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

Primary Purpose

Impacted Third Molar Tooth

Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Ginger powder
Ibuprofen
placebo
Sponsored by
Qazvin University Of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impacted Third Molar Tooth focused on measuring dental pain model, Ginger powder, CRP

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Qazvin University of Medical Sciences
  • University of Medical Science

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Ginger powder

Ibuprofen

placebo

Arm Description

capsules of Ibuprofen 400 mg

capsules contain starch

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Decreased amount of serum CRP levels
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
Amount of pain severity
using 100mmVAS scale,at 1 hour intervals in the first 12 hours following the surgery and every 6 hours until day 5.
Increased amount of Mouth opening ability
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.

Full Information

First Posted
September 4, 2011
Last Updated
September 6, 2011
Sponsor
Qazvin University Of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01429935
Brief Title
Anti Inflammatory and Analgesic Effect of Ginger Powder in Dental Pain Model
Acronym
GPE
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

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
October 2011 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qazvin University Of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impacted Third Molar Tooth
Keywords
dental pain model, Ginger powder, CRP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ginger powder
Arm Type
Active Comparator
Arm Title
Ibuprofen
Arm Type
Active Comparator
Arm Description
capsules of Ibuprofen 400 mg
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
capsules contain starch
Intervention Type
Drug
Intervention Name(s)
Ginger powder
Other Intervention Name(s)
zintoma
Intervention Description
capsules contain 500mg Ginger powder,every 6hours,for 5 days
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
capsules of Ibuprofen 400 mg, every 6 hours for 5 days
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
capsules contain starch
Primary Outcome Measure Information:
Title
Decreased amount of cheek swelling after surgery
Description
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.
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Decreased amount of serum CRP levels
Description
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
Time Frame
3 days
Title
Amount of pain severity
Description
using 100mmVAS scale,at 1 hour intervals in the first 12 hours following the surgery and every 6 hours until day 5.
Time Frame
5 days
Title
Increased amount of Mouth opening ability
Description
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.
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farshid Rayati, DDS,OMFS
Organizational Affiliation
Assisstant professor of oral and maxillofacial dapartment
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fateme Hajmanuchehri
Organizational Affiliation
Assisstant professor of general pathology department
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mehran Purghasemi
Organizational Affiliation
General pharmacologist
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Elnaz Najafi, DDS
Organizational Affiliation
General dentist
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Farshid Rayati, DDS,OMFS
Organizational Affiliation
Assisstant professor of oral and maxillofacial department
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elanaz Najafi, dentist
Organizational Affiliation
General dentist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qazvin University of Medical Sciences
City
Qazvin
State/Province
Qazvin State
ZIP/Postal Code
3415759811
Country
Iran, Islamic Republic of
Facility Name
University of Medical Science
City
Qazvin
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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

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