Symptomatic Irreversible PulpitisPhase 4DILASNCT07699315
Preoperative Dexamethasone Injection to Improve Local Anesthesia Success in Endodontic Treatment
A Phase 4 study testing dexamethasone and Saline (0.9% NaCl) in people with Symptomatic Irreversible Pulpitis, run by Watim Medical & Dental College.
Trial summary
This study aims to determine whether giving a single dose of 4mg dexamethasone before root canal treatment can reduce the amount of pain patients experience during the procedure . Patients diagnosed with symptomatic Irreversible Pulpitis requiring endodontic treatment will be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Symptomatic Irreversible Pulpitis
- What is being tested?
- dexamethasone and Saline (0.9% NaCl)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with pain VAS >/= 6
- Carious exposed mandibular molar with symptomatic irreversible pulpitis
- Patients between ages 18-60 years
- American Society of Anesthesiologists class I or II medical histories -
Who cannot join
- 1. Patients with contraindications to local anesthesia solution or dexamethasone 2.Pregnant or breast-feeding females 4.Tooth having fused/extra roots, full coverage crowns, or poor periodontal status 5. Patients taking drugs which could affect the pain perception
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Preoperative Intraligamentary Injection of Dexamethasone Can Improve the Anesthetic Success Rate of 2% Lidocaine During the Endodontic Management of Mandibular Molars With Symptomatic Irreversible Pulpitis
This study aims to determine whether giving a single dose of 4mg dexamethasone before root canal treatment can reduce the amount of pain patients experience during the procedure . Patients diagnosed with symptomatic Irreversible Pulpitis requiring endodontic treatment will be enrolled. Participants will receive either dexamethasone or placebo before treatment , and pain during the procedure will be measured using a Visual Analogue Scale (VAS) .
The findings may help improve pain management strategies during root canal treatment .
Read the detailed description
Symptomatic irreversible pulpitis is a common cause of severe dental pain, and achieving adequate pain control during endodontic treatment remains a challenge despite the use of local anesthesia. Inflammatory mediators present in inflamed pulp tissues may reduce the effectiveness of local anesthetics , resulting in persistent intraoperative pain.
Dexamethasone is a corticosteroid with potent anti-inflammatory properties that may reduce inflammatory mediator release and improve pain control . This randomized controlled clinical trial aims to evaluate the effectiveness of preoperative 4mg dose of dexamethasone compared with placebo in reducing intraoperative pain during endodontic treatment of teeth diagnosed with symptomatic irreversible pulpitis.
Eligible participants will be randomly allocated to receive either dexamethasone or placebo before treatment . Standard local anesthesia and endodontic procedures will be performed for all participants .
Intraoperative pain intensity will be assessed using a Visual Analogue Scale. The primary outcome will be the difference in intraoperative pain scores between the two groups.
The results of this study may provide evidence regarding the role of preoperative dexamethasone as an adjunct for improving pain control during endodontic treatment .
- Conditions
- Symptomatic Irreversible Pulpitis
- Being tested
- dexamethasone, Saline (0.9% NaCl)
- Keywords
- Symptomatic Irreversible Pulpitis, Dexamethasone, Root canal Treatment, Intraoperative pain, Endodontics, local anesthesia, Inferior Alveolar Nerve Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasoneDrug
participants receive 4mg dexamethasone administered via intraligamental infiltration followed by inferior alveolar nerve block before endodontic treatment of mandibular molars with symptomatic irreversible pulpitis
Saline (0.9% NaCl)Drug
participants receive an equivalent volume of normal saline administered via intraligamental infiltration before root canal treatment for symptomatic irreversible pulpitis
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone Group | Experimental | Participants receive dexamethasone as an adjunct to local anesthesia before endodontic treatment for symptomatic irreversible pulpitis Receives: Drug: dexamethasone |
| Saline | Placebo comparator | participants receive normal saline as a placeb adjunct to local anesthesia before endodontic treatment for symptomatic irreversible pulpitis Receives: Drug: Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative pain intensity
intraoperative pain intensity measured using the Heft-parker Visual Analogue Scale following root canal treatment
Measured: Pain intensity assessed intraoperatively from initiation of access cavity preparation until completion of canal instrumentation during a single visit ( approximately 30-90 minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Irreversible 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective ,randomized, placebo controlled , parallel-group clinical trial evaluating the effect of preoperative intraligamentary dexamethasone injection on the anesthetic success of 2% lidocaine during endodontic treatment of mandibular molars with symptomatic irreversible pulpitis . Sixty participants will be randomly allocated to receive either dexamethasone (4mg/ml) or sterile normal saline before inferior alveolar nerve block. The primary outcome is anesthetic success , defined as pain-free endodontic treatment without the need for supplemental anesthesia.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Watim Medical & Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayesha Sarwar, Watim Medical & Dental College
- Investigators
- Dr.Ayesha S Janjua, BDS, Principal investigator, Watim Medical and Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699315
- Sponsor's protocol ID
- WMDC/R&D(ERB)/2024/157
- Acronym
- DILAS
- Status last verified
- Aug 2026
- First submitted
- 3 Jul 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Intraligamentary Injection of Dexamethasone Can Improve the Anesthetic Success Rate of 2% Lidocaine During the Endodontic Management of Mandibular Molars With Symptomatic Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT07699315
- Acronym / sponsor ID
- DILAS / WMDC/R&D(ERB)/2024/157
- Conditions
- Symptomatic Irreversible Pulpitis
- Keywords
- Symptomatic Irreversible Pulpitis, Dexamethasone, Root canal Treatment, Intraoperative pain, Endodontics, local anesthesia, Inferior Alveolar Nerve Block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Watim Medical & Dental CollegeUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Jul 2026 (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 determine whether giving a single dose of 4mg dexamethasone before root canal treatment can reduce the amount of pain patients experience during the procedure . Patients diagnosed with symptomatic Irreversible Pulpitis requiring endodontic treatment will be enrolled. Participants will receive either dexamethasone or placebo before treatment , and pain during the procedure will be measured using a Visual Analogue Scale (VAS) .
The findings may help improve pain management strategies during root canal treatment .
Detailed description
Symptomatic irreversible pulpitis is a common cause of severe dental pain, and achieving adequate pain control during endodontic treatment remains a challenge despite the use of local anesthesia. Inflammatory mediators present in inflamed pulp tissues may reduce the effectiveness of local anesthetics , resulting in persistent intraoperative pain.
Dexamethasone is a corticosteroid with potent anti-inflammatory properties that may reduce inflammatory mediator release and improve pain control . This randomized controlled clinical trial aims to evaluate the effectiveness of preoperative 4mg dose of dexamethasone compared with placebo in reducing intraoperative pain during endodontic treatment of teeth diagnosed with symptomatic irreversible pulpitis.
Eligible participants will be randomly allocated to receive either dexamethasone or placebo before treatment . Standard local anesthesia and endodontic procedures will be performed for all participants .
Intraoperative pain intensity will be assessed using a Visual Analogue Scale. The primary outcome will be the difference in intraoperative pain scores between the two groups.
The results of this study may provide evidence regarding the role of preoperative dexamethasone as an adjunct for improving pain control during endodontic treatment .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a prospective ,randomized, placebo controlled , parallel-group clinical trial evaluating the effect of preoperative intraligamentary dexamethasone injection on the anesthetic success of 2% lidocaine during endodontic treatment of mandibular molars with symptomatic irreversible pulpitis . Sixty participants will be randomly allocated to receive either dexamethasone (4mg/ml) or sterile normal saline before inferior alveolar nerve block. The primary outcome is anesthetic success , defined as pain-free endodontic treatment without the need for supplemental anesthesia.
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone Group | Experimental | Drug: dexamethasoneParticipants receive dexamethasone as an adjunct to local anesthesia before endodontic treatment for symptomatic irreversible pulpitis |
| Saline | Placebo comparator | Drug: Saline (0.9% NaCl)participants receive normal saline as a placeb adjunct to local anesthesia before endodontic treatment for symptomatic irreversible pulpitis |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with pain VAS >/= 6
- Carious exposed mandibular molar with symptomatic irreversible pulpitis
- Patients between ages 18-60 years
- American Society of Anesthesiologists class I or II medical histories -
Key exclusion criteria (2 listed)
- 1. Patients with contraindications to local anesthesia solution or dexamethasone 2.Pregnant or breast-feeding females 4.Tooth having fused/extra roots, full coverage crowns, or poor periodontal status 5. Patients taking drugs which could affect the pain perception
- -
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 |
|---|---|---|
| dexamethasoneparticipants receive 4mg dexamethasone administered via intraligamental infiltration followed by inferior alveolar nerve block before endodontic treatment of mandibular molars with symptomatic irreversible pulpitis | Drug | Dexamethasone Group |
| Saline (0.9% NaCl)participants receive an equivalent volume of normal saline administered via intraligamental infiltration before root canal treatment for symptomatic irreversible pulpitis | Drug | Saline |
Primary outcome
Intraoperative pain intensity
Time frame: Pain intensity assessed intraoperatively from initiation of access cavity preparation until completion of canal instrumentation during a single visit ( approximately 30-90 minutes).
intraoperative pain intensity measured using the Heft-parker Visual Analogue Scale following root canal treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Symptomatic Irreversible Pulpitis
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Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
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Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
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Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial
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Cost-Effectiveness of Upfront Supplemental Anaesthesia in Symptomatic Irreversible Pulpitis
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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.
Dr.Ayesha S Janjua, BDS principal investigator
Watim Medical and Dental College
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dexamethasone and Saline (0.9% NaCl) in people with Symptomatic Irreversible Pulpitis, run by Watim Medical & Dental College.
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 2 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: opening soon, as of the sponsor's last update on 24 Aug 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayesha S Janjua, BDS (+92 321 5252096, ashsarwar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative pain intensity (time frame: Pain intensity assessed intraoperatively from initiation of access cavity preparation until completion of canal instrumentation during a single visit ( approximately 30-90 minutes).). 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 24 Aug 2026.