A Phase 2/3 interventional study of Dexamethasone 4 Mg/mL Injectable Solution and MethylPREDNISolone 40 Mg/mL Injectable Suspension in Inflammation, Pain, Postoperative and Trismus, sponsored by Universidad de Granada. Completed at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-06.
Sponsored by Universidad de Granada · Phase 2/3, Interventional, and Prevention
Surgical extraction of retained lower third molars is associated with the development of postoperative complications, including inflammation, trismus and postoperative pain, that lead to a decrease in patients' quality of life. Therefore, the use of drugs is essential to reduce the morbidity associated with surgery, with NSAIDs and corticosteroids being the most commonly used drugs.
Surgical extraction of retained lower third molars is associated with the development of postoperative complications, including inflammation, trismus and postoperative pain. Traditionally, NSAIDs have been used for the treatment of postoperative pain and inflammation, although corticosteroids are increasingly used in oral surgery, as they have proven to be clinically effective in reducing postoperative complications without causing serious adverse effects. Although numerous studies have been carried out comparing different corticosteroids in order to determine which of them is the most effective, there is still no clinical protocol regulating the use of these drugs in oral surgery. Therefore, this clinical trial is based on comparing two of the most studied corticosteroids used in oral surgery to date: dexamethasone and methylprednisolone.
This study is based on the preoperative administration of 8mg of dexamethasone or 40mg of methylprednisolone via submucosa, randomly, in patients undergoing surgical extraction of a retained lower third molar, to determine which of these two drugs is more effective in the prevention of inflammation, trismus and postoperative pain.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's enrollment of 84 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Universidad de Granada is the lead sponsor of 246 studies on the registry; 43 are open to participants now.
Compared within Pain, Postoperative, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Inflammation. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Preoperative administration of 40mg of methylprednisolone via submucosa
Drug: MethylPREDNISolone 40 Mg/mL Injectable Suspension
Preoperative administration of 8mg of dexamethasone via submucosa
Drug: Dexamethasone 4 Mg/mL Injectable Solution
Drug page: Dexamethasone
Preoperative submucosal administration of 8mg of dexamethasone or 40mg of methylprednisolone.
Drug page: Methylprednisolone
Preoperative submucosal administration of 8mg of dexamethasone or 40mg of methylprednisolone.
Postoperative inflammation following third molar surgical extraction
Postoperative swelling was determined by measuring tragus-chin distance, tragus-labial cleft distance and eye angle-jaw angle distance, using a millimeter ruler.
Time frame: 7 days
Postoperative trismus following third molar surgical extraction
Postoperative trismus was assessed by measuring the patient's maximum mouth opening (measuring the distance between the incisal edge of the upper central incisor and the lower central incisor) using a millimeter ruler.
Time frame: 7 days
Postoperative pain following third molar surgical extraction
Postoperative pain was measured using the Visual Analogue Scale (VAS): patients were asked to assign a numerical value from 0-100 (0 being no pain and 100 the maximum pain).
Time frame: 7 days
Plan to share: No
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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Dexamethasone · Methylprednisolone