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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01896427
Enrollment
75
Registered
2013-07-11
Start date
2013-04-30
Completion date
Unknown
Last updated
2013-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Molar, Third, Oral Health

Keywords

Third Molar, Edema, pain, trismus

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.

Interventions

DRUG21-benzyloxy-9alpha-fluoro-16alpha-methylpregna-1,4-dien-11beta,17alpha-diol-3,20-dione

single dose of dexamethasone (8mg) will injected

Sponsors

Isfahan University of Medical Sciences
CollaboratorOTHER
Mohammad Javad Shirani
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in Swelling48 hours and one week after interventionQuestionnaire and VAS
Changes in Trismus48 hours and one week after interventionQuestionnaire
Changes in General patients' satisfaction48 hours and one week after interventionVisual analogue scale for satisfaction
Changes in Quality of life96 hours and one week after interventionQuestionnaire
Changes in Pain48 hours and one week after interventionVisual analogue scale of pain- Number of required analgesics tablets

Secondary

MeasureTime frameDescription
Trismusone week period after the surgeryQuestionnaire about Maximum mouth opening- Patients complaint

Countries

Iran

Contacts

Primary ContactMohammadjavad Shirani, Dr
javaad.sh_f@yahoo.com00989356039479

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026