Anti Inflammatory and Analgesic Effect of Ginger Powder in Dental Pain Model

NCT ID: NCT01429935

Last Updated: 2011-09-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2011-10-31

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.

Conditions

Impacted Third Molar Tooth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ginger powder

Group Type: ACTIVE_COMPARATOR

Ginger powder

Intervention Type: DRUG

capsules contain 500mg Ginger powder,every 6hours,for 5 days

Ibuprofen

capsules of Ibuprofen 400 mg

Group Type: ACTIVE_COMPARATOR

Ibuprofen

Intervention Type: DRUG

capsules of Ibuprofen 400 mg, every 6 hours for 5 days

placebo

capsules contain starch

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

capsules contain starch

Interventions

Ginger powder

capsules contain 500mg Ginger powder,every 6hours,for 5 days

Intervention Type: DRUG

Ibuprofen

capsules of Ibuprofen 400 mg, every 6 hours for 5 days

Intervention Type: DRUG

placebo

capsules contain starch

Intervention Type: OTHER

Other Intervention Names

zintoma

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Qazvin University Of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

farshid rayati

assisstant proffessor of oral and maxillofacial department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Farshid Rayati, DDS,OMFS

Role: STUDY_CHAIR

Assisstant professor of oral and maxillofacial dapartment

Fateme Hajmanuchehri

Role: STUDY_DIRECTOR

Assisstant professor of general pathology department

Mehran Purghasemi

Role: STUDY_DIRECTOR

General pharmacologist

Elnaz Najafi, DDS

Role: STUDY_DIRECTOR

General dentist

Farshid Rayati, DDS,OMFS

Role: PRINCIPAL_INVESTIGATOR

Assisstant professor of oral and maxillofacial department

Elanaz Najafi, dentist

Role: PRINCIPAL_INVESTIGATOR

General dentist

Locations

Qazvin University of Medical Sciences

Qazvin, Qazvin State, Iran

University of Medical Science

Qazvin, , Iran

Countries

Iran

Other Identifiers

504

Identifier Type: -

Identifier Source: org_study_id