Irreversible PulpitisNCT07233564
Comparison of Pain Between Supraperiosteal Injection of Dexamethasone Versus Placebo on Postoperative Pain in Teeth With Symptomatic Irreversible Pulpitis
A study testing Dexamathsone 4mg/ml associated with experimental arm and Normal saline injection in people with Irreversible Pulpitis, run by College of Physicians and Surgeons Pakistan at 1 site in Pakistan.
Trial summary
This randomized controlled trial aims to compare the effectiveness of supra periosteal injection of dexamethasone versus placebo in reducing post operative pain in teeth diagnosed with symptomatic irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- Dexamathsone 4mg/ml associated with experimental arm and Normal saline injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jul 2025to 15 Feb 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age 18 or above 18 year old (to have complete apex formation)
- Patient with normal periapical area (no pain on percussion).
- Patient who have not received any preoperative analgesic and antibiotic in last one month.
Who cannot join
- Pregnancy and Lactation because radiographs are contraindicated.
- Moderate to severe periodontal disease because teeth are not salvageable.
- Patient with nonvital teeth diagnose via cold test and EPT.
- Patient with known sensitivity to dexamethasone by history.
- Patients whose medical history include a history of certain illnesses, such as HIV, heart disease, or epilepsy (conditions that can affect a patient's rate of healing).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Pain Between Supraperiosteal Injection of Dexamethasone Versus Placebo on Postoperative Pain in Teeth With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
This randomized controlled trial aims to compare the effectiveness of supra periosteal injection of dexamethasone versus placebo in reducing post operative pain in teeth diagnosed with symptomatic irreversible pulpitis. A total of 44 patients will be randomly assigned into two groups: Group A will receive a supra periosteal injection of dexamethasone(4mg/ml), and Group B will receive a similar injection of normal saline as placebo. post operative pain will be assessed at 6hr,24hr and 48hr using a VAS Analogue Scale, with the final outcome measured at 24hrs. the study will help determine whether local dexamethasone injection is effective in minimizing postoperative pain
- Conditions
- Irreversible Pulpitis
- Being tested
- Dexamathsone 4mg/ml associated with experimental arm, Normal saline injection
- Keywords
- Effect of dexamthasone on irreversible pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamathsone 4mg/ml associated with experimental armDrug
particappant in this group will receive a supraperiosteal injection of dexamethasone 4mg/ml at the mucbuccal fold before endodontic treatment of teeth with symptomatic irreversible pulpitis
Normal saline injectionDrug
particapant in this group will receive a supraperiosteal injection of normal saline at mucobuccal fold in the similar manner and volume as the experoimental drug
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone injection group | Experimental | participant in this arm will receive a supraperiosteal injection of 4mg/ml dexamethasone at the mucobuccal fold prior to endodontic treatment for symptomatic irreversible pulpitis Receives: Drug: Dexamathsone 4mg/ml associated with experimental arm |
| Saline injector(placebo) group | Placebo comparator | Not described Receives: Drug: Normal saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain
Pain will be measured using a 10 - point Visual Analogue Scale where 0=no pain, 1-3=mild pain, 4-6= moderate pain, and 7-10 = severe pain the absence of pain will be considered as effective treatment
Measured: 24hr after endodontic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start15 Jul 2025
- Primary completion1 Feb 2026 (estimated)
- Study completion15 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- College of Physicians and Surgeons Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aqsa Afzal, College of Physicians and Surgeons Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233564
- Sponsor's protocol ID
- 117-ERB/023
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pain Between Supraperiosteal Injection of Dexamethasone Versus Placebo on Postoperative Pain in Teeth With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07233564
- Acronym / sponsor ID
- 117-ERB/023
- Conditions
- Irreversible Pulpitis
- Keywords
- Effect of dexamthasone on irreversible pulpitis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (actual)
- Lead sponsor
- College of Physicians and Surgeons PakistanUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 15 Feb 2026 (estimated)
- First posted
- 18 Nov 2025 (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 randomized controlled trial aims to compare the effectiveness of supra periosteal injection of dexamethasone versus placebo in reducing post operative pain in teeth diagnosed with symptomatic irreversible pulpitis. A total of 44 patients will be randomly assigned into two groups: Group A will receive a supra periosteal injection of dexamethasone(4mg/ml), and Group B will receive a similar injection of normal saline as placebo. post operative pain will be assessed at 6hr,24hr and 48hr using a VAS Analogue Scale, with the final outcome measured at 24hrs. the study will help determine whether local dexamethasone injection is effective in minimizing postoperative pain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone injection group | Experimental | Drug: Dexamathsone 4mg/ml associated with experimental armparticipant in this arm will receive a supraperiosteal injection of 4mg/ml dexamethasone at the mucobuccal fold prior to endodontic treatment for symptomatic irreversible pulpitis |
| Saline injector(placebo) group | Placebo comparator | Drug: Normal saline injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients age 18 or above 18 year old (to have complete apex formation)
- Patient with normal periapical area (no pain on percussion).
- Patient who have not received any preoperative analgesic and antibiotic in last one month.
Key exclusion criteria (5 listed)
- Pregnancy and Lactation because radiographs are contraindicated.
- Moderate to severe periodontal disease because teeth are not salvageable.
- Patient with nonvital teeth diagnose via cold test and EPT.
- Patient with known sensitivity to dexamethasone by history.
- Patients whose medical history include a history of certain illnesses, such as HIV, heart disease, or epilepsy (conditions that can affect a patient's rate of healing).
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 |
|---|---|---|
| Dexamathsone 4mg/ml associated with experimental armparticappant in this group will receive a supraperiosteal injection of dexamethasone 4mg/ml at the mucbuccal fold before endodontic treatment of teeth with symptomatic irreversible pulpitis | Drug | Dexamethasone injection group |
| Normal saline injectionparticapant in this group will receive a supraperiosteal injection of normal saline at mucobuccal fold in the similar manner and volume as the experoimental drug | Drug | Saline injector(placebo) group |
Primary outcome
Post operative pain
Time frame: 24hr after endodontic treatment
Pain will be measured using a 10 - point Visual Analogue Scale where 0=no pain, 1-3=mild pain, 4-6= moderate pain, and 7-10 = severe pain the absence of pain will be considered as effective 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 18 Nov 2025.
- Related InfoLink provided by the sponsor.
- 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 study testing Dexamathsone 4mg/ml associated with experimental arm and Normal saline injection in people with Irreversible Pulpitis, run by College of Physicians and Surgeons Pakistan at 1 site in Pakistan.
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 3 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 18 Nov 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 Pakistan. 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. 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.
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?
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?
Post operative pain (time frame: 24hr after endodontic 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 18 Nov 2025.