Comparing Pain and Swelling After Surgical Extraction of Mandibular Third Molar in Dexamethasone Injection and Without Corticosteroid Methods

Oral Health Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01896427
• Other study ID #: 292037
• Secondary ID: 292037IRCT201304
• Status: Recruiting
• Phase: Phase 4
• First received: June 30, 2013
• Last updated: July 6, 2013
• Start date: April 2013

Study information

• Verified date: July 2013
• Source: Isfahan University of Medical Sciences
• Contact: Mohammadjavad Shirani, Dr
• Phone: 00989356039479
• Email: javaad.sh_f[@]yahoo.com
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Molar, Third
• Oral Health

Intervention

Drug:
• 21-benzyloxy-9alpha-fluoro-16alpha-methylpregna-1,4-dien-11beta,17alpha-diol-3,20-dione
single dose of dexamethasone (8mg) will injected

Locations

Country	Name	City	State
Iran, Islamic Republic of	Department of oral and maxillofacial surgery, Faculty of Dentistry, Isfahan University of Medical Sciences	Isfahan

Sponsors (2)

Lead Sponsor	Collaborator
Mohammad Javad Shirani	Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

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