Overview

This trial is active, not recruiting.

Condition impacted third molar tooth
Treatments ginger powder, ibuprofen, placebo
Phase phase 2
Sponsor Qazvin University Of Medical Sciences
Start date June 2010
End date September 2011
Trial size 60 participants
Trial identifier NCT01429935, 504

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
ginger powder zintoma
capsules contain 500mg Ginger powder,every 6hours,for 5 days
(Active Comparator)
capsules of Ibuprofen 400 mg
ibuprofen
capsules of Ibuprofen 400 mg, every 6 hours for 5 days
(Placebo Comparator)
capsules contain starch
placebo
capsules contain starch

Primary Outcomes

Measure
Decreased amount of cheek swelling after surgery
time frame: 5 days

Secondary Outcomes

Measure
Decreased amount of serum CRP levels
time frame: 3 days
Amount of pain severity
time frame: 5 days
Increased amount of Mouth opening ability
time frame: 5 days

Eligibility Criteria

Male or female participants from 18 years up to 40 years old.

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

Additional Information

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
Principal investigator Farshid Rayati, DDS,OMFS
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2011.
Information provided to ClinicalTrials.gov by Qazvin University Of Medical Sciences.