Postoperative Pain
Conditions
Keywords
Dexamethasone, Dental implants, Postoperative pain, Submucosal injection, Analgesic consumption, Anxiety
Brief 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.
Interventions
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
Sponsors
Oman Ministry of Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain assessed using Visual Analog Scale (VAS) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of postoperative analgesic tablets consumed | Postoperatively for 7 days | The total number of rescue analgesic tablets consumed postoperatively will be recorded daily following the implant surgery |
| Correlation between preoperative anxiety (GAD-7) and postoperative pain score | Anxiety will be assessed preoperatively on the day of the surgery before implant placement | 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. |
Countries
Oman
Contacts
CONTACTShurooq Slim Al Hinai, BDS
CONTACTNasser Al Khaldi, Senior Consultant Prosth
Outcome results
None listed