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

NCT ID: NCT01896427

Last Updated: 2013-07-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30

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.

Conditions

Oral Health; Molar, Third

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

21-benzyloxy-9alpha-fluoro-16alpha-methylpregna-1,4-dien-11beta,17alpha-diol-3,20-dione

Intervention Type: DRUG

single dose of dexamethasone (8mg) will injected

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

Group Type: ACTIVE_COMPARATOR

21-benzyloxy-9alpha-fluoro-16alpha-methylpregna-1,4-dien-11beta,17alpha-diol-3,20-dione

Intervention Type: DRUG

single dose of dexamethasone (8mg) will injected

Interventions

21-benzyloxy-9alpha-fluoro-16alpha-methylpregna-1,4-dien-11beta,17alpha-diol-3,20-dione

single dose of dexamethasone (8mg) will injected

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Isfahan University of Medical Sciences

OTHER

Sponsor Role: collaborator

Mohammad Javad Shirani

OTHER

Sponsor Role: lead

Responsible Party

Mohammad Javad Shirani

Dr

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Bijan Movahedian, Oral and maxillofacial surgeon

Role: STUDY_CHAIR

Department of oral and maxillofacial surgery, Faculty of Dentistry, Isfahan University of Medical Sciences

Locations

Department of oral and maxillofacial surgery, Faculty of Dentistry, Isfahan University of Medical Sciences

Isfahan, Isfahan, Iran

Site Status: RECRUITING

Countries

Iran

Central Contacts

Mohammadjavad Shirani, Dr

Role: CONTACT

javaad.sh_f@yahoo.com

00989356039479

Facility Contacts

Mohammadjavad Shirani, Dr

Role: primary

javaad.sh_f@yahoo.com

00989356039479

Other Identifiers

292037

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRCT2013042713140N1

Identifier Type: REGISTRY

Identifier Source: secondary_id

292037

Identifier Type: -

Identifier Source: org_study_id