Clinical trial NCT01896427: Comparing Pain and Swelling After Surgical Extraction of Mandibular Third Molar in Dexamethasone Injection and Without Corticosteroid Methods
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Oral Health
Molar, Third
Keywords: Third Molar
Edema
pain
trismus
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Isfahan University of Medical Sciences
First posted: 2013-07-11
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In some cases, impacted wisdom teeth should be extracted. Surgical extraction of these impacted third molars may provide special complication as pain, swelling, and trismus. In previous studies, some techniques as sutureless flap closure, modified flap designing, antibiotic usage, and injection of corticosteroids were presented. These methods are reducing post operative complications to moderate level. In this study, pain, swelling, trismus, general patients' satisfaction, and associated quality of life after the surgical removal of third mandibular impacted molars will be compared while injection of dexamethasone (8mg) does not need excessive time, effort, and equipments and it will be injected in numbness area into medial pterygoid muscle and pterygomandibular space to current corticosteroid injecting non-corticosteroid methods. To achieve this aim, 75 non pregnant participants have single impacted mandibular third molar in healthy and without pericoronitis manner, after provision of written informed consent will be entered to the study. During the study, unwilling participants to continue the study and those with abnormality of wound healing process will be excluded. The included participants will be assigned into three 25-people groups. The surgeries were done by 3 same instructed experienced oral and maxillofacial residents. After the surgery pain, swelling, trismus, general patients' satisfaction, and associated quality of life were evaluated using interview of questionnaire in 48 hour, 96 hour, and one week period of time. The comparison was done between these three groups.


Eligibility criteria: Inclusion Criteria:

* Non pregnant participants have single impacted mandibular third molar in healthy and without pericoronitis manner
* They must have no contra-indication for injection of the corticosteroid and lidocaine with epinephrine
* Should not medicated by any possibly bias maker drug
* Type of the impaction, must not provide sever difficulty
* The participants should be mentally at healthy level and provide written informed consent to incorporate in the study

Exclusion Criteria:

-Unwilling participants to continue the study and those with abnormality of wound healing process

Primary outcomes:
measure: Changes in Pain
timeFrame: 48 hours and one week after intervention
measure: Changes in Swelling
timeFrame: 48 hours and one week after intervention
measure: Changes in Trismus
timeFrame: 48 hours and one week after intervention
measure: Changes in General patients' satisfaction
timeFrame: 48 hours and one week after intervention
measure: Changes in Quality of life
timeFrame: 96 hours and one week after intervention
Secondary outcomes:
measure: Trismus
timeFrame: one week period after the surgery
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Department of oral and maxillofacial surgery, Faculty of Dentistry, Isfahan University of Medical Sciences
Study officials:
affiliation: Department of oral and maxillofacial surgery, Faculty of Dentistry, Isfahan University of Medical Sciences
name: Bijan Movahedian, Oral and maxillofacial surgeon
role: STUDY_CHAIR
References: