Pulpitis - IrreversibleNCT05928611
Intraligmentary Dexamethasone in Lower First Molars With Irreversible Pulpitis and Apical Periodontits
A study testing Inferior alveolar nerve block with dexamethasone, Buccal infiltratation with dexamethasone and Inferior alveolar nerve block in people with Pulpitis - Irreversible, run by Cairo University.
Trial summary
Using intraligmentary dexamethasone to reduce the pain intensity during and after root canal preparation Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis - Irreversible
- What is being tested?
- Inferior alveolar nerve block with dexamethasone, Buccal infiltratation with dexamethasone and Inferior alveolar nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to Sep 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 20-45 years old.
- Systemically healthy patient (ASA I or II).
- Lower first molar with:
- Preoperative sharp pain.
- Slight widening in the periodontal ligament (PDL).
- Vital response of pulp tissue to cold pulp tester (ethyl chloride spray).
Who cannot join
- Patients allergic to anesthetics, or dexamethasone (other corticosteroids).
- Pregnant or nursing females.
- Patients having significant systemic disorder (ASA III or IV).
- Hemostatic disorders or anti-coagulant therapy during the last month.
- Consumption of opioid or non-opioid analgesics or corticosteroids during the last 12 h before treatment.
- Retreatment cases.
Trial locations and contacts
No sites are listed yet.
Mohamed M Abi Elhassan, Phd contact
About this study
Official title: Effect of Intraligmentary Dexamethasone on Anesthetic Efficacy of Inferior Alveolar Nerve Block Versus Buccal Infiltratation in Lower First Molars With Irreversible Pulpitis and Apical Periodontits: A Randomized Clinical Trial
Using intraligmentary dexamethasone to reduce the pain intensity during and after root canal preparation
Read the detailed description
Aim :asseing the effect of intraligmentary dexamethasone on anesthetic efficacy of inferior alveolar nerve block and buccal infiltratation in lower first molar with irreversible pulpitis and apical periodontits, dexamethasone has antiinflammatory effect so it will improve the efficacy of anathesia and reduce postoperative by inhibition the production of phosopholipase and reduction of prostaglandins synthesis
Methods: diagnose the case clinically and readiographically Patients will divide into 3 groups First group will be given inferior alveolar nerve block 4%articaine Hcl1:100 epinephrine Second group will be given inferior alveolar nerve block 4%articaine with intraligmentary dexamethasone Third group will be given buccal infiltratation 4%articaine with intraligmentary dexamethasone After anathesia ,make access cavity and reduce the occulsa surface and make it out of occulsion .
Working length determination will be done by apex locator and confirm it by x ray .
Mechanical preparation will be done by FANTA files and apply EDTA on files Irrigate the canal by Naocl 2.5٪ Complete the root canal preparation through single visit. Obturate the canal by single cone technique and bioceramic sealer. During procedures , record pain intensity on HP visual scale Follow up the patient after 6,12,24 and 48 hours Describe Ibuprofen 200mg in case of sever pain Conclusion : it's predictable that the intraligmentary dexamethasone will reduce the pain during and after root canal procedures
- Conditions
- Pulpitis - Irreversible
- Being tested
- Inferior alveolar nerve block with dexamethasone, Buccal infiltratation with dexamethasone, Inferior alveolar nerve block
- Keywords
- " irreversible pulpitis with apical periodontitis"
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inferior alveolar nerve block with dexamethasoneProcedure or surgery
Using articaine for inferior alveolar block with intraligmentary dexamethasone
Buccal infiltratation with dexamethasoneProcedure or surgery
Using articaine for buccal infiltratation with intraligmentary dexamethasone
Inferior alveolar nerve blockProcedure or surgery
Using articaine for injection
| Study group | Role | What they receive |
|---|---|---|
| Inferior alveolar nerve block | Active comparator | Using 1.8ml of 4% articaine HCL 1:100,000 epinehrine Receives: Procedure: Inferior alveolar nerve block |
| Inferior alveolar nerve block with intraligmentary dexamethasone | Experimental | Using 1.8ml of 4% articaine HCL 1:100,000 epinehrine for inferior alveolar nerve block and 0.4 mL of 8 mg/ 2mLdexamethasone for intraligmentary injection Receives: Procedure: Inferior alveolar nerve block with dexamethasone |
| Buccal infiltratation with intraligmentary dexamethasone | Experimental | Using 1.8ml of 4% articaine HCL 1:100,000 epinehrine for buccal infiltratation and 0.4 mL of 8 mg/ 2mLdexamethasone for intraligmentary injection Receives: Procedure: Buccal infiltratation with dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative pain
Efficacy of buccal infiltration anesthesia and inferior alveolar nerve block measured during procedures of root canal treatment using numerical rating scale.It is a line numbered from 0-10 , where pain levels are categorized as follows: 0= no pain, 1-3 = mild pain, 4-6= moderate pain, 7-10= severe pain, "10" being the most intense pain conceivable.And instruct patient to raise his hand if he feels pain to reasse if he needs supplementary anathesia
Measured: During procedure
Secondary outcomes (2)
Post-operative pain
Patient will record the pain on numerical rating scale (6,12,24 \&48h)..It is a line numbered from 0-10 , where pain levels are categorized as follows: 0= no pain, 1-3= mild pain, 4-6= moderate pain, 7-10 = severe pain, "10" being the most intense pain conceivable
Measured: After procedure until 48hour
Number of needed analgesic tablets in case of intolerable pain
Ibuprofen 200mgm tabs have been described to patient in case of sever pain (above6)
Measured: After procedure until 48hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study startAug 2023 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionSep 2024 (estimated)
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 Cairo 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
- Masking
- None (open label)
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wafaa Rezk Elshafaey, Cairo University
- Investigators
- Angie G Ghoneim, Study director, Faculty of oral and dental medicine,Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928611
- Sponsor's protocol ID
- ENDO 3 - 3 - 5
- Status last verified
- Jul 2023
- First submitted
- 15 Jun 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraligmentary Dexamethasone on Anesthetic Efficacy of Inferior Alveolar Nerve Block Versus Buccal Infiltratation in Lower First Molars With Irreversible Pulpitis and Apical Periodontits: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05928611
- Acronym / sponsor ID
- ENDO 3 - 3 - 5
- Conditions
- Pulpitis - Irreversible
- Keywords
- " irreversible pulpitis with apical periodontitis"
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 3 Jul 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.
Using intraligmentary dexamethasone to reduce the pain intensity during and after root canal preparation
Detailed description
Aim :asseing the effect of intraligmentary dexamethasone on anesthetic efficacy of inferior alveolar nerve block and buccal infiltratation in lower first molar with irreversible pulpitis and apical periodontits, dexamethasone has antiinflammatory effect so it will improve the efficacy of anathesia and reduce postoperative by inhibition the production of phosopholipase and reduction of prostaglandins synthesis
Methods: diagnose the case clinically and readiographically Patients will divide into 3 groups First group will be given inferior alveolar nerve block 4%articaine Hcl1:100 epinephrine Second group will be given inferior alveolar nerve block 4%articaine with intraligmentary dexamethasone Third group will be given buccal infiltratation 4%articaine with intraligmentary dexamethasone After anathesia ,make access cavity and reduce the occulsa surface and make it out of occulsion .
Working length determination will be done by apex locator and confirm it by x ray .
Mechanical preparation will be done by FANTA files and apply EDTA on files Irrigate the canal by Naocl 2.5٪ Complete the root canal preparation through single visit. Obturate the canal by single cone technique and bioceramic sealer. During procedures , record pain intensity on HP visual scale Follow up the patient after 6,12,24 and 48 hours Describe Ibuprofen 200mg in case of sever pain Conclusion : it's predictable that the intraligmentary dexamethasone will reduce the pain during and after root canal procedures
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inferior alveolar nerve block | Active comparator | Procedure: Inferior alveolar nerve blockUsing 1.8ml of 4% articaine HCL 1:100,000 epinehrine |
| Inferior alveolar nerve block with intraligmentary dexamethasone | Experimental | Procedure: Inferior alveolar nerve block with dexamethasoneUsing 1.8ml of 4% articaine HCL 1:100,000 epinehrine for inferior alveolar nerve block and 0.4 mL of 8 mg/ 2mLdexamethasone for intraligmentary injection |
| Buccal infiltratation with intraligmentary dexamethasone | Experimental | Procedure: Buccal infiltratation with dexamethasoneUsing 1.8ml of 4% articaine HCL 1:100,000 epinehrine for buccal infiltratation and 0.4 mL of 8 mg/ 2mLdexamethasone for intraligmentary injection |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 20-45 years old.
- Systemically healthy patient (ASA I or II).
- Lower first molar with:
Key exclusion criteria (6 listed)
- Patients allergic to anesthetics, or dexamethasone (other corticosteroids).
- Pregnant or nursing females.
- Patients having significant systemic disorder (ASA III or IV).
- Hemostatic disorders or anti-coagulant therapy during the last month.
- Consumption of opioid or non-opioid analgesics or corticosteroids during the last 12 h before 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 |
|---|---|---|
| Inferior alveolar nerve block with dexamethasoneUsing articaine for inferior alveolar block with intraligmentary dexamethasone | Procedure or surgery | Inferior alveolar nerve block with intraligmentary dexamethasone |
| Buccal infiltratation with dexamethasoneUsing articaine for buccal infiltratation with intraligmentary dexamethasone | Procedure or surgery | Buccal infiltratation with intraligmentary dexamethasone |
| Inferior alveolar nerve blockUsing articaine for injection | Procedure or surgery | Inferior alveolar nerve block |
Primary outcome
Intraoperative pain
Time frame: During procedure
Efficacy of buccal infiltration anesthesia and inferior alveolar nerve block measured during procedures of root canal treatment using numerical rating scale.It is a line numbered from 0-10 , where pain levels are categorized as follows: 0= no pain, 1-3 = mild pain, 4-6= moderate pain, 7-10= severe pain, "10" being the most intense pain conceivable.And instruct patient to raise his hand if he feels pain to reasse if he needs supplementary anathesia
2 secondary outcomes
Post-operative pain
Time frame: After procedure until 48hour
Number of needed analgesic tablets in case of intolerable pain
Time frame: After procedure until 48hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Mohamed M Abi Elhassan, Phd contact
Angie G Ghoneim study director
Faculty of oral and dental medicine,Cairo university
Questions about this trial
What is this clinical trial studying?
A study testing Inferior alveolar nerve block with dexamethasone, Buccal infiltratation with dexamethasone and Inferior alveolar nerve block in people with Pulpitis - Irreversible, run by Cairo University.
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 6 inclusion and 6 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 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wafaa R Elshafaey (00201020773887, wafaa.elshafaey@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative pain (time frame: During procedure). 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 27 Jul 2023.