Health Trials

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

ConditionPostoperative Pain
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age21-80
SponsorOman Ministry of Health

About this 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.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males & females

Age range (21-80)

ASA I & II according to (American Society of Anesthesiologists) classification

Single tooth implant

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexamethasone 4 Mg/mL Injectable Solution

    Drug

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

  • Dexamethasone 8Mg Solution for Injection

    Drug

    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

Treatment groups

138 Participants
are divided into 3 treatment groups
Group A: 8mg DexamethasoneExperimental treatment 1 intervention
Group B: 4mg DexamethasoneExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oman Ministry of Health

Lead sponsor

Source ClinicalTrials.gov
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