Postoperative PainPhase 3NCT07413055
Comparative Efficacy Of 4 mg VS. 8 mg Submucosal Dexamethasone In Postoperative Pain Management After Dental Implant Surgery: A Randomized Double-Blind Controlled Clinical Trial
A Phase 3 study testing Dexamethasone 4 Mg/mL Injectable Solution and Dexamethasone 8Mg Solution for Injection in people with Postoperative Pain, run by Oman Ministry of Health at 1 site in Oman.
Trial summary
This study aims to compare the effectiveness of 4mg and 8mg dexamethasone administered submucosally in reducing postoperative pain after dental implant surgery. Participants will be randomly assigned to receive either 4mg dexamethasone, 8mg dexamethasone, or a placebo (normal saline) at the surgical site. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Dexamethasone 4 Mg/mL Injectable Solution and Dexamethasone 8Mg Solution for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 1 siteOman
- Study dates
- 25 Mar 2026to 1 Dec 2026
- Phase
- Phase 3
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males \& females
- Age range (21-80)
- ASA I \& II according to (American Society of Anesthesiologists) classification
- Single tooth implant
- Type 3 \& type 4 implant placement timing (Chen and Buser, 2009)
Who cannot join
- Any known allergy to any medications which will be used in the study
- Smokers/ Alcoholics
- Pregnant and lactating women
- Bone augmentation/ sinus lifting required during the surgery
- The need of antibiotic prophylaxis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Oman1 site, 1 recruiting
- Recruiting
Al Nahdha Hospital
Muscat
Nasser Al Khaldi, Senior Consultant Prostho, +968 92898987, dent2020@gmail.com
About this study
Official title: Comparative Efficacy of 4 mg vs. 8 mg Submucosal Dexamethasone in Postoperative Pain Management After Dental Implant Surgery: A Randomized Double-Blind Controlled Clinical Trial
This study aims to compare the effectiveness of 4mg and 8mg dexamethasone administered submucosally in reducing postoperative pain after dental implant surgery. Participants will be randomly assigned to receive either 4mg dexamethasone, 8mg dexamethasone, or a placebo (normal saline) at the surgical site.
Later, postoperative pain will be assessed using a Visual Analog Scale at 6 hours after the surgery and daily for the next 6 days. Also the number of pain-relief tablets consumed after the surgery will be recorded.
Read more
Preoperative anxiety will be assessed using Generalized Anxiety Disorder-7 (GAD-7) questionnaire to assess its association with postoperative pain scores.
The results of this study will help determine the optimal dose of dexamethasone that is effective for postoperative pain control following dental implant surgery.
- Conditions
- Postoperative Pain
- Being tested
- Dexamethasone 4 Mg/mL Injectable Solution, Dexamethasone 8Mg Solution for Injection, Saline (NaCl 0,9 %) (placebo)
- Keywords
- Dexamethasone, Dental implants, Postoperative pain, Submucosal injection, Analgesic consumption, Anxiety
- Medical subject headings
- Pain, Postoperative, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone 4 Mg/mL Injectable SolutionDrug
Syringe will be concealed. Submucosal injection will be adjacent to the surgical site in the buccal vestibule
Dexamethasone 8Mg Solution for InjectionDrug
Syringe will be concealed. Submucosal injection will be adjacent to the surgical site in the buccal vestibule
Saline (NaCl 0,9 %) (placebo)Drug
Syringe will be concealed. Submucosal injection will be adjacent to the surgical site in the buccal vestibule
| Study group | Role | What they receive |
|---|---|---|
| 8mg Dexamethasone | Experimental | 8mg/2ml dexamethasone injection. Receives: Drug: Dexamethasone 8Mg Solution for Injection |
| 4mg Dexamethasone | Experimental | 4mg/1ml Dexamethasone ampoule + 1ml of sterile normal saline for injection. Mixing dexamethasone with sterile normal saline for injection is considered safe and has no effect on drug potency and efficacy based on current evidence. Receives: Drug: Dexamethasone 4 Mg/mL Injectable Solution |
| Placebo | Placebo comparator | 2 ml of sterile normal saline for injection. Receives: Drug: Saline (NaCl 0,9 %) (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain assessed using Visual Analog Scale (VAS)
Postoperative pain will be assessed using a 10-cm visual analog scale in patients following single dental implant surgery after submucosal administration of dexamethasone or placebo
Measured: at 6 hours postoperatively and then once daily for the following 6 days
Secondary outcomes (2)
Number of postoperative analgesic tablets consumed
The total number of rescue analgesic tablets consumed postoperatively will be recorded daily following the implant surgery
Measured: Postoperatively for 7 days
Correlation between preoperative anxiety (GAD-7) and postoperative pain score
Anxiety will be assessed preoperatively using Generalized Anxiety Disorder-7 questionnaire. The relationship between preoperative anxiety scores and postoperative VAS following dental implant surgery will evaluated.
Measured: Anxiety will be assessed preoperatively on the day of the surgery before implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start25 Mar 2026 (estimated)
- Primary completion15 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oman Ministry of Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shurooq Al-Hinai, Oman Ministry of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413055
- Sponsor's protocol ID
- MoH/CSR/25/29882
- Status last verified
- Mar 2026
- First submitted
- 9 Feb 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of 4 mg vs. 8 mg Submucosal Dexamethasone in Postoperative Pain Management After Dental Implant Surgery: A Randomized Double-Blind Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07413055
- Acronym / sponsor ID
- MoH/CSR/25/29882
- Conditions
- Postoperative Pain
- Keywords
- Dexamethasone, Dental implants, Postoperative pain, Submucosal injection, Analgesic consumption, Anxiety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Oman Ministry of HealthOther government
- Study start
- 25 Mar 2026 (estimated)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 17 Feb 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 compare the effectiveness of 4mg and 8mg dexamethasone administered submucosally in reducing postoperative pain after dental implant surgery. Participants will be randomly assigned to receive either 4mg dexamethasone, 8mg dexamethasone, or a placebo (normal saline) at the surgical site.
Later, postoperative pain will be assessed using a Visual Analog Scale at 6 hours after the surgery and daily for the next 6 days. Also the number of pain-relief tablets consumed after the surgery will be recorded.
Preoperative anxiety will be assessed using Generalized Anxiety Disorder-7 (GAD-7) questionnaire to assess its association with postoperative pain scores.
The results of this study will help determine the optimal dose of dexamethasone that is effective for postoperative pain control following dental implant surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 8mg Dexamethasone | Experimental | Drug: Dexamethasone 8Mg Solution for Injection8mg/2ml dexamethasone injection. |
| 4mg Dexamethasone | Experimental | Drug: Dexamethasone 4 Mg/mL Injectable Solution4mg/1ml Dexamethasone ampoule + 1ml of sterile normal saline for injection. Mixing dexamethasone with sterile normal saline for injection is considered safe and has no effect on drug potency and efficacy based on current evidence. |
| Placebo | Placebo comparator | Drug: Saline (NaCl 0,9 %) (placebo)2 ml of sterile normal saline for injection. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males \& females
- Age range (21-80)
- ASA I \& II according to (American Society of Anesthesiologists) classification
- Single tooth implant
- Type 3 \& type 4 implant placement timing (Chen and Buser, 2009)
Key exclusion criteria (5 listed)
- Any known allergy to any medications which will be used in the study
- Smokers/ Alcoholics
- Pregnant and lactating women
- Bone augmentation/ sinus lifting required during the surgery
- The need of antibiotic prophylaxis
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 4 Mg/mL Injectable SolutionSyringe will be concealed. Submucosal injection will be adjacent to the surgical site in the buccal vestibule | Drug | 4mg Dexamethasone |
| Dexamethasone 8Mg Solution for InjectionSyringe will be concealed. Submucosal injection will be adjacent to the surgical site in the buccal vestibule | Drug | 8mg Dexamethasone |
| Saline (NaCl 0,9 %) (placebo)Syringe will be concealed. Submucosal injection will be adjacent to the surgical site in the buccal vestibule | Drug | Placebo |
Primary outcome
Postoperative pain assessed using Visual Analog Scale (VAS)
Time frame: at 6 hours postoperatively and then once daily for the following 6 days
Postoperative pain will be assessed using a 10-cm visual analog scale in patients following single dental implant surgery after submucosal administration of dexamethasone or placebo
2 secondary outcomes
Number of postoperative analgesic tablets consumed
Time frame: Postoperatively for 7 days
Correlation between preoperative anxiety (GAD-7) and postoperative pain score
Time frame: Anxiety will be assessed preoperatively on the day of the surgery before implant placement
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 30 Mar 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone 4 Mg/mL Injectable Solution and Dexamethasone 8Mg Solution for Injection in people with Postoperative Pain, run by Oman Ministry of Health at 1 site in Oman.
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 5 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 30 Mar 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 Oman. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Shurooq Slim Al Hinai, BDS (+968 96148103, shurooqalhinai@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain assessed using Visual Analog Scale (VAS) (time frame: at 6 hours postoperatively and then once daily for the following 6 days). 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 30 Mar 2026.