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

NCT01429935 | Unknown Phase 2 DMC

• 1 other identifier: 504
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Impacted Third Molar Tooth

Keywords

dental pain model; Ginger powder; CRP

Outcome Measures

Primary Outcomes (1)

• Decreased amount of cheek swelling after surgery

  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.

  5 days

Secondary Outcomes (3)

• Decreased amount of serum CRP levels

  3 days

• Amount of pain severity

  5 days

• Increased amount of Mouth opening ability

  5 days

Study Arms (3)

Ginger powder

ACTIVE COMPARATOR

Drug: Ginger powder

Ibuprofen

ACTIVE COMPARATOR

capsules of Ibuprofen 400 mg

Drug: Ibuprofen

placebo

PLACEBO COMPARATOR

capsules contain starch

Other: placebo

Interventions

Ginger powder DRUG

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

Also known as: zintoma

Ginger powder

Ibuprofen DRUG

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

Ibuprofen

placebo OTHER

capsules contain starch

placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qazvin University Of Medical Sciences: lead

Study Sites (2)

Qazvin University of Medical Sciences

Qazvin, Qazvin State, 3415759811, Iran

Location

University of Medical Science

Qazvin, Iran

Location

MeSH Terms

Interventions

Ibuprofen

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Farshid Rayati, DDS,OMFS

  Assisstant professor of oral and maxillofacial dapartment

  STUDY CHAIR

• Fateme Hajmanuchehri

  Assisstant professor of general pathology department

  STUDY DIRECTOR

• Mehran Purghasemi

  General pharmacologist

  STUDY DIRECTOR

• Elnaz Najafi, DDS

  General dentist

  STUDY DIRECTOR

• Farshid Rayati, DDS,OMFS

  Assisstant professor of oral and maxillofacial department

  PRINCIPAL INVESTIGATOR

• Elanaz Najafi, dentist

  General dentist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assisstant proffessor of oral and maxillofacial department

Study Record Dates

• First Submitted: September 4, 2011
• First Posted: September 7, 2011
• Study Start: June 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: October 1, 2011
• Last Updated: September 7, 2011

Record last verified: 2011-09

Locations

IR (2)