Comparison of the Effects of Intraoral Postoperative Dexamethasone Applications After Mandibular … (NCT06604286) | Clinical Trial Compass
CompletedPhase 4
Comparison of the Effects of Intraoral Postoperative Dexamethasone Applications After Mandibular Third Molar Surgery
Turkey (Türkiye)20 participantsStarted 2023-04-28
Plain-language summary
The aim of this study is to comparatively evaluate the effects of dexamethasone injected into the masseter muscle and pterygomandibular space after mandibular third molar surgery on postoperative pain, edema, trismus and quality of life.
This clinical study will include 20 patients aged 18-25 years who underwent extraction of bilaterally impacted mandibular third molars in 2 consecutive sessions. The patients will randomly divide into two groups; Group 1 (n = 20) received 8 mg IM dexamethasone injection into the masseter muscle after the surgical procedure and Group 2 (n = 20) received 8 mg IM dexamethasone injection into the pterygomandibular space after the surgical procedure. Postoperative pain will record using the VAS scale at 6 hours, 12 hours, 24 hours, 2 and 7 days postoperatively. Edema, salivary cortisol and postoperative oral health quality of life and patient satisfaction will evaluate before surgery and on the 2nd and 7th days after surgery.
Who can participate
Age range
18 Years – 25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\. Patients with no systemic disease, AAD (American Society of Anesthesiologists) class I and BMI (body mass index) below 30.
2\. Patients between the ages of 18-25 with bilaterally symmetrical and mesioangularly positioned impacted third molars in the mandible.
3\. Patients with impacted mandibular third molars in class II-B according to the Pell and Gregory classification.
4\. Patients with impacted third molars that are fully or partially retained and asymptomatic.
5\. Patients with impacted mandibular third molars that are not associated with any pathology such as cysts or tumors and do not have active perichronitis.
6\. Patients with at least 2/3 of root development completed.
7\. Patients without complaints such as active caries, periodontal disease, pain or swelling in the operation area.
8\. Patients without a history of infection or perichronitis in the operation area.
Exclusion Criteria:
* 1\. Patients with a history of allergy to dexamethasone or other drugs to be used in the study.
2\. Patients with systemic bacterial, viral, and fungal infections.
3\. Breastfeeding mothers.
4\. Patients with diagnosed or suspected pregnancies.
5\. Patients in whom corticosteroids are contraindicated.
6\. Patients who have recently been treated with anti-inflammatory drugs.
7\. Patients with cardiovascular disease.
8\. Patients with acute or chronic maxillary sinusitis.
9\. Patients who are taking medications s…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of Pain
Timeframe: Patients were called for control at the 6th, 12th, 24th hour, 2nd and 7th days postoperatively, and the forms were filled out verbatim by the researcher.
2
Evaluation of Edema
Timeframe: preoperative and postoperative days 2-7
3
Evaluation of Trismus
Timeframe: preoperative and postoperative days 2-7
4
Evaluation of Salivary Cortisol Amount
Timeframe: preoperative and postoperative days 2-7
5
Evaluation of Oral Health Related Quality of Life and Patient Satisfaction After Surgery
Timeframe: preoperative and postoperative days 2-7