Comparison of the Effects of Intraoral Postoperative Dexamethasone Applications After Mandibular Third Molar Surgery

NCT06604286 | Completed Phase 4

• 1 other identifier: 23.DUS.002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Wisdom Teeth; Edema Face; Trismus; Pain, Postoperative

Keywords

Dexamethasone; Third Molar Surgery; edema; trismus; Mandibula

Outcome Measures

Primary Outcomes (5)

• Assessment of Pain

  In order to ensure standardization in the use of analgesic drugs, all patients; It was explained in writing and verbally that he should take the first medicine 1 hour after the end of the operation, and that if he had pain in the future, he could take analgesic medicine 3 times a day, one every 8 hours. The use of analgesic medication other than the specified analgesic use by the patients during the 1-week period after the surgical procedure was recorded. Pain assessment was made using VAS scales numbered from 0 to 10.

  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.

• Evaluation of Edema

  In postoperative edema evaluation; The distances between some anatomical points on the face were measured on preoperative and postoperative days 2-7 and the changes between these lengths were calculated. The tragus, soft tissue pogonion, lateral canthus of the eye, gonion point in the mandibular angle and commissure labiorum were used as anatomical reference points. In measurements; The patient was seated upright and the lengths of tragus-lateral canthus, tragus-commissura loborum, tragus-soft tissue pogonion, tragus-gonion and gonion-lateral canthus were measured with a flexible ruler and calculated linearly

  preoperative and postoperative days 2-7

• Evaluation of Trismus

  Trismus; It was evaluated using the measurement of the distances between the mesial corners of the incisal edge of the left maxillary and mandibular central teeth at maximum mouth opening, on preoperative and postoperative days 2-7.

  preoperative and postoperative days 2-7

• Evaluation of Salivary Cortisol Amount

  Saliva samples were collected from the patients immediately before the surgical procedures and on postoperative days 2 and 7. Salivary cortisol ELISA kits (ELK Biotechnology ELK8526 Human Cor(Cortisol) ELISA Kit) with a sensitivity of 1.02 ng/mL and a detection range of 3.13-200 ng/mL were used to analyze salivary cortisol.

  preoperative and postoperative days 2-7

• Evaluation of Oral Health Related Quality of Life and Patient Satisfaction After Surgery

  The OHIP-14 form was used to assess oral health-related quality of life and patient satisfaction after the surgical procedure on preoperative and postoperative days 2-7. The OHIP-14 form was used to assess seven main categories: functional limitations, physical pain, psychological discomfort, physical disability, social disability, psychological disability and handicap. In addition, the total OHIP-14 score was calculated and evaluated by summing the scores given to all questions of the oral health impact profile form.

  preoperative and postoperative days 2-7

Study Arms (2)

8 mg IM dexamethasone injection into the masseter muscle

ACTIVE COMPARATOR

Group 1 (Masseter Injection) (n=20): 8 mg IM dexamethasone injection into the masseter muscle of the patients in this group was performed. Dexamethasone injection in group 1 was made into the masseter muscle. Injection; The margo anterior of the mandible was palpated and horizontally parallel to the occlusal level of the mandibular second molar tooth and 1 cm behind the margo anterior towards the mandibular ramus. Bone contact was not taken during the injection and the injection was made by taking negative aspiration.Similar to the mandibular anesthesia technique

Drug: In this group, patients received 8 mg IM dexamethasone injection into the masseter muscle after impacted tooth surgery.

8 mg IM dexamethasone injection into the pterygomandibular cavity

ACTIVE COMPARATOR

Group 2 (Pterygomandibular Space Injection) (n=20): 8 mg IM dexamethasone injection into the pterygomandibular cavity of the patients in this group was performed. The injection given to Group 2 was directed to the region between the margo anterior of the mandible and the raphe pterygomandibularis, 1 cm above the occlusal level of the mandibular 2nd molar tooth, and the direction of the syringe from the incisal top of the opposing mandibular canine tooth to this region, and then entering the pterygomandibular cavity. Bone contact was not taken during the injection and the injection was made by taking negative aspiration

Drug: 8 mg IM dexamethasone injection into the pterygoid cavity after impacted tooth surgery.

Interventions

In this group, patients received 8 mg IM dexamethasone injection into the masseter muscle after impacted tooth surgery. DRUG

8 mg IM dexamethasone injection was given to the groups immediately after the operation area was sutured after impacted dental surgery. Dexamethasone injection in group 1 was made into the masseter muscle. injection; The margo anterior of the mandible was palpated and horizontally parallel to the occlusal level of the mandibular second molar tooth and 1 cm behind the margo anterior towards the mandibular ramus. Bone contact was not taken during the injection and the injection was made by taking negative aspiration.

Also known as: Group 1 (Masseter Injection)

8 mg IM dexamethasone injection into the masseter muscle

8 mg IM dexamethasone injection into the pterygoid cavity after impacted tooth surgery. DRUG

8 mg IM dexamethasone injection was given to the group immediately after the operation area was sutured after impacted dental surgery. Dexamethasone injection given to Group 2 was directed to the region between the margo anterior of the mandible and the raphe pterygomandibularis, 1 cm above the occlusal level of the mandibular 2nd molar tooth, and the direction of the syringe from the incisal top of the opposing mandibular canine tooth to this region, and then entering the pterygomandibular cavity.

Also known as: Group 2 (Pterygomandibular Space Injection)

8 mg IM dexamethasone injection into the pterygomandibular cavity

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Patients with no systemic disease, AAD (American Society of Anesthesiologists) class I and BMI (body mass index) below 30.
• \. Patients between the ages of 18-25 with bilaterally symmetrical and mesioangularly positioned impacted third molars in the mandible.
• \. Patients with impacted mandibular third molars in class II-B according to the Pell and Gregory classification.
• \. Patients with impacted third molars that are fully or partially retained and asymptomatic.
• \. Patients with impacted mandibular third molars that are not associated with any pathology such as cysts or tumors and do not have active perichronitis.
• \. Patients with at least 2/3 of root development completed.
• \. Patients without complaints such as active caries, periodontal disease, pain or swelling in the operation area.
• \. Patients without a history of infection or perichronitis in the operation area.

You may not qualify if:

• \. Patients with a history of allergy to dexamethasone or other drugs to be used in the study.
• \. Patients with systemic bacterial, viral, and fungal infections.
• \. Breastfeeding mothers.
• \. Patients with diagnosed or suspected pregnancies.
• \. Patients in whom corticosteroids are contraindicated.
• \. Patients who have recently been treated with anti-inflammatory drugs.
• \. Patients with cardiovascular disease.
• \. Patients with acute or chronic maxillary sinusitis.
• \. Patients who are taking medications such as antidepressants or antihistamines on a regular basis.
• \. Patients with psychiatric problems.
• \. Patients with diabetes mellitus, rheumatic diseases, hematological diseases, or liver diseases.
• \. Patients at risk of effective endocarditis.
• \. Patients who smoke.
• \. Patients who use oral contraceptives.

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

Study Sites (1)

Afyonkarahisar Health Sciences University Faculty of Dentistry, Department of Oral and Maxillofacial Surgery

Afyonkarahisar, Afyonkarahisar, 03030, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 32855917 BACKGROUND

• 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.

  PMID: 25853044 BACKGROUND

• 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.

  PMID: 23512235 BACKGROUND

• 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.

  PMID: 21845387 BACKGROUND

MeSH Terms

Conditions

Trismus; Pain, Postoperative; Edema

Condition Hierarchy (Ancestors)

Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Study Officials

• Muhammet Yasin Pektaş

  Afyonkarahisar Health Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 19, 2024
• Study Start: April 28, 2023
• Primary Completion: October 27, 2023
• Study Completion: April 27, 2024
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)