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

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.

Study Overview

• Status: Unknown
• Conditions: Molar, Third; Oral Health
• Intervention / Treatment: Drug: 21-benzyloxy-9alpha-fluoro-16alpha-methylpregna-1,4-dien-11beta,17alpha-diol-3,20-dione

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Phase 4

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Isfahan, Iran, Islamic Republic of, 81745-319
    • Recruiting
    • Department of oral and maxillofacial surgery, Faculty of Dentistry, Isfahan University of Medical Sciences
    • Contact: Mohammadjavad Shirani, Dr; Phone Number: 00989356039479; Email: javaad.sh_f@yahoo.com
    • Principal Investigator: Mohammadjavad Shirani, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexamethazone IO; For the case group, after the inferior alveolar block injection and before starting the surgery, single dose of dexamethasone (8mg) will injected into medial pterygoid and pterygomandibular space	Drug: 21-benzyloxy-9alpha-fluoro-16alpha-methylpregna-1,4-dien-11beta,17alpha-diol-3,20-dione; single dose of dexamethasone (8mg) will injected
Active Comparator: Dexamethasone IM; For the case group, after the inferior alveolar block injection and before starting the surgery, single dose of dexamethasone (8mg) will injected into medial pterygoid and pterygomandibular space	Drug: 21-benzyloxy-9alpha-fluoro-16alpha-methylpregna-1,4-dien-11beta,17alpha-diol-3,20-dione; single dose of dexamethasone (8mg) will injected

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Pain	Visual analogue scale of pain- Number of required analgesics tablets	48 hours and one week after intervention
Changes in Swelling	Questionnaire and VAS	48 hours and one week after intervention
Changes in Trismus	Questionnaire	48 hours and one week after intervention
Changes in General patients' satisfaction	Visual analogue scale for satisfaction	48 hours and one week after intervention
Changes in Quality of life	Questionnaire	96 hours and one week after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trismus	Questionnaire about Maximum mouth opening- Patients complaint	one week period after the surgery

Collaborators and Investigators

• Sponsor: Mohammad Javad Shirani
• Collaborators: Isfahan University of Medical Sciences
• Investigators: Study Chair: Bijan Movahedian, Oral and maxillofacial surgeon, Department of oral and maxillofacial surgery, Faculty of Dentistry, Isfahan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): April 1, 2014

Study Registration Dates

• First Submitted: June 30, 2013
• First Submitted That Met QC Criteria: July 6, 2013
• First Posted (Estimate): July 11, 2013

Study Record Updates

• Last Update Posted (Estimate): July 11, 2013
• Last Update Submitted That Met QC Criteria: July 6, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: pain; Edema; trismus; Third Molar
• Other Study ID Numbers: 292037 (Other Grant/Funding Number: Isfahan University of Medical Sciences); IRCT2013042713140N1 (Registry Identifier: Iranian Registry of clinical trials)