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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexamethasone 4 Mg/mL Injectable Solution, Dexamethasone 8Mg Solution for Injection, Saline (NaCl 0,9 %) (placebo).
- Who it may be relevant to
- Registry conditions: Postoperative Pain. Basic parameters: 21 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Oman
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug Dexamethasone 4 Mg/mL Injectable Solution
Syringe will be concealed. Submucosal injection will be adjacent to the surgical site in the buccal vestibule - Drug Dexamethasone 8Mg Solution for Injection
Syringe will be concealed. Submucosal injection will be adjacent to the surgical site in the buccal vestibule - Drug Saline (NaCl 0,9 %) (placebo)
Syringe will be concealed. Submucosal injection will be adjacent to the surgical site in the buccal vestibule
Primary outcome measures
- Postoperative pain assessed using Visual Analog Scale (VAS) [Time frame: at 6 hours postoperatively and then once daily for the following 6 days]
Secondary outcome measures (2)
- 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]
Eligibility criteria
Inclusion criteria
- 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)
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Oman · 1 center
- Al Nahdha Hospital — Muscat
Identifiers
NCT: NCT07413055 · MoH/CSR/25/29882