The Effect of Premedication With Curcumin on Post-endodontic Pain
Condition: Acute Pulpitis
MeSH terms: Pulpitis
Study type: Interventional

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:

        1. Make sure the tooth is out of occlusion

        2. Hot saline mouth bath

        3. When pain is moderate /severe: Anti- inflammatory: ibuprofen600 tab/8hr (6)

        4. 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
    

Intervention name(s): curcumin group:Curcumin is an ancient coloring spice . Interestingly, it has various pharmacological activities including analgesic, anti-inf; 400mg starch
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): 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; 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
Other intervention name(s): curcum-tumeric
Intervention MeSH terms: Curcumin; Analgesics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: curcumin as premedication - root canal treatment