Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06604286
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
Comparison of the Effects of Intraoral Postoperative Dexamethasone Applications After Mandibular Third Molar Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Postoperative Dexamethasone Injected Into Masseter Muscle and Pterygomandibular Space After Mandibular Third Molar Surgery Comparison of Effects on Pain Edema and Trismus
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 mg2 ml into the masseter muscle immediately after the operation in the first operation and dexamethasone 8 mg2 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 8mg2ml 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 lowhigh 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
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 mg2 ml into the masseter muscle immediately after the operation in the first operation and dexamethasone 8 mg2 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 8mg2ml 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 lowhigh 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None