Trial record 4 of 4 for:    Open Studies | "Trismus"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Isfahan University of Medical Sciences
Sponsor:
Collaborator:
Isfahan University of Medical Sciences
Information provided by (Responsible Party):
Mohammad Javad Shirani, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01896427
First received: June 30, 2013
Last updated: July 6, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Oral Health
Molar, Third
Drug: 21-benzyloxy-9alpha-fluoro-16alpha-methylpregna-1,4-dien-11beta,17alpha-diol-3,20-dione
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • Changes in Pain [ Time Frame: 48 hours and one week after intervention ] [ Designated as safety issue: Yes ]
    Visual analogue scale of pain- Number of required analgesics tablets

  • Changes in Swelling [ Time Frame: 48 hours and one week after intervention ] [ Designated as safety issue: Yes ]
    Questionnaire and VAS

  • Changes in Trismus [ Time Frame: 48 hours and one week after intervention ] [ Designated as safety issue: Yes ]
    Questionnaire

  • Changes in General patients' satisfaction [ Time Frame: 48 hours and one week after intervention ] [ Designated as safety issue: Yes ]
    Visual analogue scale for satisfaction

  • Changes in Quality of life [ Time Frame: 96 hours and one week after intervention ] [ Designated as safety issue: Yes ]
    Questionnaire


Secondary Outcome Measures:
  • Trismus [ Time Frame: one week period after the surgery ] [ Designated as safety issue: Yes ]
    Questionnaire about Maximum mouth opening- Patients complaint


Estimated Enrollment: 75
Study Start Date: April 2013
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01896427

Contacts
Contact: Mohammadjavad Shirani, Dr 00989356039479 javaad.sh_f@yahoo.com

Locations
Iran, Islamic Republic of
Department of oral and maxillofacial surgery, Faculty of Dentistry, Isfahan University of Medical Sciences Recruiting
Isfahan, Iran, Islamic Republic of, 81745-319
Contact: Mohammadjavad Shirani, Dr    00989356039479    javaad.sh_f@yahoo.com   
Principal Investigator: Mohammadjavad Shirani, Dr         
Sponsors and Collaborators
Mohammad Javad Shirani
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
  More Information

No publications provided

Responsible Party: Mohammad Javad Shirani, Dr, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01896427     History of Changes
Other Study ID Numbers: 292037, 292037, IRCT2013042713140N1
Study First Received: June 30, 2013
Last Updated: July 6, 2013
Health Authority: Iran: Ethics Committee

Keywords provided by Isfahan University of Medical Sciences:
Third Molar
Edema
pain
trismus

Additional relevant MeSH terms:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014