Clinical trial NCT01429935: Anti Inflammatory and Analgesic Effect of Ginger Powder in Dental Pain Model
Official title: Comparison of The Anti Inflammatory and Analgesic Effect of Ginger and Ibuprofen in Post Surgical Pain Model; a Randomized,Placebo-controlled,Double-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Impacted Third Molar Tooth
Keywords: dental pain model
Ginger powder
CRP
Lead sponsor: Qazvin University Of Medical Sciences
Sponsor class: OTHER
First posted: 2011-09-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ginger contains constituents with pharmacological properties similar to the novel class of dual-acting NSAIDs. Compounds in this class inhibit arachidonic acid metabolism via the cyclooxygenase (COX) and lipooxygenase (LOX) pathways. These compounds have notably fewer side effects than conventional NSAIDs and now are being investigated as a novel class of anti-inflammatory compounds. Although ginger has potentially strong anti-inflammatory components, its efficacy on acute inflammation was not assessed before. The common postoperative sequelae of surgical removal of impacted teeth are pain, trismus and swelling, related to local inflammatory reaction, with cyclooxygenase and prostaglandins playing a crucial role. NSAIDs (e.g. Ibuprofen) are effective in the management of postoperative dental pain, likely through blockage of prostaglandin synthesis and are commonly used. The efficacy of Ibuprofen in the treatment of postoperative dental pain has been evaluated in several clinical trials. However, NSAIDs are contraindicated in patients with gastrointestinal ulcers, bleeding disorders, and renal dysfunctions. Therefore, there is a need for an effective, oral analgesic with a more favorable safety profile. The primary aim of this study was to investigate the ability of Ginger powder (Zintoma, Goldaru) to reduce postoperative swelling, pain and trismus in an acute pain model.

Detailed description: Ginger, the rhizome of Zingiber officinale, has a long history of medicinal use. In traditional Chinese and Indian medicine, ginger has been used to treat a wide range of ailments including stomachache, diarrhea, nausea, asthma, respiratory disorders, toothache, gingivitis, and arthritis. Subsequent studies revealed that ginger contains constituents with pharmacological properties similar to the novel class of dual-acting NSAIDs. Compounds in this class inhibit arachidonic acid metabolism via the cyclooxygenase (COX) and lipooxygenase (LOX) pathways. These compounds have notably fewer side effects than conventional NSAIDs and now are being investigated as a novel class of anti-inflammatory compounds. Different animal studies revealed that oral dried ginger or ginger extract reduced inflammation in paw and joint swelling induced by different chemical agents, lung inflammation induced by lipopolysaccharides (LPS) and arthritis induced by collagen . Several clinical studies support the value of ginger for the treatment of osteoarthritis . In addition to alleviating pain, ginger extract has been reported to decrease joint swelling. In some of these trials it was reported that ginger relieved pain and swelling to varying degrees in patients with osteoarthritis and rheumatoid arthritis as well as those with muscular pain without causing any adverse effects during a period ranging from 3 months to 2.5 years . In one recent trial ginger was tested in primary dysmenorrhea in comparison with Ibuprofen and mefenamic acid and no significant differences was found between the three study groups in relief, stability, or aggravation of symptoms . The common postoperative sequelae of surgical removal of impacted teeth are pain, trismus and swelling, related to local inflammatory reaction, with cyclooxygenase and prostaglandins playing a crucial role. NSAIDs (e.g. Ibuprofen) are effective in the management of postoperative dental pain, likely through blockage of prostaglandin synthesis and are commonly used. The efficacy of Ibuprofen in the treatment of postoperative dental pain has been evaluated in several clinical trials . However, NSAIDs are contraindicated in patients with gastrointestinal ulcers, bleeding disorders, and renal dysfunctions. Therefore, there is a need for an effective, oral analgesic with a more favorable safety profile. The primary aim of this study was to investigate the ability of Ginger powder (Zintoma, Goldaru,Iran) to reduce postoperative swelling, pain and trismus after third molar surgery.

Eligibility criteria: Inclusion Criteria:

* Have at least one mesio-angular impacted mandibular third molar(5-7 difficulty degree)
* adults without any kind of systemic disease
* adults with at least Diploma educational degree

Exclusion Criteria:

* history of cold,fever,infection or any other inflammatory conditions during one month before surgery
* known allergy to NSAIDs ,ginger or acetaminophen
* any kind of hematopoietic or bleeding disorders
* pregnancy or lactating
* history of peptic ulceration
* history of corticosteroid use
* duration of surgery more than 30 minutes
* any infection, fever or any kind of disease cause on days 1,2 and 3 after surgery
* failure to attend for follow up
* using any kind of medication other than given drugs until day 5 post operatively
* being on anticoagulants except for mini-aspirin (72-325 mg/day)
* mentally incapable of understanding or complying with the study protocol or for failing to sign the informed consent

Primary outcomes:
measure: Decreased amount of cheek swelling after surgery
timeFrame: 5 days
Secondary outcomes:
measure: Decreased amount of serum CRP levels
timeFrame: 3 days
measure: Amount of pain severity
timeFrame: 5 days
measure: Increased amount of Mouth opening ability
timeFrame: 5 days
Other outcomes:
Locations:
city: Qazvin
country: Iran, Islamic Republic of
facility: Qazvin University of Medical Sciences
state: Qazvin State
city: Qazvin
country: Iran, Islamic Republic of
facility: University of Medical Science
Study officials:
affiliation: Assisstant professor of oral and maxillofacial dapartment
name: Farshid Rayati, DDS,OMFS
role: STUDY_CHAIR
affiliation: Assisstant professor of general pathology department
name: Fateme Hajmanuchehri
role: STUDY_DIRECTOR
affiliation: General pharmacologist
name: Mehran Purghasemi
role: STUDY_DIRECTOR
affiliation: General dentist
name: Elnaz Najafi, DDS
role: STUDY_DIRECTOR
affiliation: Assisstant professor of oral and maxillofacial department
name: Farshid Rayati, DDS,OMFS
role: PRINCIPAL_INVESTIGATOR
affiliation: General dentist
name: Elanaz Najafi, dentist
role: PRINCIPAL_INVESTIGATOR
References: