search
Back to results

The Effect of Premedication With Curcumin on Post-endodontic Pain

Primary Purpose

Acute Pulpitis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
curcumin group:Curcumin is an ancient coloring spice . Interestingly, it has various pharmacological activities including analgesic, anti-inf
400mg starch
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pulpitis focused on measuring curcumin as premedication - root canal treatment

Eligibility Criteria

22 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male or female
  • Patients with age range 20- 55y
  • Mandibular molars with acute pulpitis.
  • Teeth with mature root

Exclusion Criteria:

  • Pregnant or lactating females
  • Teeth with non vital pulp
  • Non- restorable teeth
  • Medically compromised patients(diabetics-bleeding disorder- hypertensive )
  • Patients with facial swelling or acute infection.
  • Previously endodontically treated teeth
  • Periodontally affected teeth.
  • Teeth with calcified root canals, root caries, internal or external root resorption, sign of crack formation and anatomic abnormalities.
  • Patients taking analgesic medication before 12hours.

Sites / Locations

  • Cairo university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Drug (400mg Curcumin) Curcumin is apice

Starch(400mg starch) starch is sometype of carbohydrates

Arm Description

Curcumin is an ancient coloring spice of Asia which is powerful antioxidant , it has hepatoprotective effect and traditionally used for many remedies . Interestingly, it has various pharmacological activities including analgesic, anti-inflammatory , It is even reported to have antimicrobial effect . Medical clinical trials reported on the analgesic effect of curcuminoids in reducing postsurgical pain osteoarthritis and rheumatoid arthritis . patients will take 400mg capsule curcumin one hour before endodontic treatment and study its effect on post endodontic pain immediately and after 8,12,24,48 hours after completion of endodontic treatment

patints taking(400mg) starch in tabelts in same shape and color of control group before endodontic treatment by one hour and post endodontic pain immediately and after 8,12,24,48 hours after treatment completion

Outcomes

Primary Outcome Measures

change in post operative pain after single endodontic visit
intenisty of postoperative pain by using VAS pain scale which is horizontal scale from0-100mm which patient will on degree of his/her pain level and investigator will measure it with ruler and convert to catogries as follow (0-4mm): no pain, (5-44mm) : mild, (45-74mm): moderate,(75-100) : severe.

Secondary Outcome Measures

number of analgesic tablets taken
counting of analgesic tablets taken from rescue medication (ibuprofen600 tab)

Full Information

First Posted
June 30, 2019
Last Updated
August 7, 2021
Sponsor
Cairo University
search

1. Study Identification

Unique Protocol Identification Number
NCT04012424
Brief Title
The Effect of Premedication With Curcumin on Post-endodontic Pain
Official Title
The Effect of Premedication With Curcumin on Post-Operative Pain in Single Visit Endodontic Treatment of Acute Pulpitis in Mandibular Molars: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
November 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Will premedication with Curcumin in single endodontic treatment in patients having acute pulpitis in mandibular molars affect post- operative pain? This the present study hopes to bring an evidence based decision on the possibility of using curcumin as a premedication to reduce post-operative pain in single visit treatment of cases with acute pulpitis
Detailed Description
The diagnostic data will be collected in a general health chart and dental history sheet by the investigator and confirmed for eligibility criteria with main supervisor. Clinical examination through visual, palpation and percussion of offending tooth is done. Pulp sensitivity test will be done for baseline comparison. It will be performed by both by electric and thermal tests on offending tooth and the contralateral. Preoperative periapical radiograph is done to evaluate pulp chamber size and shape, root and root canals and detect any per apical changes. The selected mandibular molars should have final diagnosis of acute pulpitis. Diagnostic criteria for acute pulpitis tooth: Palpation test: not sensitive & Percussion test: not sensitive &Thermal test: hypersensitive to heat or cold & Radiographic: periapical radiograph shows normal periapex • Sequence of procedural steps: The study protocol is described to the patients and they sign an informed consent . Each patient will be given pain scale chart (VAS) in order to record his /her pain level before any intervention, and then patients will be given the premedication according to the study group: Group A" intervention or Curcumin group ": (400mg Curcumin) in one capsule Group B" placebo group ": starch capsule, Both capsules of intervention and placebo groups will have the same shape, color and are prepared by Professor Doctor Mohamed Elnabarawy in the faculty of pharmacology, Cairo University. Every patient takes one capsule before endodontic treatment by one hour according to randomization sequence table prepared by the main supervisor utilizing "random.org". The researcher will give nerve block anesthesia according to the region of the tooth will be treated, ARTINIBSA 4% articaine hydrochloride 4% with 1:100,000 epinephrine as vasoconstrictor will be used. An access cavity is performed by using round bur and endo-z bur, afterwards. The tooth will be properly isolated with rubber dam. Irrigation is done with 2ml 2.5% Sodium hypochlorite (Clorox, Nobelwax Factories for chemicals, Egypt) , then canal negotiation with K-file #15 (K-file, Dentsply Maillefer , Switzerland), and working length will be determined using an electronic apex locator (iPex NSK,Japan) and confirmed radiographically, sequentionaly larger file sizes will be introduced to the working length to gague the initional apical file size. Mechanical preparation will be performed by crown-down technique using rotary M-Pro files, in an endodontic motor (Endo mate, NSK, Japan) with adjusted torque and speed according to the manufacturer's instructions ( 450 rpm -1.5 Ncm). Gauging apical diameter will be done with manual files to determine the master apical file size. If necessary; further larger apical preparation will be done with by manual files. The rotary files will be introduced inside the canal lubricated with EDTA Cream (MD-Chelcream, META BIOMED CO, Korea) The canals are thoroughly irrigated using 2.5% NaOCl between every subsequent instrument by using side vented needle, 27 gauge, with maximum depth of working length - 1mm. The irrigant is delivered having 2ml volume at a rate 1ml/30 second. Root canal is dried using sterile paper points corresponding to master cone size followed by doing master cone periapical radiograph by ViVi, S.r.I, Italy- X-ray machine and intraoral periapical Kodak Dental film, speed D, #2. Obturation of the canals is done by lateral compaction technique and master cone cementated by resin sealer (ADSEAL, META BIOMED CO., Korea). A spreader #30 will be used 2mm short of working length to allow for auxiliary cones #25, taper 2% to be added and excess will be removed with hot instrument up to cervical line followed by insertion of temporary filling to seal the access cavity. Post-operative periapical radiograph is taken after obturation. Pain will be assessed by giving the patient the pain scale (VAS) to assess pain immediately after treatment and at 8, 12,24,48 hours after the visit. VAS pain scale is horizontal scale from1-100mm.patient mark on the scale and investigator will measure with ruler and conert to cateigories as follow (0-40mm): no pain, (5-44mm) : mild, (45-74mm): moderate,(75-100) . Patients will come back at clinic after 48hours and deliver their signed scoring sheet and referred to restorative department for permanent restoration. • In case of post appointment emergency cases: The pain is recorded by pain scale and emergency treatment done according to pain severity; recording of pain scale is continued according to schedule time line. Sequence of emergency treatment includes: Make sure the tooth is out of occlusion Hot saline mouth bath When pain is moderate /severe: Anti- inflammatory: ibuprofen600 tab/8hr (6) Antibiotics (is only prescribed in presence of swelling and/or systemic manifestations as malaise or palpable lymph nodes or fever) Hibiotic 1gm tab/12hrs and Flagel 500 mg tab/12 hrs for 5 days N.B if allergic to penicillin; Dalacin C 300 mg cap/8hrs for 5days

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pulpitis
Keywords
curcumin as premedication - root canal treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug (400mg Curcumin) Curcumin is apice
Arm Type
Experimental
Arm Description
Curcumin is an ancient coloring spice of Asia which is powerful antioxidant , it has hepatoprotective effect and traditionally used for many remedies . Interestingly, it has various pharmacological activities including analgesic, anti-inflammatory , It is even reported to have antimicrobial effect . Medical clinical trials reported on the analgesic effect of curcuminoids in reducing postsurgical pain osteoarthritis and rheumatoid arthritis . patients will take 400mg capsule curcumin one hour before endodontic treatment and study its effect on post endodontic pain immediately and after 8,12,24,48 hours after completion of endodontic treatment
Arm Title
Starch(400mg starch) starch is sometype of carbohydrates
Arm Type
Placebo Comparator
Arm Description
patints taking(400mg) starch in tabelts in same shape and color of control group before endodontic treatment by one hour and post endodontic pain immediately and after 8,12,24,48 hours after treatment completion
Intervention Type
Drug
Intervention Name(s)
curcumin group:Curcumin is an ancient coloring spice . Interestingly, it has various pharmacological activities including analgesic, anti-inf
Other Intervention Name(s)
curcum-tumeric
Intervention Description
effect of taking 400mg curcumin one hour before endodontic ttt on post endodontic pain immediatelly and after 8,12,24,48 hours after endodontic treatment.Curcumin is an ancient coloring spice of Asia which is powerful antioxidant , it has hepatoprotective effect and traditionally used for many remedies . Interestingly, it has various pharmacological activities including analgesic, anti-inflammatory , It is even reported to have antimicrobial effect . Medical clinical trials reported on the analgesic effect of curcuminoids in reducing postsurgical pain osteoarthritis and rheumatoid arthritis . other name : curcum, tumeric
Intervention Type
Dietary Supplement
Intervention Name(s)
400mg starch
Intervention Description
patints taking(400mg) starch in tabelts in same shape and color of control group before endodontic treatment by one hour and post endodontic pain immediately and after 8,12,24,48 hours after treatment completion
Primary Outcome Measure Information:
Title
change in post operative pain after single endodontic visit
Description
intenisty of postoperative pain by using VAS pain scale which is horizontal scale from0-100mm which patient will on degree of his/her pain level and investigator will measure it with ruler and convert to catogries as follow (0-4mm): no pain, (5-44mm) : mild, (45-74mm): moderate,(75-100) : severe.
Time Frame
immediately and after 8,12,24,48 hours after completion endodontic treatment
Secondary Outcome Measure Information:
Title
number of analgesic tablets taken
Description
counting of analgesic tablets taken from rescue medication (ibuprofen600 tab)
Time Frame
immediately and after 8,12,24,48 hours after completion endodontic treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or female Patients with age range 20- 55y Mandibular molars with acute pulpitis. Teeth with mature root Exclusion Criteria: Pregnant or lactating females Teeth with non vital pulp Non- restorable teeth Medically compromised patients(diabetics-bleeding disorder- hypertensive ) Patients with facial swelling or acute infection. Previously endodontically treated teeth Periodontally affected teeth. Teeth with calcified root canals, root caries, internal or external root resorption, sign of crack formation and anatomic abnormalities. Patients taking analgesic medication before 12hours.
Facility Information:
Facility Name
Cairo university
City
Giza
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
2997245
Citation
Taylor H, Warfield CA. Thermography of pain: instrumentation and uses. Hosp Pract (Off Ed). 1985 Nov 15;20(11):164, 168-9. doi: 10.1080/21548331.1985.11703194. No abstract available.
Results Reference
background
PubMed Identifier
28320541
Citation
Praveen R, Thakur S, Kirthiga M. Comparative Evaluation of Premedication with Ketorolac and Prednisolone on Postendodontic Pain: A Double-blind Randomized Controlled Trial. J Endod. 2017 May;43(5):667-673. doi: 10.1016/j.joen.2016.12.012. Epub 2017 Mar 17.
Results Reference
background
PubMed Identifier
21712619
Citation
Arslan H, Topcuoglu HS, Aladag H. Effectiveness of tenoxicam and ibuprofen for pain prevention following endodontic therapy in comparison to placebo: a randomized double-blind clinical trial. J Oral Sci. 2011 Jun;53(2):157-61. doi: 10.2334/josnusd.53.157.
Results Reference
background
PubMed Identifier
26843879
Citation
Mokhtari F, Yazdi K, Mahabadi AM, Modaresi SJ, Hamzeheil Z. Effect of Premedication with Indomethacin and Ibuprofen on Postoperative Endodontic Pain: A Clinical Trial. Iran Endod J. 2016 Winter;11(1):57-62. doi: 10.7508/iej.2016.01.011. Epub 2015 Dec 24.
Results Reference
background

Learn more about this trial

The Effect of Premedication With Curcumin on Post-endodontic Pain

We'll reach out to this number within 24 hrs