Clinical trial NCT06604286: Comparison of the Effects of Intraoral Postoperative Dexamethasone Applications After Mandibular Third Molar Surgery
Official title: Postoperative Dexamethasone Injected Into Masseter Muscle and Pterygomandibular Space After Mandibular Third Molar Surgery; Comparison of Effects on Pain, Edema and Trismus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Wisdom Teeth
Edema Face
Trismus
Pain, Postoperative
Keywords: Dexamethasone
Third Molar Surgery
edema
trismus
Mandibula
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed description: Our study aims to reduce pain, edema and restricted mouth opening (trismus) that are frequently seen after impacted tooth extraction operations with steroid applied locally to the area where the operation is performed.

Our aim in this study is to compare the effectiveness of dexamethasone (steroid) applied to different areas in terms of pain, edema and trismus by injecting dexamethasone 8 mg/2 ml into the masseter muscle immediately after the operation in the first operation and dexamethasone 8 mg/2 ml into the pterygomandibular space immediately after the operation in the second (symmetrically impacted tooth) operation in volunteer patients with bilateral and symmetrically impacted lower third molars after tooth extraction surgery.

Conditions for Participation in the Study:

Regardless of gender, over 18 years of age; Volunteer patients with bilateral, symmetrical, bone-retained impacted wisdom teeth in the mandible, Volunteer patients without any systemic disease, Volunteer patients who will voluntarily sign the informed consent form, informed about the duration, purpose and requirements of the study.

Duration of the Study: In the study, your bilateral impacted teeth will be extracted at 2-week intervals. There will be check-ups on the day of the procedure, 3rd and 7th days after both procedures, and the study will last a total of 1 month for a volunteer patient.

Number of Volunteers: The number of volunteers expected to participate in the study is 20.

Treatments to be Applied in the Study: In our study, your 2 impacted mandibular third molars will be extracted and immediately after the procedure; since the area is under anesthesia, steroid medication will be injected around the extraction areas without any pain.

Interventional Methods to be Applied in the Study: In this study, dexamethasone 8mg/2ml, which is recommended as a treatment method to reduce complications after impacted tooth surgery in Oral, Dental and Maxillofacial Surgery clinics and which we routinely use in our clinic in many surgical procedures including especially difficult impacted tooth extractions (complicated tooth extraction, periodontal surgical procedures, sinus elevation, dental implant surgery, and intraoral graft applications, etc.), will be injected into two different areas (masseter muscle and pterygomandibular area) within the operation field and under the effect of anesthesia in a painless and practical way immediately after the operation; and its effects in terms of pain, edema and trismus will be compared. Experimental Parts of the Study: Volunteer patients to be included in the study will be compared with the edema, trismus and pain scale tests of the steroid injected around the operation area on both sides but in different places after the extraction of their impacted teeth at 2-week intervals. Before the procedure, at the 6th hour, 12th hour, 1st day, 2nd day and 7th day follow-ups; Pain Scale (VAS), Oral Health Impact Profile (OHIP-14) questionnaire, before the surgical procedure and at the 6th hour, 12th hour, 1st, 2nd and 7th day post-op saliva samples will be collected and the amount of salivary cortisone at these times will be measured and compared and edema and trismus (limited mouth opening) measurements will be made and evaluated in terms of different parameters and recorded in the follow-ups. Treatment Risks

Allergic reactions, low/high blood pressure and temporary facial paralysis may be observed after local anesthesia, although rare, Allergic reactions to dexamethasone may develop, although rare, Swelling or redness, discomfort in the surgical area, Redness and cracking due to tension in the corners of the mouth, Infection and delayed wound healing, Dry socket; jaw pain that usually starts a few days after surgery due to inadequate care; more common in lower jaw extractions, especially wisdom teeth.

Damage to adjacent teeth, especially in the presence of large fillings and crowns, Loss of sensation or decreased sensation in the gums, lips, tongue, teeth and tip of the jaw. It can be seen especially in teeth with roots close to the nerves, such as wisdom teeth. Numbness almost always returns to normal, but very rarely can be permanent.

Trismus; limitation of mouth opening due to inflammation or swelling. Most surgical procedures are routine and no major complications are expected. Complications that do occur are minor and easily treatable. What are your responsibilities? During the study, you must follow your doctor recommendations after the procedure and come to follow-up appointments on the 3rd and 7th days. If you encounter any problems during the study, you must notify your doctor.

Participation in this study is entirely voluntary. You can refuse to take part in the study or withdraw from the study at any stage; even in the event of refusal or withdrawal, your subsequent treatment process will be guaranteed.

Eligibility criteria: 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 such as antidepressants or antihistamines on a regular basis.

  10. Patients with psychiatric problems.

  11. Patients with diabetes mellitus, rheumatic diseases, hematological diseases, or liver diseases.

  12. Patients at risk of effective endocarditis.

  13. Patients who smoke.

  14. Patients who use oral contraceptives.

Primary outcomes:
measure: 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.
measure: Evaluation of Edema
timeFrame: preoperative and postoperative days 2-7
measure: Evaluation of Trismus
timeFrame: preoperative and postoperative days 2-7
measure: Evaluation of Salivary Cortisol Amount
timeFrame: preoperative and postoperative days 2-7
measure: Evaluation of Oral Health Related Quality of Life and Patient Satisfaction After Surgery
timeFrame: preoperative and postoperative days 2-7
Secondary outcomes:
Other outcomes:
Locations:
city: Afyonkarahisar
country: Turkey
facility: Afyonkarahisar Health Sciences University Faculty of Dentistry, Department of Oral and Maxillofacial Surgery
Study officials:
affiliation: Afyonkarahisar Health Science University
name: Muhammet Yasin Pektaş
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vivek GK, Vaibhav N, Shetty A, Mohammad I, Ahmed N, Umeshappa H. Efficacy of Various Routes of Dexamethasone Administration in Reducing Postoperative Sequelae Following Impacted Third Molar Surgery. Ann Maxillofac Surg. 2020 Jan-Jun;10(1):61-65. doi: 10.4103/ams.ams_66_19. Epub 2020 Jun 8.
citation: Chaudhary PD, Rastogi S, Gupta P, Niranjanaprasad Indra B, Thomas R, Choudhury R. Pre-emptive effect of dexamethasone injection and consumption on post-operative swelling, pain, and trismus after third molar surgery. A prospective, double blind and randomized study. J Oral Biol Craniofac Res. 2015 Jan-Apr;5(1):21-7. doi: 10.1016/j.jobcr.2015.02.001. Epub 2015 Mar 5.
citation: Bhargava D, Sreekumar K, Deshpande A. Effects of intra-space injection of Twin mix versus intraoral-submucosal, intramuscular, intravenous and per-oral administration of dexamethasone on post-operative sequelae after mandibular impacted third molar surgery: a preliminary clinical comparative study. Oral Maxillofac Surg. 2014 Sep;18(3):293-6. doi: 10.1007/s10006-013-0412-7. Epub 2013 Mar 20.
citation: Antunes AA, Avelar RL, Martins Neto EC, Frota R, Dias E. Effect of two routes of administration of dexamethasone on pain, edema, and trismus in impacted lower third molar surgery. Oral Maxillofac Surg. 2011 Dec;15(4):217-23. doi: 10.1007/s10006-011-0290-9. Epub 2011 Aug 16.