ClinicalTrials.gg
RecruitingNCT07413055Updated Mar 30, 2026

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 interventional study of Dexamethasone 4 Mg/mL Injectable Solution and Dexamethasone 8Mg Solution for Injection in Postoperative Pain, sponsored by Oman Ministry of Health. Recruiting at 1 site in Oman. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-30.

Sponsored by Oman Ministry of Health · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
138
Allocation
Randomized
Ages
21 Years to 80 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Postoperative Pain

Keywords

  • Dexamethasone
  • Dental implants
  • Postoperative pain
  • Submucosal injection
  • Analgesic consumption
  • Anxiety
03

In context

Pain, Postoperative

5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.

This study's planned enrollment of 138 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Oman Ministry of Health is the lead sponsor of 18 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Males \& females
  • Age range (21-80)
  • \& II according to (American Society of Anesthesiologists) classification
  • Single tooth implant
  • Type 3 \& type 4 implant placement timing (Chen and Buser, 2009)

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
138 participants (estimated)

Study arms

  • Experimental
    8mg Dexamethasone

    8mg/2ml dexamethasone injection.

    Drug: Dexamethasone 8Mg Solution for Injection

  • Experimental
    4mg Dexamethasone

    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.

    Drug: Dexamethasone 4 Mg/mL Injectable Solution

  • Placebo comparator
    Placebo

    2 ml of sterile normal saline for injection.

    Drug: Saline (NaCl 0,9 %) (placebo)

Interventions

  • DrugDexamethasone 4 Mg/mL Injectable Solution

    Drug page: Dexamethasone

    Syringe will be concealed. Submucosal injection will be adjacent to the surgical site in the buccal vestibule

  • Syringe will be concealed. Submucosal injection will be adjacent to the surgical site in the buccal vestibule

  • DrugSaline (NaCl 0,9 %) (placebo)

    Syringe will be concealed. Submucosal injection will be adjacent to the surgical site in the buccal vestibule

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: at 6 hours postoperatively and then once daily for the following 6 days

Secondary outcomes

  1. Number of postoperative analgesic tablets consumed

    The total number of rescue analgesic tablets consumed postoperatively will be recorded daily following the implant surgery

    Time frame: Postoperatively for 7 days

  2. 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.

    Time frame: Anxiety will be assessed preoperatively on the day of the surgery before implant placement

07

Study locations

1 of 1 sites recruiting
  • Al Nahdha Hospital
    Muscat, Oman
    Recruiting
    • Nasser Al Khaldi, Senior Consultant Prostho · Contactdent2020@gmail.com · +968 92898987
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07413055
Lead sponsor
Oman Ministry of Health
Responsible party
Shurooq Al-Hinai (Principal Investigator, Oman Ministry of Health) — Principal investigator
First posted
Feb 17, 2026
Start date
Mar 25, 2026 (estimated)
Primary completion
Nov 15, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Mar 30, 2026

Study contacts

Shurooq Slim Al Hinai, BDS
Contact
shurooqalhinai@gmail.com
+968 96148103
Nasser Al Khaldi, Senior Consultant Prosth
Contact
dent2020@gmail.com
+ 968 92898987

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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