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Clinical Trials/NCT04012424
NCT04012424CompletedNot Applicable

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

Cairo University1 site in 1 country44 target enrollmentStarted: August 1, 2019Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
44
Locations
1
Primary Endpoint
change in post operative pain after single endodontic visit

Study Overview

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:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
22 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

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

Intervention: 400mg starch (Dietary Supplement)

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

Intervention: 400mg starch (Dietary Supplement)

Outcomes

Primary Outcomes

change in post operative pain after single endodontic visit

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

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 Outcomes

  • number of analgesic tablets taken(immediately and after 8,12,24,48 hours after completion endodontic treatment)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohamed Sobhy

master candidate at endodontic department faculty of dentistry cario university

Cairo University

Study Sites (1)

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