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

NCT01896427 | Unknown Phase 4 DMC

• 2 other identifiers: 292037IRCT2013042713140N1
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Keywords

Third Molar; Edema; pain; trismus

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Trismus

  one week period after the surgery

Study Arms (2)

Dexamethazone IO

ACTIVE COMPARATOR

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

Dexamethasone IM

ACTIVE COMPARATOR

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

Interventions

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

single dose of dexamethasone (8mg) will injected

Dexamethasone IM; Dexamethazone IO

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mohammad Javad Shirani: lead
• Isfahan University of Medical Sciences: collaborator

Study Sites (1)

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

Isfahan, Isfahan, 81745-319, Iran

RECRUITING

MeSH Terms

Conditions

Edema; Pain; Trismus

Interventions

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

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Spasm; Neuromuscular Manifestations; Nervous System Diseases

Study Officials

• Bijan Movahedian, Oral and maxillofacial surgeon

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

  STUDY CHAIR

Central Study Contacts

Mohammadjavad Shirani, Dr

CONTACT

00989356039479; javaad.sh_f@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 30, 2013
• First Posted: July 11, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2014
• Last Updated: July 11, 2013

Record last verified: 2013-07

Locations

IR (1)