Oral Health Clinical Trial
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.
Status | Recruiting |
Enrollment | 75 |
Est. completion date | |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 35 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Department of oral and maxillofacial surgery, Faculty of Dentistry, Isfahan University of Medical Sciences | Isfahan |
Lead Sponsor | Collaborator |
---|---|
Mohammad Javad Shirani | Isfahan University of Medical Sciences |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in Pain | Visual analogue scale of pain- Number of required analgesics tablets | 48 hours and one week after intervention | Yes |
Primary | Changes in Swelling | Questionnaire and VAS | 48 hours and one week after intervention | Yes |
Primary | Changes in Trismus | Questionnaire | 48 hours and one week after intervention | Yes |
Primary | Changes in General patients' satisfaction | Visual analogue scale for satisfaction | 48 hours and one week after intervention | Yes |
Primary | Changes in Quality of life | Questionnaire | 96 hours and one week after intervention | Yes |
Secondary | Trismus | Questionnaire about Maximum mouth opening- Patients complaint | one week period after the surgery | Yes |
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