PulpitisNCT06186921
Intraligamentary Injections and Post-endodontic Pain
A study testing Dexamethasone in people with Pulpitis, run by Jamia Millia Islamia at 1 site in India.
Trial summary
This study will aim to evaluate postoperative pain after intraligamentary injections of dexamethasone (4mg/ml), diclofenac sodium (25mg/ml), 0.5% bupivacaine and 2% lidocaine given to the patients with symptomatic irreversible pulpitis after completion of the first appointment. Objectives: 1. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteIndia
- Study dates
- 2 Dec 2023to 3 Mar 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
- Symptomatic carious exposed mandibular first or second molars.
- Positive and prolonged response to thermal sensitivity tests and electric pulp tests.
- Vital coronal pulp on access cavity preparation.
- American Society of Anesthesiologists class I or II medical history.
- Ability to understand the use of pain scales.
Who cannot join
- Active pain in more than 1 tooth
- Teeth with fused roots.
- Radiographic evidence of an extra root.
- Large restorations with overhanging margins.
- Full crowns or deep periodontal pockets.
- Known allergy or contraindications to any content of the local anesthetic solution or NSAIDs
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- History of known or suspected drug abuse.
- Taking any drugs which could affect the pain perception, e.g, opioids, antidepressants, anticonvulsants, muscle relaxants, anxiolytics, sedatives, NSAIDs.
- Pregnant or breastfeeding patients.
- Patients with asthma, gastric ulcers, and bleeding disorders.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Jamia MIliia Islamia
New Delhi, 110025
Vivek Aggarwal, MDS, 01126981818, drvivekaggarwal@gmail.com
About this study
Official title: Effect of Different Intraligamentary Injections on the Post-endodontic Pain in Patients With Symptomatic Irreversible Pulpitis
This study will aim to evaluate postoperative pain after intraligamentary injections of dexamethasone (4mg/ml), diclofenac sodium (25mg/ml), 0.5% bupivacaine and 2% lidocaine given to the patients with symptomatic irreversible pulpitis after completion of the first appointment. Objectives: 1. To evaluate postoperative pain in patients receiving intraligamentary injections of either dexamethasone (4mg/ml), diclofenac sodium (25mg/ml), 0.5% bupivacaine or 2% lidocaine. 2. To compare the postoperative pain in different groups.
Read the detailed description
The patients will receive a primary Inferior alveolar nerve block injection using 1.8 mL of 2% lidocaine with 1: 80 000 epinephrine using a direct Halsted approach. The needle will be inserted until bony resistance is felt. After reaching the target area, aspiration will be performed, and the solution will be deposited over 60 seconds. After 10 minutes, the patients will be asked about the lip numbness. Patients without profound lip numbness will be excluded from the study since the block will be considered as 'missed'. A conventional access opening will be initiated after isolation with a rubber dam. After endodontic instrumentation and placement of temporary restoration, the patients shall receive intraligamentary injections of dexamethasone (4mg/ml), diclofenac sodium (25mg/ml), 0.5% bupivacaine, and 2% lidocaine. The patients will be randomly allocated to treatment groups with the help of an online random generator. The presence of postoperative pain (using Heft Parker visual analog pain scale) will be assessed at 2 hours, 6 hours, 24 hours, and 72 hours after treatment. The pain score proforma shall be collected at the subsequent visit.
- Conditions
- Pulpitis
- Being tested
- Dexamethasone
- Medical subject headings
- Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called diclofenac sodium, bupivacaine
After endodontic instrumentation and placement of temporary restoration, the patients shall receive intraligamentary injections.
| Study group | Role | What they receive |
|---|---|---|
| Intraligamentary injection of dexamethasone | Experimental | After endodontic instrumentation and placement of temporary restoration, the patients shall receive Intraligamentary injection of dexamethasone Receives: Drug: Dexamethasone |
| Intraligamentary injection of diclofenac sodium | Experimental | After endodontic instrumentation and placement of temporary restoration, the patients shall receive Intraligamentary injection of dexamethasone Receives: Drug: Dexamethasone |
| Intraligamentary injection of 0.5% bupivacaine | Experimental | After endodontic instrumentation and placement of temporary restoration, the patients shall receive Intraligamentary injection of dexamethasone Receives: Drug: Dexamethasone |
| Intraligamentary injection of 2% lidocaine | Active comparator | After endodontic instrumentation and placement of temporary restoration, the patients shall receive Intraligamentary injection of dexamethasone Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain
The presence of postoperative pain (using Heft Parker visual analog pain scale) will be assessed at 2 hours, 6 hours, 24 hours and 72 hours after treatment.
Measured: 2 hours, 6 hours, 24 hours and 72 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start2 Dec 2023
- Primary completion3 Mar 2024 (estimated)
- Study completion3 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PulpitisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jamia Millia Islamia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Vivek Aggarwal, Jamia Millia Islamia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186921
- Sponsor's protocol ID
- Postendo pain Intraligamentary
- Status last verified
- Dec 2023
- First submitted
- 17 Dec 2023
- Last updated
- 2 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Intraligamentary Injections on the Post-endodontic Pain in Patients With Symptomatic Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT06186921
- Acronym / sponsor ID
- Postendo pain Intraligamentary
- Conditions
- Pulpitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Jamia Millia IslamiaUniversity, hospital or other
- Study start
- 2 Dec 2023 (actual)
- Primary completion
- 3 Mar 2024 (estimated)
- Study completion
- 3 Mar 2024 (estimated)
- First posted
- 2 Jan 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 will aim to evaluate postoperative pain after intraligamentary injections of dexamethasone (4mg/ml), diclofenac sodium (25mg/ml), 0.5% bupivacaine and 2% lidocaine given to the patients with symptomatic irreversible pulpitis after completion of the first appointment. Objectives: 1. To evaluate postoperative pain in patients receiving intraligamentary injections of either dexamethasone (4mg/ml), diclofenac sodium (25mg/ml), 0.5% bupivacaine or 2% lidocaine. 2. To compare the postoperative pain in different groups.
Detailed description
The patients will receive a primary Inferior alveolar nerve block injection using 1.8 mL of 2% lidocaine with 1: 80 000 epinephrine using a direct Halsted approach. The needle will be inserted until bony resistance is felt. After reaching the target area, aspiration will be performed, and the solution will be deposited over 60 seconds. After 10 minutes, the patients will be asked about the lip numbness. Patients without profound lip numbness will be excluded from the study since the block will be considered as 'missed'. A conventional access opening will be initiated after isolation with a rubber dam. After endodontic instrumentation and placement of temporary restoration, the patients shall receive intraligamentary injections of dexamethasone (4mg/ml), diclofenac sodium (25mg/ml), 0.5% bupivacaine, and 2% lidocaine. The patients will be randomly allocated to treatment groups with the help of an online random generator. The presence of postoperative pain (using Heft Parker visual analog pain scale) will be assessed at 2 hours, 6 hours, 24 hours, and 72 hours after treatment. The pain score proforma shall be collected at the subsequent visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intraligamentary injection of dexamethasone | Experimental | Drug: DexamethasoneAfter endodontic instrumentation and placement of temporary restoration, the patients shall receive Intraligamentary injection of dexamethasone |
| Intraligamentary injection of diclofenac sodium | Experimental | Drug: DexamethasoneAfter endodontic instrumentation and placement of temporary restoration, the patients shall receive Intraligamentary injection of dexamethasone |
| Intraligamentary injection of 0.5% bupivacaine | Experimental | Drug: DexamethasoneAfter endodontic instrumentation and placement of temporary restoration, the patients shall receive Intraligamentary injection of dexamethasone |
| Intraligamentary injection of 2% lidocaine | Active comparator | Drug: DexamethasoneAfter endodontic instrumentation and placement of temporary restoration, the patients shall receive Intraligamentary injection of dexamethasone |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Symptomatic carious exposed mandibular first or second molars.
- Positive and prolonged response to thermal sensitivity tests and electric pulp tests.
- Vital coronal pulp on access cavity preparation.
- American Society of Anesthesiologists class I or II medical history.
- Ability to understand the use of pain scales.
Key exclusion criteria (10 listed)
- Active pain in more than 1 tooth
- Teeth with fused roots.
- Radiographic evidence of an extra root.
- Large restorations with overhanging margins.
- Full crowns or deep periodontal pockets.
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 |
|---|---|---|
| DexamethasoneAlso: diclofenac sodium, bupivacaineAfter endodontic instrumentation and placement of temporary restoration, the patients shall receive intraligamentary injections. | Drug | Intraligamentary injection of 0.5% bupivacaine, Intraligamentary injection of 2% lidocaine, Intraligamentary injection of dexamethasone, Intraligamentary injection of diclofenac sodium |
Primary outcome
Post operative pain
Time frame: 2 hours, 6 hours, 24 hours and 72 hours after treatment
The presence of postoperative pain (using Heft Parker visual analog pain scale) will be assessed at 2 hours, 6 hours, 24 hours and 72 hours after treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone in people with Pulpitis, run by Jamia Millia Islamia at 1 site in India.
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 10 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 2 Jan 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative pain (time frame: 2 hours, 6 hours, 24 hours and 72 hours after 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 2 Jan 2024.