a rubber dam, and the access cavity will be prepared using a tapered diamond stone with rounded end under copious water cooling.
- After removal of coronal pulp tissues using a sterile excavator, the working length will be determined with stainless steel hand K-files size #10 and the use of an apex locator and confirmed using intraoral periapical radiographs.
- Hand instrumentation to 15-size K files.
- All the canals will be prepared using M-Pro Gold rotary files till the master apical file.
- Apical patency will be maintained throughout the shaping procedure using the #10 file between each instrument.
- All the canals will be irrigated with 10 mL of 5.25% NaOCl between each file during the whole preparation procedure.
- After completion of cleaning and shaping canals will be dried using appropriate size paper points and obturated using gutta-percha with cold lateral technique, then restored by temporary restoration
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- submucosal injection of cold saline 2 to 5 degrees celsius for cryotherapy
| Arm | Type | Receives |
|---|---|---|
| Submucosal Cryotherapy | Experimental | Procedure: Cryotherapypreoperative submucosal infiltration injection of (2.5C-5C) cold saline |
| Submucosal NSAIDs | Active comparator | Procedure: Diclofenac sodiumpreoperative submucosal infiltration injection of Diclofenac sodium |
| Submucosal corticosteroids | Active comparator | Procedure: Dexamethasone sodium phosphatepreoperative submucosal infiltration injection of dexamethasone |
| Control | No intervention | –no preoperative injection apart from the normal anaesthetic routine |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Egyptian healthy both gender patients (Category: American Society of Anesthesiologists ASA class I)
- Patients age (18- 50) years old.
- Maxillary premolar teeth diagnosed with symptomatic irreversible pulpitis.
- No clinical or radiographic evidence of periapical nor periodontal pathosis.
- Compliant patient.
Key exclusion criteria (7 listed)
- The vulnerable group; prisoners, pregnant females, mentally ill, severe systemic diseases, psychological diseases, TMJ problems.
- Analgesics or anti-inflammatory drugs taken within 24 h before the intervention.
- Over instrumentation during treatment.
- Long-term use of corticosteroids.
- Access revealing necrotic tooth indicating a false positive diagnosis.
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 |
|---|---|---|
| Cryotherapypreoperative submucosal infiltration injection of cold saline solution (2-5 degrees Celsius) | Procedure or surgery | Submucosal Cryotherapy |
| Diclofenac sodiumpreoperative submucosal infiltration injection of Diclofenac sodium (25mg/ml) | Procedure or surgery | Submucosal NSAIDs |
| Dexamethasone sodium phosphatepreoperative submucosal infiltration injection of dexamethasone sodium phosphate (4mg/ml) | Procedure or surgery | Submucosal corticosteroids |
Primary outcome
the level of post-endodontic pain
Time frame: 6 hours after completion of endodontic treatment
Evaluation of the pain intensity using the Numeric Rating Scale. The Numeric Rating Scale measures pain intensity. Numeric Rating Scale consists of scores ranged from 0-10,with lowest 0 as lowest score representing ('no pain') and 10 as highest score representing ('pain as bad as it could possibly be)
the level of post-endodontic pain
Time frame: 24 hours after completion of endodontic treatment
Evaluation of the pain intensity using the Numeric Rating Scale. The Numeric Rating Scale measures pain intensity. Numeric Rating Scale consists of scores ranged from 0-10,with lowest 0 as lowest score representing ('no pain') and 10 as highest score representing ('pain as bad as it could possibly be)
the level of post-endodontic pain
Time frame: 48 hours after completion of endodontic treatment
Evaluation of the pain intensity using the Numeric Rating Scale. The Numeric Rating Scale measures pain intensity. Numeric Rating Scale consists of scores ranged from 0-10,with lowest 0 as lowest score representing ('no pain') and 10 as highest score representing ('pain as bad as it could possibly be)
the level of post-endodontic pain
Time frame: 72 hours after completion of endodontic treatment
Evaluation of the pain intensity using the Numeric Rating Scale. The Numeric Rating Scale measures pain intensity. Numeric Rating Scale consists of scores ranged from 0-10,with lowest 0 as lowest score representing ('no pain') and 10 as highest score representing ('pain as bad as it could possibly be)
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 8 Feb 2024.
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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.
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?
A study testing Cryotherapy, Diclofenac sodium and Dexamethasone sodium phosphate in people with Post-endodontic Pain, run by Ain Shams University at 1 site in Egypt.
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 5 inclusion and 7 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 8 Feb 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 Egypt. 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?
the level of post-endodontic pain (time frame: 6 hours after completion of endodontic treatment). The study lists 4 primary outcomes in all. 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 8 Feb 2024.