Necrotic Pulp Clinical Trial
Official title:
Effect of Irrigation With Antibiotic-containing Solutions Versus Sodium Hypochlorite on Postoperative Pain and Intra-canal Bacteria in Teeth With Necrotic Pulps (a Randomized Double-blind Clinical Trial)
• The aim of this study is to compare the degree of postoperative pain and the antimicrobial effect in terms of bacterial count reduction after using co-amoxiclav-clindamycin solution versus MTAD and sodium hypochlorite irrigating solutions in patients with necrotic pulp.
Status | Not yet recruiting |
Enrollment | 51 |
Est. completion date | June 2021 |
Est. primary completion date | June 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Maxillary/mandibular single-rooted permanent teeth: - Diagnosed clinically with pulp necrosis. - Absence of spontaneous pain. - Normal/slight widening in the periodontal membrane space (PMS). - Patients' acceptance to participate in the trial. - Patients who can understand numerical rating scale (NRS) and can sign the informed consent. Exclusion Criteria: - Medically compromised patients: Pain levels and healing following treatment would be compromised as these patients show higher incidence of pain and lower healing rate. - Patients with known allergy to penicillin or penicillin derivatives. - Pregnant females: Avoid radiation exposure, anesthesia, and medication. - If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively: Might alter their pain perception. - Patients reporting bruxism or clenching: Avoid further pressure on an already inflamed tooth inducing subsequent irritation and inflammation. - Teeth that show association with acute periapical abscess and swelling: Need special treatment steps which could involve additional visits with incision and drainage. Also, it could influence initiation and progression of postoperative pain. - Greater than grade I mobility or pocket depth greater than 5mm. Need special surgical and/or periodontal therapy. - Non-restorable teeth. - Immature teeth. - Radiographic evidence of periapical radiolucency, external or internal root resorption, vertical root fracture, perforation or calcification. |
Country | Name | City | State |
---|---|---|---|
Egypt | Endodontic Department - Faculty of Dentistry - Cairo University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Agrawal V, Rao MR, Dhingra K, Gopal VR, Mohapatra A, Mohapatra A. An in vitro comparison of antimicrobial effcacy of three root canal irrigants-BioPure MTAD, 2% chlorhexidine gluconate and 5.25% sodium hypochlorite as a final rinse against E. faecalis. J Contemp Dent Pract. 2013 Sep 1;14(5):842-7. — View Citation
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El Mubarak AH, Abu-bakr NH, Ibrahim YE. Postoperative pain in multiple-visit and single-visit root canal treatment. J Endod. 2010 Jan;36(1):36-9. doi: 10.1016/j.joen.2009.09.003. — View Citation
Estrela C, Estrela CR, Barbin EL, Spanó JC, Marchesan MA, Pécora JD. Mechanism of action of sodium hypochlorite. Braz Dent J. 2002;13(2):113-7. — View Citation
Garlapati R, Venigalla BS, Surakanti JR, Thumu J, Chennamaneni KC, Kalluru RS. Comparison of the Antimicrobial Efficacy of Two Antibiotics Sparfloxacin and Augmentin as Experimental Root Canal Irrigating Solutions against Enterococcus faecalis - An Invitro Study. J Clin Diagn Res. 2016 Mar;10(3):ZC57-60. doi: 10.7860/JCDR/2016/17199.7470. Epub 2016 Mar 1. — View Citation
Grigoratos D, Knowles J, Ng YL, Gulabivala K. Effect of exposing dentine to sodium hypochlorite and calcium hydroxide on its flexural strength and elastic modulus. Int Endod J. 2001 Mar;34(2):113-9. — View Citation
Jain P, Yeluri R, Garg N, Mayall S, Rallan M, Gupta S, Pathivada L. A Comparative Evaluation of the Effectiveness of Three Different Irrigating Solution on Microorganisms in the Root Canal: An Invivo Study. J Clin Diagn Res. 2015 Dec;9(12):ZC39-42. doi: 10.7860/JCDR/2015/13133.6991. Epub 2015 Dec 1. — View Citation
Kamberi B, Bajrami D, Stavileci M, Omeragiq S, Dragidella F, Koçani F. The Antibacterial Efficacy of Biopure MTAD in Root Canal Contaminated with Enterococcus faecalis. ISRN Dent. 2012;2012:390526. Epub 2012 Aug 1. — View Citation
Kovac J, Kovac D. Effect of irrigating solutions in endodontic therapy. Bratisl Lek Listy. 2011;112(7):410-5. Review. — View Citation
Machnick TK, Torabinejad M, Munoz CA, Shabahang S. Effect of MTAD on flexural strength and modulus of elasticity of dentin. J Endod. 2003 Nov;29(11):747-50. — View Citation
McComb D, Smith DC. A preliminary scanning electron microscopic study of root canals after endodontic procedures. J Endod. 1975 Jul;1(7):238-42. — View Citation
Misuriya A, Bhardwaj A, Bhardwaj A, Aggrawal S, Kumar PP, Gajjarepu S. A comparative antimicrobial analysis of various root canal irrigating solutions on endodontic pathogens: an in vitro study. J Contemp Dent Pract. 2014 Mar 1;15(2):153-60. — View Citation
Mohammadi Z, Abbott PV. Antimicrobial substantivity of root canal irrigants and medicaments: a review. Aust Endod J. 2009 Dec;35(3):131-9. doi: 10.1111/j.1747-4477.2009.00164.x. Review. — View Citation
Mohammadi Z, Shalavi S, Giardino L, Palazzi F, Mashouf RY, Soltanian A. Antimicrobial effect of three new and two established root canal irrigation solutions. Gen Dent. 2012 Nov-Dec;60(6):534-7; quiz p.538-9. — View Citation
Pak JG, White SN. Pain prevalence and severity before, during, and after root canal treatment: a systematic review. J Endod. 2011 Apr;37(4):429-38. doi: 10.1016/j.joen.2010.12.016. Review. — View Citation
Pinheiro ET, Gomes BP, Drucker DB, Zaia AA, Ferraz CC, Souza-Filho FJ. Antimicrobial susceptibility of Enterococcus faecalis isolated from canals of root filled teeth with periapical lesions. Int Endod J. 2004 Nov;37(11):756-63. — View Citation
Saleh IM, Ruyter IE, Haapasalo M, Ørstavik D. Survival of Enterococcus faecalis in infected dentinal tubules after root canal filling with different root canal sealers in vitro. Int Endod J. 2004 Mar;37(3):193-8. — View Citation
Shabahang S, Torabinejad M. Effect of MTAD on Enterococcus faecalis-contaminated root canals of extracted human teeth. J Endod. 2003 Sep;29(9):576-9. — View Citation
Shailaja S, Bhat SS, Hegde SK. Comparison between the antibacterial efficacies of three root canal irrigating solutions: antibiotic containing irrigant, Chlorhexidine and Chlorhexidine + Cetrimide. Oral Health Dent Manag. 2013 Dec;12(4):295-9. — View Citation
Sim TP, Knowles JC, Ng YL, Shelton J, Gulabivala K. Effect of sodium hypochlorite on mechanical properties of dentine and tooth surface strain. Int Endod J. 2001 Mar;34(2):120-32. — View Citation
Siqueira JF Jr, Machado AG, Silveira RM, Lopes HP, de Uzeda M. Evaluation of the effectiveness of sodium hypochlorite used with three irrigation methods in the elimination of Enterococcus faecalis from the root canal, in vitro. Int Endod J. 1997 Jul;30(4):279-82. — View Citation
Siqueira JF Jr, Rôças IN, Favieri A, Lima KC. Chemomechanical reduction of the bacterial population in the root canal after instrumentation and irrigation with 1%, 2.5%, and 5.25% sodium hypochlorite. J Endod. 2000 Jun;26(6):331-4. — View Citation
Siqueira JF Jr, Rôças IN, Favieri A, Machado AG, Gahyva SM, Oliveira JC, Abad EC. Incidence of postoperative pain after intracanal procedures based on an antimicrobial strategy. J Endod. 2002 Jun;28(6):457-60. — View Citation
Torabinejad M, Cho Y, Khademi AA, Bakland LK, Shabahang S. The effect of various concentrations of sodium hypochlorite on the ability of MTAD to remove the smear layer. J Endod. 2003 Apr;29(4):233-9. Erratum in: J Endod. 2003 Jun;29(6):424. — View Citation
Torabinejad M, Shabahang S, Bahjri K. Effect of MTAD on postoperative discomfort: a randomized clinical trial. J Endod. 2005 Mar;31(3):171-6. — View Citation
Tulsani SG, Chikkanarasaiah N, Bethur S. An in vivo comparison of antimicrobial efficacy of sodium hypochlorite and Biopure MTAD™ against enterococcus faecalis in primary teeth: A qPCR study. J Clin Pediatr Dent. 2014 Fall;39(1):30-4. — View Citation
Zhang W, Torabinejad M, Li Y. Evaluation of cytotoxicity of MTAD using the MTT-tetrazolium method. J Endod. 2003 Oct;29(10):654-7. — View Citation
* Note: There are 27 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | postoperative pain: numerical rating scale | intensity of pain by numerical rating scale from 0 to 10 | up to 48 hours after the first visit | |
Secondary | intra-canal bacterial count | pre and post-instrumentation samples to count intra-canal bacteria (CFU/mL) | 72 hours after root canal preparation |
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