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

• ClinicalTrials.gov Identifier: NCT01429935
• Recruitment Status: Unknown
• First Posted: September 7, 2011
• Last Update Posted: September 7, 2011
• Sponsor: Qazvin University Of Medical Sciences
• Information provided by (Responsible Party): farshid rayati, Qazvin University Of Medical Sciences

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Impacted Third Molar Tooth	Drug: Ginger powder; Drug: Ibuprofen; Other: placebo	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: June 2010
• Estimated Primary Completion Date: September 2011
• Estimated Study Completion Date: October 2011

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Ginger powder	Drug: Ginger powder; capsules contain 500mg Ginger powder,every 6hours,for 5 days; Other Name: zintoma
Active Comparator: Ibuprofen; capsules of Ibuprofen 400 mg	Drug: Ibuprofen; capsules of Ibuprofen 400 mg, every 6 hours for 5 days
Placebo Comparator: placebo; capsules contain starch	Other: placebo; capsules contain starch

Outcome Measures

Primary Outcome Measures :

1. Decreased amount of cheek swelling after surgery [ Time Frame: 5 days ]
   Using standard calipers, cheek thickness will be measured from the lingual aspect of the mid-portion of the crown of the mandibular 1st molar (on the same side) to the tangent of the skin of the cheek.

Secondary Outcome Measures :

1. Decreased amount of serum CRP levels [ Time Frame: 3 days ]
   A venous blood sample (approximately 4 ml, 2ml for CBC check up and 2 ml for CRP concentration) will be collected to quantitatively assess the CRP concentration after surgery and the second sample will be collected 72 hours postoperatively
2. Amount of pain severity [ Time Frame: 5 days ]
   using 100mmVAS scale,at 1 hour intervals in the first 12 hours following the surgery and every 6 hours until day 5.
3. Increased amount of Mouth opening ability [ Time Frame: 5 days ]
   assessed by measuring the distance between the upper and lower central incisal edges at maximal mouth opening on days 0 (baseline) and 1,3 and 5 post operatively.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Iran, Islamic Republic of

Qazvin University of Medical Sciences

Qazvin, Qazvin State, Iran, Islamic Republic of, 3415759811

University of Medical Science

Qazvin, Iran, Islamic Republic of

Sponsors and Collaborators

Qazvin University Of Medical Sciences

Investigators

• Study Chair: Farshid Rayati, DDS,OMFS; Assisstant professor of oral and maxillofacial dapartment
• Study Director: Fateme Hajmanuchehri; Assisstant professor of general pathology department
• Study Director: Mehran Purghasemi; General pharmacologist
• Study Director: Elnaz Najafi, DDS; General dentist
• Principal Investigator: Farshid Rayati, DDS,OMFS; Assisstant professor of oral and maxillofacial department
• Principal Investigator: Elanaz Najafi, dentist; General dentist

More Information

• Responsible Party: farshid rayati, assisstant proffessor of oral and maxillofacial department, Qazvin University Of Medical Sciences
• ClinicalTrials.gov Identifier: NCT01429935
• Other Study ID Numbers: 504
• First Posted: September 7, 2011
• Last Update Posted: September 7, 2011
• Last Verified: September 2011

Keywords provided by farshid rayati, Qazvin University Of Medical Sciences:

dental pain model; Ginger powder; CRP

Additional relevant MeSH terms:

Tooth, Impacted; Tooth Diseases; Stomatognathic Diseases; Ibuprofen; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action