Effect of Dexamethasone and Methylprednisolone on Pain, Swelling and Trismus After Third Molar Surgery
This study has been completed.
Sponsor:
Federal University of the Valleys of Jequitinhonha and Mucuri
Information provided by (Responsible Party):
Federal University of the Valleys of Jequitinhonha and Mucuri
ClinicalTrials.gov Identifier:
NCT01603498
First received: May 17, 2012
Last updated: May 21, 2012
Last verified: May 2012
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Purpose
The main aim of the present study was to investigate the effect of preemptive dexamethasone and methylprednisolone to prevent pain, swelling and limitation in mouth opening following third molar extraction.
| Condition | Intervention |
|---|---|
|
Pain, Edema, Trismus |
Drug: Dexamethasone Drug: Methylprednisolone |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Preemptive Effect of Dexamethasone and Methylprednisolone on Pain, Swelling and Trismus After Third Molar Surgery: a Split-mouth Randomized Triple-blind Clinical Trial |
Resource links provided by NLM:
MedlinePlus related topics:
Edema
Drug Information available for:
Dexamethasone
Prednisolone
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone sodium phosphate
Prednisolone phosphate
Dexamethasone acetate
Prednisolone sodium succinate
Methylprednisolone sodium succinate
Dexamethasone sodium phosphate
U.S. FDA Resources
Further study details as provided by Federal University of the Valleys of Jequitinhonha and Mucuri:
Primary Outcome Measures:
- Postoperative sequelae following thir molar extraction [ Time Frame: up to seven days postoperative ] [ Designated as safety issue: No ]During the postoperative intervals of 24, 48 and 72 hours and seven days, the swelling was determined using linear measures in the face and trismus by maximum mouth opening. The postoperative pain was self-recorded by the patient using visual analogue scale in 72 hours with an interval of eight hours
Secondary Outcome Measures:
- Analgesic consumption; duration of surgery [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]
| Enrollment: | 18 |
| Study Start Date: | April 2011 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Dexamethasone 8mg |
Drug: Dexamethasone
Dexamethasone 8mg
Other Name: Dexametasone acetate
|
|
Experimental: Methylprednisolone
Methylprednisolone 40mg
|
Drug: Methylprednisolone
Methylprednisolone 40mg
Other Name: Methylprednisolone
|
Detailed Description:
Third molar surgery is often associated with significant post-surgical sequelae. The trauma caused to soft and bony tissue can result in considerable pain, swelling and trismus. Symptoms begin gradually having a peak 2 days after extraction. The use of corticosteroids such as dexamethasone and methylprednisolone can be a valuable tool when performing moderate to moderately severe oral surgical procedures. No clear consensus have emerged yet regarding patient selection, dosage, timing and type of administration of steroid. In this light, this clinical trial aim to compare the effect of preemptive dexamethasone and methylprednisolone to prevent pain, swelling and limitation in mouth opening following third molar extraction.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with indication of asymptomatic bilateral extractions of lower third molars
- Aged 18 years or older;
- Have a good health and no disease;
Exclusion Criteria:
- Patients with history of any medication treatment within 15 days before the beginning of the research, history of allergy to the drugs, substances or materials used in this study, pregnancy or lactation
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01603498
Locations
| Brazil | |
| Universidade Federal dos Vales do Jequitinhonha e Mucuri | |
| Diamantina, Minas Gerais, Brazil, 39100000 | |
Sponsors and Collaborators
Federal University of the Valleys of Jequitinhonha and Mucuri
Investigators
| Principal Investigator: | Carlos Eduardo Alcântara, MsC | Federal University of the Valleys of Jequitinhonha and Mucuri |
More Information
No publications provided
| Responsible Party: | Federal University of the Valleys of Jequitinhonha and Mucuri |
| ClinicalTrials.gov Identifier: | NCT01603498 History of Changes |
| Other Study ID Numbers: | 053/10 |
| Study First Received: | May 17, 2012 |
| Last Updated: | May 21, 2012 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Federal University of the Valleys of Jequitinhonha and Mucuri:
|
pain measurement, edema, trismus |
Additional relevant MeSH terms:
|
Edema Trismus Signs and Symptoms Spasm Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases Dexamethasone acetate Methylprednisolone acetate Prednisolone acetate Dexamethasone Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone Dexamethasone 21-phosphate |
Prednisolone hemisuccinate Prednisolone phosphate BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on May 23, 2013