Post Operative Pain, AcutePhase 4Dex/postopNCT07755306
Postoperative Pain After Dexamethasone Injection by Two Techniques in Irreversible Pulpitis
A Phase 4 study testing dexamethasone 8mg in people with Post Operative Pain, Acute, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this randomized clinical trial to evaluate the effect of dexamethasone in two different techniques on postoperative pain by dividing patients randomly into three groups: Group I: buccinator injection of dexamethasone. Group II: buccal infiltration of dexamethasone. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain, Acute
- What is being tested?
- dexamethasone 8mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Mar 2024to 26 Apr 2026
- Phase
- Phase 4
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both genders
- Older than age of (18 to 60) years
- Participants willing to commit for the entire period of the trial and agreed to sign the written consent after full explanation of the study
- Having a mandibular molar tooth with vital pulp
- These patients were also suffering from symptomatic irreversible pulpitis ,intermittent or continuous sharp pain that lasts longer after removal of the stimulus
- Patients with moderate to severe symptoms VAS≥4
Who cannot join
- Vulnerable group; pregnant females, mentally ill and diseased patientsetc.…
- Patients irritable to local anesthesia
- Patients who are supposed to take plain anesthesia
- Use of analgesic or antibiotic within 6 hours before the visit
- Absence of bleeding in the pulp chamber during cavity preparation
- Severe periodontal disease b- Patients' randomization, allocation and blinding:
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Pain in Patients With Symptomatic Irreversible Pulpitis After Using Dexamethasone in Combination With Local Anesthesia by Two Different Techniques (Randomized Clinical Trial)
The aim of this randomized clinical trial to evaluate the effect of dexamethasone in two different techniques on postoperative pain by dividing patients randomly into three groups:
- Group I: buccinator injection of dexamethasone.
- Group II: buccal infiltration of dexamethasone.
- Group III (Control): IANB using local anesthesia only post operative pain will be evaluated subjectively by patients by VAS score after procedure immediately and follow up for 12, 24 and 72 hours and frequency of analgesic intake
Read the detailed description
the previous studies used dexamethasone with LA to prolong the duration of nerve block , Dexamethasone is used in reducing intraoperative endodontic pain the study main aim is to overcome the problem of severe postoperative pain after endodontic treatment in patients with acute irreversible pulpitis by evaluating the effect of dexamethasone in two different techniques by giving dexamethasone injection of buccinator muscle, or dexamethasone as buccal infiltration, and comparing the results with inferior alveolar nerve block using local anesthesia only. pain score evaluated using VAS score preoperatively and postoperatively with different anesthetic techniques after endodontic treatment.and their effet on frequency of analgesic intake
- Conditions
- Post Operative Pain, Acute
- Being tested
- dexamethasone 8mg
- Keywords
- irreversible pulpitis, postoperative pain, visual analogue score, dexamethasone, buccinator injection, buccal infiltration
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasone 8mgDrug
8mg/2ml injected slowly 30 sec for 1ml as single injection before the endo treatment
| Study group | Role | What they receive |
|---|---|---|
| buccinator injected by DEX drug | Active comparator | patients will receive dexamethasone(2ml/8mg) 1ml per 30 sec slow injection at buccinator muscle as single injection preoperatively Receives: Drug: dexamethasone 8mg |
| buccal infiltration by DEX drug | Active comparator | buccal infiltration of dexamethasone (8mg/2ml) as single injection preoperative Receives: Drug: dexamethasone 8mg |
| control | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue score (VAS) from 0 to 10
VAS preoperative ,immediately postoperative,12hrs,24hrs,72hrs
Measured: postoperative 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start26 Mar 2024
- Primary completion26 Dec 2025
- Study completion26 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Pain, AcuteStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- • patients will be randomly divided into three groups: * Group I: will receive buccinator muscle injection of dexamethasone((2ml of 8mg) after inferior alveolar nerve block (IANB) * Group II: will receive buccal infiltration of dexamethasone (2ml of 8mg) after (IANB) * Group III (Control): will receive IANB by anesthetic 4% articaine HCl with 1:100,000 ratio of epinephrine only.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Medhat, Ain Shams University
- Investigators
- Abeer Abdelhakim Elgendy, Professor, Principal investigator, Faculty of Dentistry, Ain Shams UniversityMahmoud Fahim, lecturer, Study director, Faculty of Dentistry, Ain Shams Universitysalma masoud, master student, Study chair, Faculty of Dentistry, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755306
- Sponsor's protocol ID
- FDASU-Rec IM122413
- Other IDs
- self funded
- Acronym
- Dex/postop
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data will be available upon request for selected people
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain in Patients With Symptomatic Irreversible Pulpitis After Using Dexamethasone in Combination With Local Anesthesia by Two Different Techniques (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT07755306
- Acronym / sponsor ID
- Dex/postop / FDASU-Rec IM122413
- Conditions
- Post Operative Pain, Acute
- Keywords
- irreversible pulpitis, postoperative pain, visual analogue score, dexamethasone, buccinator injection, buccal infiltration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 26 Dec 2025 (actual)
- Study completion
- 26 Apr 2026 (actual)
- First posted
- 10 Aug 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.
The aim of this randomized clinical trial to evaluate the effect of dexamethasone in two different techniques on postoperative pain by dividing patients randomly into three groups:
- Group I: buccinator injection of dexamethasone.
- Group II: buccal infiltration of dexamethasone.
- Group III (Control): IANB using local anesthesia only post operative pain will be evaluated subjectively by patients by VAS score after procedure immediately and follow up for 12, 24 and 72 hours and frequency of analgesic intake
Detailed description
the previous studies used dexamethasone with LA to prolong the duration of nerve block , Dexamethasone is used in reducing intraoperative endodontic pain the study main aim is to overcome the problem of severe postoperative pain after endodontic treatment in patients with acute irreversible pulpitis by evaluating the effect of dexamethasone in two different techniques by giving dexamethasone injection of buccinator muscle, or dexamethasone as buccal infiltration, and comparing the results with inferior alveolar nerve block using local anesthesia only. pain score evaluated using VAS score preoperatively and postoperatively with different anesthetic techniques after endodontic treatment.and their effet on frequency of analgesic intake
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- • patients will be randomly divided into three groups: * Group I: will receive buccinator muscle injection of dexamethasone((2ml of 8mg) after inferior alveolar nerve block (IANB) * Group II: will receive buccal infiltration of dexamethasone (2ml of 8mg) after (IANB) * Group III (Control): will receive IANB by anesthetic 4% articaine HCl with 1:100,000 ratio of epinephrine only.
| Arm | Type | Receives |
|---|---|---|
| buccinator injected by DEX drug | Active comparator | Drug: dexamethasone 8mgpatients will receive dexamethasone(2ml/8mg) 1ml per 30 sec slow injection at buccinator muscle as single injection preoperatively |
| buccal infiltration by DEX drug | Active comparator | Drug: dexamethasone 8mgbuccal infiltration of dexamethasone (8mg/2ml) as single injection preoperative |
| control | No intervention | –no intervention |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Both genders
- Older than age of (18 to 60) years
- Participants willing to commit for the entire period of the trial and agreed to sign the written consent after full explanation of the study
- Having a mandibular molar tooth with vital pulp
- These patients were also suffering from symptomatic irreversible pulpitis ,intermittent or continuous sharp pain that lasts longer after removal of the stimulus
Key exclusion criteria (6 listed)
- Vulnerable group; pregnant females, mentally ill and diseased patientsetc.…
- Patients irritable to local anesthesia
- Patients who are supposed to take plain anesthesia
- Use of analgesic or antibiotic within 6 hours before the visit
- Absence of bleeding in the pulp chamber during cavity preparation
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 |
|---|---|---|
| dexamethasone 8mg8mg/2ml injected slowly 30 sec for 1ml as single injection before the endo treatment | Drug | buccal infiltration by DEX drug, buccinator injected by DEX drug |
Primary outcome
visual analogue score (VAS) from 0 to 10
Time frame: postoperative 72 hours
VAS preoperative ,immediately postoperative,12hrs,24hrs,72hrs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No. data will be available upon request for selected people
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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.
Abeer Abdelhakim Elgendy, Professor principal investigator
Faculty of Dentistry, Ain Shams University
Mahmoud Fahim, lecturer study director
Faculty of Dentistry, Ain Shams University
salma masoud, master student study chair
Faculty of Dentistry, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dexamethasone 8mg in people with Post Operative Pain, Acute, run by Ain Shams University at 1 site in Egypt.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 14 Aug 2026. 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 Egypt. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
visual analogue score (VAS) from 0 to 10 (time frame: postoperative 72 hours). 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 14 Aug 2026.