NCT04012424

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
23 days until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

August 13, 2021

Status Verified

August 1, 2021

Enrollment Period

1 year

First QC Date

June 30, 2019

Last Update Submit

August 7, 2021

Conditions

Acute Pulpitis

Keywords

curcumin as premedication - root canal treatment

Outcome Measures

Primary Outcomes (1)

  • 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.

    immediately and after 8,12,24,48 hours after completion endodontic treatment

Secondary Outcomes (1)

  • number of analgesic tablets taken

    immediately and after 8,12,24,48 hours after completion endodontic treatment

Study Arms (2)

Drug (400mg Curcumin) Curcumin is apice

EXPERIMENTAL

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

Drug: curcumin group:Curcumin is an ancient coloring spice . Interestingly, it has various pharmacological activities including analgesic, anti-infDietary Supplement: 400mg starch

Starch(400mg starch) starch is sometype of carbohydrates

PLACEBO COMPARATOR

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

Drug: curcumin group:Curcumin is an ancient coloring spice . Interestingly, it has various pharmacological activities including analgesic, anti-infDietary Supplement: 400mg starch

Interventions

curcumin group:Curcumin is an ancient coloring spice . Interestingly, it has various pharmacological activities including analgesic, anti-infDRUG

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

Also known as: curcum-tumeric
Drug (400mg Curcumin) Curcumin is apiceStarch(400mg starch) starch is sometype of carbohydrates
400mg starchDIETARY_SUPPLEMENT

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

Drug (400mg Curcumin) Curcumin is apiceStarch(400mg starch) starch is sometype of carbohydrates

Eligibility Criteria

Age22 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Giza, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 2997245BACKGROUND

  • 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.

    PMID: 28320541BACKGROUND

  • 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.

    PMID: 21712619BACKGROUND

  • 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.

    PMID: 26843879BACKGROUND

MeSH Terms

Interventions

Starch

Intervention Hierarchy (Ancestors)

GlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesPolysaccharides

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
master candidate at endodontic department faculty of dentistry cario university

Study Record Dates

First Submitted

June 30, 2019

First Posted

July 9, 2019

Study Start

August 1, 2019

Primary Completion

August 1, 2020

Study Completion

November 1, 2020

Last Updated

August 13, 2021

Record last verified: 2021-08

Locations

EG(1)