The Effect of Premedication With Curcumin on Post-endodontic Pain

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Acute Pulpitis

Intervention / Treatment
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* Drug: curcumin group:Curcumin is an ancient coloring spice . Interestingly, it has various pharmacological activities including analgesic, anti-inf
* Dietary Supplement: 400mg starch


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug (400mg Curcumin) Curcumin is apice<br>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-inf<br>* 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<br>* Other names: curcum-tumeric;Dietary Supplement: 400mg starch<br>* 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<br>|
| Placebo Comparator: Starch(400mg starch) starch is sometype of carbohydrates<br>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-inf<br>* 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<br>* Other names: curcum-tumeric;Dietary Supplement: 400mg starch<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of analgesic tablets taken | counting of analgesic tablets taken from rescue medication (ibuprofen600 tab) | immediately and after 8,12,24,48 hours after completion endodontic treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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curcumin as premedication - root canal treatment