Pulpitis - IrreversiblePhase 4NCT06330519
Enhancing Anaesthetic Success in Mandibular Molars With Symptomatic Irreversible Pulpitis: A Comparative Randomized Controlled Trial
A Phase 4 study testing Dexamethasone sodium phosphate injection, 1,1,1,2 tetrafluoroethane and intraoral soft tissue cryotherapy in people with Pulpitis - Irreversible, run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to assess the effect of Preoperative intraligamentary corticosteroids injection Cryotherapy which is cold application on : Hard tooth structure ( crown of the tooth ) Soft tissue overlying roots on the efficacy of the inferior alveolar nerve block anaesthesia in patients with… Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis - Irreversible
- What is being tested?
- Dexamethasone sodium phosphate injection, 1,1,1,2 tetrafluoroethane and intraoral soft tissue cryotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 30 Mar 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 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants willing to commit for the entire period of the trial and agreed to sign the written consent after full explanation of the study.
- Having a mandibular molar tooth diagnosed with symptomatic irreversible pulpitis (hot tooth - vital pulp, intermittent or continuous sharp pain that lasts longer after removal of the stimulus).
Who cannot join
- Presence of any systemic disease or allergic reactions.
- Vulnerable group; prisoners, pregnant females, mentally ill, etc…
- The presence of a periapical radiolucency.
- Teeth with open apices.
- A previous root canal treatment.
- Sinus tracts.
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- Local gum swelling around the affected tooth.
- Severe periodontal disease .
- Presence of periodontal pockets >3 mm in the affected tooth.
- Absence of bleeding in the pulp chamber on access cavity preparation.
- Patients with doubted diagnosis due to multiple carious teeth.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Impact of Different Techniques on the Efficacy of Anaesthesia in Mandibular Molars With Acute Irreversible Pulpitis: A Randomized Controlled Trial"
The goal of this clinical trial is to assess the effect of
- Preoperative intraligamentary corticosteroids injection
- Cryotherapy which is cold application on :
- Hard tooth structure ( crown of the tooth )
- Soft tissue overlying roots on the efficacy of the inferior alveolar nerve block anaesthesia in patients with mandibular molars with symptomatic irreversible pulpitis. The main question it aims to answer are: • Does intraligamentary dexamethazone injection increase the success rate of inferior alveolar nerve block without the need for oral premedication.
Read more
Participants will describe their preoperative pain level to the investigator and describe their pain level during the treatment.
Researchers will compare cryotherapy to see if it increases the success rate of inferior alveolar nerve block.
- Conditions
- Pulpitis - Irreversible
- Being tested
- Dexamethasone sodium phosphate injection, 1,1,1,2 tetrafluoroethane, intraoral soft tissue cryotherapy
- Keywords
- dexamethasone, intraligamentary, cryotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone sodium phosphate injectionDrug
Patients receive 0.8ml of dexamethazone by periodontal ligament injection 30 minutes before the inferior alveolar nerve block
1,1,1,2 tetrafluoroethaneOther
Also called Endo-ice
EndoIce (1,1,1,2 tetrafluoroethane) applied on the buccal, lingual (3 s/surface), and occlusal surfaces (4 s) for a total of 10 s then standard IANB was administered
intraoral soft tissue cryotherapyOther
Small ice packs (wrapped in sterile gauze) placed intraorally in the mouth on the vestibular surface of the treated tooth for 5 minutes then standard IANB was administered
| Study group | Role | What they receive |
|---|---|---|
| intraligamentary dexamethazone | Experimental | Not described Receives: Drug: Dexamethasone sodium phosphate injection |
| Endo-ice cryotherapy | Active comparator | Not described Receives: Other: 1,1,1,2 tetrafluoroethane |
| Intraoral soft tissue cryotherapy | Active comparator | Not described Receives: Other: intraoral soft tissue cryotherapy |
| Inferior Alveolar nerve block only | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of intraligamentary dexamethazone injection on the success rate of inferior alveolar nerve block
Percentage of the successful participants among total participants
Measured: Assessed up to 30 minutes, from lip numbness point until the end of pulp extirpation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start1 Feb 2023
- Primary completion1 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulpitis - IrreversibleStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330519
- Sponsor's protocol ID
- Ainshams University Dentistry
- Status last verified
- Mar 2024
- First submitted
- 8 Mar 2024
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Impact of Different Techniques on the Efficacy of Anaesthesia in Mandibular Molars With Acute Irreversible Pulpitis: A Randomized Controlled Trial"
- ClinicalTrials.gov ID
- NCT06330519
- Acronym / sponsor ID
- Ainshams University Dentistry
- Conditions
- Pulpitis - Irreversible
- Keywords
- dexamethasone, intraligamentary, cryotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 26 Mar 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.
The goal of this clinical trial is to assess the effect of
- Preoperative intraligamentary corticosteroids injection
- Cryotherapy which is cold application on :
- Hard tooth structure ( crown of the tooth )
- Soft tissue overlying roots on the efficacy of the inferior alveolar nerve block anaesthesia in patients with mandibular molars with symptomatic irreversible pulpitis. The main question it aims to answer are: • Does intraligamentary dexamethazone injection increase the success rate of inferior alveolar nerve block without the need for oral premedication.
Participants will describe their preoperative pain level to the investigator and describe their pain level during the treatment.
Researchers will compare cryotherapy to see if it increases the success rate of inferior alveolar nerve block.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| intraligamentary dexamethazone | Experimental | Drug: Dexamethasone sodium phosphate injection |
| Endo-ice cryotherapy | Active comparator | Other: 1,1,1,2 tetrafluoroethane |
| Intraoral soft tissue cryotherapy | Active comparator | Other: intraoral soft tissue cryotherapy |
| Inferior Alveolar nerve block only | No intervention | – |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Participants willing to commit for the entire period of the trial and agreed to sign the written consent after full explanation of the study.
- Having a mandibular molar tooth diagnosed with symptomatic irreversible pulpitis (hot tooth - vital pulp, intermittent or continuous sharp pain that lasts longer after removal of the stimulus).
Key exclusion criteria (11 listed)
- Presence of any systemic disease or allergic reactions.
- Vulnerable group; prisoners, pregnant females, mentally ill, etc…
- The presence of a periapical radiolucency.
- Teeth with open apices.
- A previous root canal treatment.
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 |
|---|---|---|
| Dexamethasone sodium phosphate injectionPatients receive 0.8ml of dexamethazone by periodontal ligament injection 30 minutes before the inferior alveolar nerve block | Drug | intraligamentary dexamethazone |
| 1,1,1,2 tetrafluoroethaneAlso: Endo-iceEndoIce (1,1,1,2 tetrafluoroethane) applied on the buccal, lingual (3 s/surface), and occlusal surfaces (4 s) for a total of 10 s then standard IANB was administered | Other | Endo-ice cryotherapy |
| intraoral soft tissue cryotherapySmall ice packs (wrapped in sterile gauze) placed intraorally in the mouth on the vestibular surface of the treated tooth for 5 minutes then standard IANB was administered | Other | Intraoral soft tissue cryotherapy |
Primary outcome
The effect of intraligamentary dexamethazone injection on the success rate of inferior alveolar nerve block
Time frame: Assessed up to 30 minutes, from lip numbness point until the end of pulp extirpation.
Percentage of the successful participants among total participants
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 9 May 2025.
- Individual participant dataSharing planned: Undecided
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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 Phase 4 study testing Dexamethasone sodium phosphate injection, 1,1,1,2 tetrafluoroethane and intraoral soft tissue cryotherapy in people with Pulpitis - Irreversible, 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 2 inclusion and 11 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 9 May 2025. 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.
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?
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 effect of intraligamentary dexamethazone injection on the success rate of inferior alveolar nerve block (time frame: Assessed up to 30 minutes, from lip numbness point until the end of pulp extirpation.). 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 9 May 2025.