Dexamethasone AdministrationPhase 1NCT06809855
The Effectiveness of Using a Single Post-operative Intramuscular Dexamethasone Injection on Patients with Surgical Extraction of Lower Third Molar
A Phase 1 study testing Dexamethasone in people with Dexamethasone Administration and Post Extraction Complication, run by Yassir R. Al-khannaq at 1 site in Iraq.
Trial summary
Evaluating the effectiveness of using a single immediate postoperative intramuscular Dexamethasone injection on pain, swelling, trismus and tissue healing in the first seven days. Read more about this study
- Who is it for?
- Ages 15 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dexamethasone Administration, Post Extraction Complication
- 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
- 16 participants
- Where
- 1 siteIraq
- Study dates
- 20 Apr 2024to 16 Oct 2024
- Phase
- Phase 1
- 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 15 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- bilateral similar impacted lower third molar
- willing to do surgical extraction
Who cannot join
- Patients who are not fulfill the inclusion criteria
- allergic to dexamethasone
- who has medical diseases
- taking any medications
- pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
Iraq1 site
Department of Oral and Maxillofacial Surgery, College of Dentistry, University of Baghdad
Baghdad
About this study
Official title: The Effectiveness of Using a Single Post-operative Intramuscular Dexamethasone Injection on Patients with Surgical Extraction of Lower Third Molar(Split Mouth Technique)
Evaluating the effectiveness of using a single immediate postoperative intramuscular Dexamethasone injection on pain, swelling, trismus and tissue healing in the first seven days.
Methods: A split mouth technique on 16 patients with bilateral similar impacted mandibular third molar were extracted; one side was given 8mg intramuscular injection of dexamethasone (study group) and the other side wasn't given injection (control group) and compare of the two sides were done in the following seven days.
- Being tested
- Dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
single 8mg post-operative intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| dexamethasone immediate injection postoperatively | Active comparator | intramuscular injection of a single dose 8mg dexamethasone immediate postoperatively after removal of impacted mandibular third molar Receives: Drug: Dexamethasone |
| no intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative pain changes
measurement of change in pain on visual scale analog from 10 to 1 , 10 mean the worst pain and 1 is least pain
Measured: each participant was seen at 1st, 3rd and 7th post-operative days
Change in post operative swelling
The swelling was measured between two points marked on skin in millimeters using ruler
Measured: each participant was seen at 1st, 3rd and 7th post-operative days
Post operative Change in mouth opening
The distance between upper and lower incisors was measured in millimeters using ruler
Measured: each participant was seen at 1st, 3rd and 7th post-operative days
Secondary outcomes (1)
Tissue healing
Healing of extraction site was assessed by using Landry, Turnbull and Howley index
Measured: Healing was assessed on the 7th postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start20 Apr 2024
- Primary completion15 Sep 2024
- Study completion16 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dexamethasone AdministrationStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Each patient resembles the study group in which the patient is injected intramuscularly by a single dose 8mg dexamethasone immediate postoperatively after removal of impacted mandibular third molar on one side and control group on which the impacted mandibular third molar on the other side is removed without usage of 8mg dexamethasone.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yassir R. Al-khannaq
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yassir R. Al-khannaq, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06809855
- Sponsor's protocol ID
- 997124
- Status last verified
- Feb 2025
- First submitted
- 30 Jan 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Using a Single Post-operative Intramuscular Dexamethasone Injection on Patients with Surgical Extraction of Lower Third Molar(Split Mouth Technique)
- ClinicalTrials.gov ID
- NCT06809855
- Acronym / sponsor ID
- 997124
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Yassir R. Al-khannaqUniversity, hospital or other
- Study start
- 20 Apr 2024 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 16 Oct 2024 (actual)
- First posted
- 5 Feb 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.
Evaluating the effectiveness of using a single immediate postoperative intramuscular Dexamethasone injection on pain, swelling, trismus and tissue healing in the first seven days.
Methods: A split mouth technique on 16 patients with bilateral similar impacted mandibular third molar were extracted; one side was given 8mg intramuscular injection of dexamethasone (study group) and the other side wasn't given injection (control group) and compare of the two sides were done in the following seven days.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each patient resembles the study group in which the patient is injected intramuscularly by a single dose 8mg dexamethasone immediate postoperatively after removal of impacted mandibular third molar on one side and control group on which the impacted mandibular third molar on the other side is removed without usage of 8mg dexamethasone.
| Arm | Type | Receives |
|---|---|---|
| dexamethasone immediate injection postoperatively | Active comparator | Drug: Dexamethasoneintramuscular injection of a single dose 8mg dexamethasone immediate postoperatively after removal of impacted mandibular third molar |
| no intervention | No intervention | – |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- bilateral similar impacted lower third molar
- willing to do surgical extraction
Key exclusion criteria (5 listed)
- Patients who are not fulfill the inclusion criteria
- allergic to dexamethasone
- who has medical diseases
- taking any medications
- pregnant or lactating women
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 |
|---|---|---|
| Dexamethasonesingle 8mg post-operative intramuscular injection | Drug | dexamethasone immediate injection postoperatively |
Primary outcome
post operative pain changes
Time frame: each participant was seen at 1st, 3rd and 7th post-operative days
measurement of change in pain on visual scale analog from 10 to 1 , 10 mean the worst pain and 1 is least pain
Change in post operative swelling
Time frame: each participant was seen at 1st, 3rd and 7th post-operative days
The swelling was measured between two points marked on skin in millimeters using ruler
Post operative Change in mouth opening
Time frame: each participant was seen at 1st, 3rd and 7th post-operative days
The distance between upper and lower incisors was measured in millimeters using ruler
1 secondary outcome
Tissue healing
Time frame: Healing was assessed on the 7th postoperative day
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 25 Feb 2025.
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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 Phase 1 study testing Dexamethasone in people with Dexamethasone Administration and Post Extraction Complication, run by Yassir R. Al-khannaq at 1 site in Iraq.
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 2 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: finished, as of the sponsor's last update on 25 Feb 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 Iraq. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
post operative pain changes (time frame: each participant was seen at 1st, 3rd and 7th post-operative days). 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 25 Feb 2025; AzTrials last refreshed its copy on 3 Nov 2026.