Post-endodontic PainPhase 2NCT06980870
Effect of Pre-medication With Anti-inflammatory Drugs(Ibuprofen and Dexamethasone)on Post-Endodontic Pain
A Phase 2 study testing Anti-inflammatory drug (ibuprofen) and Anti-inflammatory drug (dexamethsaone) in people with Post-endodontic Pain and Ibuprofen, run by Armed Forces Institute of Dentistry, Pakistan at 1 site in Pakistan.
Trial summary
Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain with symptomatic irreversible pulpitis Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-endodontic Pain, Ibuprofen, Dexamethasone
- What is being tested?
- Anti-inflammatory drug (ibuprofen) and Anti-inflammatory drug (dexamethsaone)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Feb 2025to 15 Jun 2025
- Phase
- Phase 2
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Permanent teeth with acutely inflamed pulp without swelling or draining sinus.
- Patients of either gender aged between 18-50 years old.
- Systemically healthy patients.
- Patients who agree to attend for recall appointments and provide a written consent.
Who cannot join
- Patients on preoperative analgesics and antibiotics.
- Teeth with calcified canals and previously treated teeth.
- Pregnant and lactating mothers.
- Patients who are immunocompromised, anxious and mentally handicapped.
- Patients who are allergic to any of the test medications.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Armed Forces Institute Of Dentistry
Rawalpindi, 46000
Quratulain Abbasi, BDS, 00923315317467, quratulain.abbasi@gmail.com
Maha Ali Mirza, BDS, 009923365605412, mahaalimirza5@gmail.com
About this study
Official title: Effect of Pre-medication With Anti-inflammatory Drugs(Ibuprofen and Dexamethasone)on Post-Endodontic Pain With Symptomatic Irreversible Pulpitis
Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain with symptomatic irreversible pulpitis
Read the detailed description
Study will be conducted after the approval of Institutional Ethics Review Committee, AFID (ANX "A").
A total of 130 entitled patients reporting to Operative Dentistry Department, Armed Forces Institute of Dentistry will be invited for participation in this study. The procedure will be explained to the patients and their parents in Urdu language and a written informed consent will be taken (ANX "B") They will be screened for inclusion by taking history, performing relevant clinical examination and necessary tests along with peri-apical radiographs. Patients fulfilling the inclusion criteria will be divided into two groups using consecutive non random sampling.
Group 1: Patients treated with premedication of Non steroidal anti inflammatory drug (Ibuprofen) Group 2: Patients treated with premedication of Steroidal anti inflammatory drug (Dexamethsone)
Both groups will receive medication 15 mins before intiating root canal treatment. Root canal treatment will then be initiated under local anesthesia and rubber dam isolation. Working length will be taken 1mm from radiographic apex with apex locator and will be confirmed with radiograph. The root canals will be instrumented with ProTaper Next system under copious irrigation with 5.25% sodium hypochlorite (NaOCl). Patency will be confirmed with a #10 K file between each instrument change. The root canals will be flushed with 5 mL of 17% EDTA solution. To control the microbiological impact on post-operative pain calcium hydroxide will be used as an intra-canal medicament and likewise 5.25% sodium hypochlorite as an irrigant in both groups. Following instrumentation and calcium hydroxide placement in the canal using lentulo spirals, the cavity will be temporarily sealed with cavit.
At the end of every appointment, patient will be given a visual analogue scale. The patient will be advised to mark the line corresponding with the intensity of his pain at 24, 48 and 72 hours after the first visit. The patient will be recalled after one week for obturation and final full coverage restoration. Analgesics will be prescribed in case of severe intolerable pain.
- Conditions
- Post-endodontic Pain, Ibuprofen, Dexamethasone
- Being tested
- Anti-inflammatory drug (ibuprofen), Anti-inflammatory drug (dexamethsaone)
- Keywords
- post-endodontic pain, ibuprofen, dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-inflammatory drug (ibuprofen)Drug
Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain
Anti-inflammatory drug (dexamethsaone)Drug
Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain
| Study group | Role | What they receive |
|---|---|---|
| Pain with ibuprofen | Active comparator | Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain Receives: Drug: Anti-inflammatory drug (ibuprofen) |
| Pain with dexamethasone | Active comparator | Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain Receives: Drug: Anti-inflammatory drug (dexamethsaone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of pre-medication(ibuprofen and dexamethasone ) on post-endodontic pain
Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain on visual analogue scale
Measured: 24 hours
effect of pre-medication(ibuprofen and dexamethasone ) on post-endodontic pain
Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain on visual analogue scale
Measured: 48 hours
effect of pre-medication(ibuprofen and dexamethasone ) on post-endodontic pain
Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain on visual analogue scale
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start15 Feb 2025
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-endodontic PainStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Armed Forces Institute of Dentistry, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qurat-ul-ain Abbasi, Armed Forces Institute of Dentistry, Pakistan
- Investigators
- Quratulain Abbasi, BDS, Principal investigator, AFID
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980870
- Sponsor's protocol ID
- Ibuprofen versus Dexamethasone
- Status last verified
- Feb 2025
- First submitted
- 15 Feb 2025
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pre-medication With Anti-inflammatory Drugs(Ibuprofen and Dexamethasone)on Post-Endodontic Pain With Symptomatic Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT06980870
- Acronym / sponsor ID
- Ibuprofen versus Dexamethasone
- Conditions
- Post-endodontic Pain, Ibuprofen, Dexamethasone
- Keywords
- post-endodontic pain, ibuprofen, dexamethasone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Armed Forces Institute of Dentistry, PakistanUniversity, hospital or other
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 20 May 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.
Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain with symptomatic irreversible pulpitis
Detailed description
Study will be conducted after the approval of Institutional Ethics Review Committee, AFID (ANX "A").
A total of 130 entitled patients reporting to Operative Dentistry Department, Armed Forces Institute of Dentistry will be invited for participation in this study. The procedure will be explained to the patients and their parents in Urdu language and a written informed consent will be taken (ANX "B") They will be screened for inclusion by taking history, performing relevant clinical examination and necessary tests along with peri-apical radiographs. Patients fulfilling the inclusion criteria will be divided into two groups using consecutive non random sampling.
Group 1: Patients treated with premedication of Non steroidal anti inflammatory drug (Ibuprofen) Group 2: Patients treated with premedication of Steroidal anti inflammatory drug (Dexamethsone)
Both groups will receive medication 15 mins before intiating root canal treatment. Root canal treatment will then be initiated under local anesthesia and rubber dam isolation. Working length will be taken 1mm from radiographic apex with apex locator and will be confirmed with radiograph. The root canals will be instrumented with ProTaper Next system under copious irrigation with 5.25% sodium hypochlorite (NaOCl). Patency will be confirmed with a #10 K file between each instrument change. The root canals will be flushed with 5 mL of 17% EDTA solution. To control the microbiological impact on post-operative pain calcium hydroxide will be used as an intra-canal medicament and likewise 5.25% sodium hypochlorite as an irrigant in both groups. Following instrumentation and calcium hydroxide placement in the canal using lentulo spirals, the cavity will be temporarily sealed with cavit.
At the end of every appointment, patient will be given a visual analogue scale. The patient will be advised to mark the line corresponding with the intensity of his pain at 24, 48 and 72 hours after the first visit. The patient will be recalled after one week for obturation and final full coverage restoration. Analgesics will be prescribed in case of severe intolerable pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain with ibuprofen | Active comparator | Drug: Anti-inflammatory drug (ibuprofen)Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain |
| Pain with dexamethasone | Active comparator | Drug: Anti-inflammatory drug (dexamethsaone)Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Permanent teeth with acutely inflamed pulp without swelling or draining sinus.
- Patients of either gender aged between 18-50 years old.
- Systemically healthy patients.
- Patients who agree to attend for recall appointments and provide a written consent.
Key exclusion criteria (5 listed)
- Patients on preoperative analgesics and antibiotics.
- Teeth with calcified canals and previously treated teeth.
- Pregnant and lactating mothers.
- Patients who are immunocompromised, anxious and mentally handicapped.
- Patients who are allergic to any of the test medications.
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 |
|---|---|---|
| Anti-inflammatory drug (ibuprofen)Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain | Drug | Pain with ibuprofen |
| Anti-inflammatory drug (dexamethsaone)Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain | Drug | Pain with dexamethasone |
Primary outcome
effect of pre-medication(ibuprofen and dexamethasone ) on post-endodontic pain
Time frame: 24 hours
Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain on visual analogue scale
effect of pre-medication(ibuprofen and dexamethasone ) on post-endodontic pain
Time frame: 48 hours
Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain on visual analogue scale
effect of pre-medication(ibuprofen and dexamethasone ) on post-endodontic pain
Time frame: 72 hours
Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain on visual analogue scale
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 20 May 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Post-endodontic Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Not yet recruiting
Effect of Intracanal Cryotherapy on Pain, Anxiety, and Salivary Irisin After Root Canal Treatment
Postoperative Pain After Endodontic Treatment, Dental Anxiety
Recruiting
Cryotherapy, PGE2, NGF Levels and Pain After Endodontic Retreatment
Asymptomatic Apical Periodontitis, Endodontic Retreatment
Recruiting
Effect of Different Apical Motion Algorithms on Postoperative Pain After Root Canal Treatment
Apical Periodontitis, Postoperative Pain After Endodontic Treatment
Not yet recruiting
Photobiomodulation After Nonsurgical Root Canal Treatment
Symptomatic Apical Periodontitis, Postoperative Pain
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.
Quratulain Abbasi, BDS principal investigator
AFID
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anti-inflammatory drug (ibuprofen) and Anti-inflammatory drug (dexamethsaone) in people with Post-endodontic Pain and Ibuprofen, run by Armed Forces Institute of Dentistry, 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 4 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: looking for participants now, as of the sponsor's last update on 20 May 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Quratulain Abbasi, BDS (00923315317467, quratulain.abbasi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect of pre-medication(ibuprofen and dexamethasone ) on post-endodontic pain (time frame: 24 hours). The study lists 3 primary outcomes in all. 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 20 May 2025.