Teeth With Acute Irreverseble PulpitisEarly Phase 1NCT06500871
Evaluation of the Effect of Intra-ligamentary Injection of Diclofenac Potassium Versus Articaine on Anaesthetic Efficacy in Mandibular Molars With Symptomatic Irreversible Pulpitis.
A Early Phase 1 study testing Diclofenac Potassium in people with Teeth With Acute Irreverseble Pulpitis, run by Cairo University.
Trial summary
This study aims to assess the effect the intraligamentary injection of Diclofenac Potassium versus Articaine 4% on the anaesthetic efficacy \& intensity of intraoperative \& postoperative pain during single visit root canal treatment in patients with symptomatic irreversible pulpitis in mandibular molar teeth Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Teeth With Acute Irreverseble Pulpitis
- What is being tested?
- Diclofenac Potassium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Jul 2025
- Phase
- Early Phase 1
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy patient (ASA I or II).
- Mandibular Posterior teeth with:
- Preoperative sharp pain, Absence or slight widening in the periodontal ligament (PDL), Vital response of pulp tissue to cold pulp test.
- patients who agree to provide written consent and the patients able to understand the pain scale and attend for recall appointments
Who cannot join
- Patients allergic to anesthetic solutions \& other NSAIDs.
- Pregnant or nursing females.
- Patients having significant systemic disorder (ASA III or IV).
- Gastrointestinal disorders.
- If the initial diagnosis revealed pain in more than one tooth.
- Hemostatic disorders or anti-coagulant therapy during the last month.
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- Consumption of opioid or non-opioid analgesics or NSAIDs during the last 12 hours before treatment.
- Teeth that have:
- Periodontal involvement (with pocket depth greater than 5mm, associated with swelling or fistulous tract, or greater than grade I mobility).
- No possible restorability. iii.Signs of pulpal necrosis; associated sinus tract or swelling.
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the Effect of Intra-ligamentary Injection of Diclofenac Potassium Versus Articaine on Anaesthetic Efficacy in Mandibular Molars With Symptomatic Irreversible Pulpitis:A Randomized Controlled Trial
This study aims to assess the effect the intraligamentary injection of Diclofenac Potassium versus Articaine 4% on the anaesthetic efficacy \& intensity of intraoperative \& postoperative pain during single visit root canal treatment in patients with symptomatic irreversible pulpitis in mandibular molar teeth
- Conditions
- Teeth With Acute Irreverseble Pulpitis
- Being tested
- Diclofenac Potassium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac PotassiumDrug
NSAID
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac Potassium | Experimental | 0.4 ml diclofena potassium injection 75mg/3ml drug used as Supplemental intraligamentary injection Receives: Drug: Diclofenac Potassium |
| Articaine Anaesthetic solution | Active comparator | Articaine 4% with (1:100,000 Epinephrine) local anesthetic solution will be used as intraligamentary injection, Receives: Drug: Diclofenac Potassium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of local anesthesia
using Heft parker Visual Analogue scale Binary where success is defined as no pain or faint/weak /mild pain<55 mm). if >55 defined as failure
Measured: intraoperative ( access cavity preparation & instrumentation ) during root canal treatment
Secondary outcomes (3)
Intensity of intraoperative pain
using Heft parker Visual analogue scale score ranges from on a 170-mm VAS line with the ends labeled "no pain" and "unbearable pain. .no pain (< 5 mm), mild pain (≥ 5 mm and ≤ 54 mm), Moderate pain (> 54 mm and < 114 mm), Severe pain (≥ 114 mm).
Measured: intraoperative ( access cavity preparation & instrumentation ) during root canal treatment
Post-operative pain
using Heft parker Visual analogue scale on a 170-mm VAS line with the ends labeled "no pain" and "unbearable pain. .no pain (< 5 mm), mild pain (≥ 5 mm and ≤ 54 mm), Moderate pain (> 54 mm and < 114 mm), Severe pain (≥ 114 mm).
Measured: 6, 12, 24 and 48 hours post-operatively
Number of needed analgesic tablets in case of intolerable pain
by counting
Measured: Up to 2 days post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study startAug 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Teeth With Acute Irreverseble PulpitisStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Abdou Ibraheem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500871
- Sponsor's protocol ID
- ENDO 9-1-2
- Status last verified
- Aug 2024
- First submitted
- 8 Jul 2024
- Last updated
- 6 Aug 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 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Intra-ligamentary Injection of Diclofenac Potassium Versus Articaine on Anaesthetic Efficacy in Mandibular Molars With Symptomatic Irreversible Pulpitis:A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06500871
- Acronym / sponsor ID
- ENDO 9-1-2
- Conditions
- Teeth With Acute Irreverseble Pulpitis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 15 Jul 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.
This study aims to assess the effect the intraligamentary injection of Diclofenac Potassium versus Articaine 4% on the anaesthetic efficacy \& intensity of intraoperative \& postoperative pain during single visit root canal treatment in patients with symptomatic irreversible pulpitis in mandibular molar teeth
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diclofenac Potassium | Experimental | Drug: Diclofenac Potassium0.4 ml diclofena potassium injection 75mg/3ml drug used as Supplemental intraligamentary injection |
| Articaine Anaesthetic solution | Active comparator | Drug: Diclofenac PotassiumArticaine 4% with (1:100,000 Epinephrine) local anesthetic solution will be used as intraligamentary injection, |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Systemically healthy patient (ASA I or II).
- Mandibular Posterior teeth with:
- Preoperative sharp pain, Absence or slight widening in the periodontal ligament (PDL), Vital response of pulp tissue to cold pulp test.
- patients who agree to provide written consent and the patients able to understand the pain scale and attend for recall appointments
Key exclusion criteria (11 listed)
- Patients allergic to anesthetic solutions \& other NSAIDs.
- Pregnant or nursing females.
- Patients having significant systemic disorder (ASA III or IV).
- Gastrointestinal disorders.
- If the initial diagnosis revealed pain in more than one tooth.
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 |
|---|---|---|
| Diclofenac PotassiumNSAID | Drug | Articaine Anaesthetic solution, Diclofenac Potassium |
Primary outcome
Efficacy of local anesthesia
Time frame: intraoperative ( access cavity preparation & instrumentation ) during root canal treatment
using Heft parker Visual Analogue scale Binary where success is defined as no pain or faint/weak /mild pain<55 mm). if >55 defined as failure
3 secondary outcomes
Intensity of intraoperative pain
Time frame: intraoperative ( access cavity preparation & instrumentation ) during root canal treatment
Post-operative pain
Time frame: 6, 12, 24 and 48 hours post-operatively
Number of needed analgesic tablets in case of intolerable pain
Time frame: Up to 2 days post operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Diclofenac Potassium in people with Teeth With Acute Irreverseble Pulpitis, 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 4 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: status not confirmed, as of the sponsor's last update on 6 Aug 2024. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Contact Mai Eldeeb, master (01093738532, mai.eldeeb@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of local anesthesia (time frame: intraoperative ( access cavity preparation & instrumentation ) during root canal treatment). 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 6 Aug 2024.