Post Operative Pain and Level of Endotoxins With Calcium Hydroxide and Calcium Hydroxide Mixed With Chlorhexidine in Treating Necrotic Teeth
Summary
The aim of this prospective in vivo randomized clinical trial to evaluate influence of combination of calcium Hydroxide (CALCIPAST Paste, Poland) and chlorhexidine Gel 2% (Gluco-Chex 2%, Cerkamed, Poland) in comparison to calcium hydroxide paste (CALCIPAST Paste, Poland) as Intracanal Medication on post operative pain (incidence, degree, duration) and reduction of bacterial endotoxins (quantitative) after endodontic treatment in single rooted necrotic teeth. According to the inclusion criteria the patients enrolled in the study and allocated randomly into three groups either combination of calcium hydroxide paste intracanal medication with 2% chlorhexidine gel. (group A) or calcium hydroxide paste intracanal medication only (group B) or mechanical preparation without intracanal medications (group C) the endodontic treatment is done at two visits. The samples of endotoxin divided into three groups: after access (S1), after mechanical instrumentations (S2), after removal intracanal medication (S3), all samples taken by a sterile paper points introduced in the root canal for the working length for 60 seconds. firstly the patient's medical and dental history is taken. the patients assign on informed consent. and then anaesthetized and access cavity performed and root canal preparation is done by Revo-s system then irrigation and intracanal medication placement inside to canal. the patient's record the post operative pain in sheet with NRS after 4, 24, 48 hours and 2 weeks after first visit. the operator will recall the patient to check the records second visit After 2 weeks from application of ICM, rubber dam will be applied then removal of the temporary dressing, then a sterile paper point (S3) will be introduced into the canals after irrigation and removal of the remnants of the intracanal medicament with the saline solution. * Removal of the paper sample to determine the endotoxin concentration. * The canals will be obturated by single cone technique using gutta percha point tapered 0.4% (Gutta percha point, Revo-S MicroMega CO., LTD, France) corresponding to the final apical size of the file and the root canal sealer will be resin sealer (Adseal, META BIOMED CO., LTD, Korea). * Pain will be assessed by numerical pain rating scale (NRS) after 14 days from the first visit (at the day of the Obturation) before the beginning of Obturation.
Timeline
- Start
- 2017-01-03
- Primary completion
- 2017-10
- Completion
- 2018-01
Publications
- Background Singh, Ripu Daman, et al.
- Background Walton RE, Holton IF Jr, Michelich R. Calcium hydroxide as an intracanal medication: effect on posttreatment pain. J Endod. 2003 Oct;29(10):627-9. doi: 10.1097/00004770-200310000-00003.
- Background Siqueira JF Jr, Rocas IN. Clinical implications and microbiology of bacterial persistence after treatment procedures. J Endod. 2008 Nov;34(11):1291-1301.e3. doi: 10.1016/j.joen.2008.07.028. Epub 2008 Sep 17.
- Background KAKEHASHI S, STANLEY HR, FITZGERALD RJ. THE EFFECTS OF SURGICAL EXPOSURES OF DENTAL PULPS IN GERM-FREE AND CONVENTIONAL LABORATORY RATS. Oral Surg Oral Med Oral Pathol. 1965 Sep;20:340-9. doi: 10.1016/0030-4220(65)90166-0. No abstract available.
- Background Zehnder M. Root canal irrigants. J Endod. 2006 May;32(5):389-98. doi: 10.1016/j.joen.2005.09.014.
- Background Gu LS, Kim JR, Ling J, Choi KK, Pashley DH, Tay FR. Review of contemporary irrigant agitation techniques and devices. J Endod. 2009 Jun;35(6):791-804. doi: 10.1016/j.joen.2009.03.010.
- Background Cardoso MG, de Oliveira LD, Koga-Ito CY, Jorge AO. Effectiveness of ozonated water on Candida albicans, Enterococcus faecalis, and endotoxins in root canals. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2008 Mar;105(3):e85-91. doi: 10.1016/j.tripleo.2007.10.006.
- Background Vianna ME, Horz HP, Conrads G, Zaia AA, Souza-Filho FJ, Gomes BP. Effect of root canal procedures on endotoxins and endodontic pathogens. Oral Microbiol Immunol. 2007 Dec;22(6):411-8. doi: 10.1111/j.1399-302X.2007.00379.x.
- Background Nair PN, Sjogren U, Krey G, Kahnberg KE, Sundqvist G. Intraradicular bacteria and fungi in root-filled, asymptomatic human teeth with therapy-resistant periapical lesions: a long-term light and electron microscopic follow-up study. J Endod. 1990 Dec;16(12):580-8. doi: 10.1016/S0099-2399(07)80201-9.
- Background Oliveira LD, Carvalho CA, Carvalho AS, Alves Jde S, Valera MC, Jorge AO. Efficacy of endodontic treatment for endotoxin reduction in primarily infected root canals and evaluation of cytotoxic effects. J Endod. 2012 Aug;38(8):1053-7. doi: 10.1016/j.joen.2012.04.015. Epub 2012 Jun 8.
- Background Valera MC, da Rosa JA, Maekawa LE, de Oliveira LD, Carvalho CA, Koga-Ito CY, Jorge AO. Action of propolis and medications against Escherichia coli and endotoxin in root canals. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Oct;110(4):e70-4. doi: 10.1016/j.tripleo.2010.01.029.
- Background Bystrom A, Sundqvist G. The antibacterial action of sodium hypochlorite and EDTA in 60 cases of endodontic therapy. Int Endod J. 1985 Jan;18(1):35-40. doi: 10.1111/j.1365-2591.1985.tb00416.x. No abstract available.
- Background Dametto FR, Ferraz CC, Gomes BP, Zaia AA, Teixeira FB, de Souza-Filho FJ. In vitro assessment of the immediate and prolonged antimicrobial action of chlorhexidine gel as an endodontic irrigant against Enterococcus faecalis. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 Jun;99(6):768-72. doi: 10.1016/j.tripleo.2004.08.026.
- Background Estrela C, Sydney GB, Pesce HF, Felippe Junior O. Dentinal diffusion of hydroxyl ions of various calcium hydroxide pastes. Braz Dent J. 1995;6(1):5-9.
- Background Gomes BP, Ferraz CC, Garrido FD, Rosalen PL, Zaia AA, Teixeira FB, de Souza-Filho FJ. Microbial susceptibility to calcium hydroxide pastes and their vehicles. J Endod. 2002 Nov;28(11):758-61. doi: 10.1097/00004770-200211000-00003.
- Background Molander A, Reit C, Dahlen G, Kvist T. Microbiological status of root-filled teeth with apical periodontitis. Int Endod J. 1998 Jan;31(1):1-7.
- Background Pinheiro ET, Gomes BP, Ferraz CC, Sousa EL, Teixeira FB, Souza-Filho FJ. Microorganisms from canals of root-filled teeth with periapical lesions. Int Endod J. 2003 Jan;36(1):1-11. doi: 10.1046/j.1365-2591.2003.00603.x.
- Background Greenstein G, Berman C, Jaffin R. Chlorhexidine. An adjunct to periodontal therapy. J Periodontol. 1986 Jun;57(6):370-7. doi: 10.1902/jop.1986.57.6.370.
- Background Ferraz CC, Gomes BP, Zaia AA, Teixeira FB, Souza-Filho FJ. In vitro assessment of the antimicrobial action and the mechanical ability of chlorhexidine gel as an endodontic irrigant. J Endod. 2001 Jul;27(7):452-5. doi: 10.1097/00004770-200107000-00004.
- Background Siqueira JF Jr, de Uzeda M. Intracanal medicaments: evaluation of the antibacterial effects of chlorhexidine, metronidazole, and calcium hydroxide associated with three vehicles. J Endod. 1997 Mar;23(3):167-9. doi: 10.1016/S0099-2399(97)80268-3.
- Background Sukawat C, Srisuwan T. A comparison of the antimicrobial efficacy of three calcium hydroxide formulations on human dentin infected with Enterococcus faecalis. J Endod. 2002 Feb;28(2):102-4. doi: 10.1097/00004770-200202000-00013.
- Background Gomes BP, Souza SF, Ferraz CC, Teixeira FB, Zaia AA, Valdrighi L, Souza-Filho FJ. Effectiveness of 2% chlorhexidine gel and calcium hydroxide against Enterococcus faecalis in bovine root dentine in vitro. Int Endod J. 2003 Apr;36(4):267-75. doi: 10.1046/j.1365-2591.2003.00634.x.
- Background Ohara P, Torabinejad M, Kettering JD. Antibacterial effects of various endodontic irrigants on selected anaerobic bacteria. Endod Dent Traumatol. 1993 Jun;9(3):95-100. doi: 10.1111/j.1600-9657.1993.tb00258.x.
- Background Heling I, Steinberg D, Kenig S, Gavrilovich I, Sela MN, Friedman M. Efficacy of a sustained-release device containing chlorhexidine and Ca(OH)2 in preventing secondary infection of dentinal tubules. Int Endod J. 1992 Jan;25(1):20-4. doi: 10.1111/j.1365-2591.1992.tb00944.x.
- Background Salzgeber RM, Brilliant JD. An in vivo evaluation of the penetration of an irrigating solution in root canals. J Endod. 1977 Oct;3(10):394-8. doi: 10.1016/S0099-2399(77)80172-6. No abstract available.
- Background Basrani B, Tjaderhane L, Santos JM, Pascon E, Grad H, Lawrence HP, Friedman S. Efficacy of chlorhexidine- and calcium hydroxide-containing medicaments against Enterococcus faecalis in vitro. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2003 Nov;96(5):618-24. doi: 10.1016/s1079-2104(03)00166-5.
- Background Evans MD, Baumgartner JC, Khemaleelakul SU, Xia T. Efficacy of calcium hydroxide: chlorhexidine paste as an intracanal medication in bovine dentin. J Endod. 2003 May;29(5):338-9. doi: 10.1097/00004770-200305000-00005.
- Background Estrela C, Holland R, Bernabe PF, de Souza V, Estrela CR. Antimicrobial potential of medicaments used in healing process in dogs' teeth with apical periodontitis. Braz Dent J. 2004;15(3):181-5. doi: 10.1590/s0103-64402004000300003. Epub 2005 Mar 18.
- Background Schafer E, Bossmann K. Antimicrobial efficacy of chlorhexidine and two calcium hydroxide formulations against Enterococcus faecalis. J Endod. 2005 Jan;31(1):53-6. doi: 10.1097/01.don.0000134209.28874.1c.
- Background Haenni S, Schmidlin PR, Mueller B, Sener B, Zehnder M. Chemical and antimicrobial properties of calcium hydroxide mixed with irrigating solutions. Int Endod J. 2003 Feb;36(2):100-5. doi: 10.1046/j.1365-2591.2003.00629.x.
- Background Gomes BP, Vianna ME, Zaia AA, Almeida JF, Souza-Filho FJ, Ferraz CC. Chlorhexidine in endodontics. Braz Dent J. 2013;24(2):89-102. doi: 10.1590/0103-6440201302188.
- Background Sinha N, Patil S, Dodwad PK, Patil AC, Singh B. Evaluation of antimicrobial efficacy of calcium hydroxide paste, chlorhexidine gel, and a combination of both as intracanal medicament: An in vivo comparative study. J Conserv Dent. 2013 Jan;16(1):65-70. doi: 10.4103/0972-0707.105302.
- Background Sousa EL, Martinho FC, Nascimento GG, Leite FR, Gomes BP. Quantification of endotoxins in infected root canals and acute apical abscess exudates: monitoring the effectiveness of root canal procedures in the reduction of endotoxins. J Endod. 2014 Feb;40(2):177-81. doi: 10.1016/j.joen.2013.10.008. Epub 2013 Dec 10.
- Background Adl A, Motamedifar M, Shams MS, Mirzaie A. Clinical investigation of the effect of calcium hydroxide intracanal dressing on bacterial lipopolysaccharide reduction from infected root canals. Aust Endod J. 2015 Apr;41(1):12-6. doi: 10.1111/aej.12054. Epub 2013 Dec 13.
- Background Singh RD, Khatter R, Bal RK, Bal CS. Intracanal medications versus placebo in reducing postoperative endodontic pain--a double-blind randomized clinical trial. Braz Dent J. 2013;24(1):25-9. doi: 10.1590/0103-6440201302039.
- Background Khattak, Yasir Khan, Shafqat Ali Shah, and Fayaz Alam.
- Background Asgary S, Eghbal MJ. Treatment outcomes of pulpotomy in permanent molars with irreversible pulpitis using biomaterials: a multi-center randomized controlled trial. Acta Odontol Scand. 2013 Jan;71(1):130-6. doi: 10.3109/00016357.2011.654251. Epub 2012 Feb 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Calcium Hydroxide | Other / unclassified | — | Other |
| Subject | Chlorhexidine | Small molecule | 2 % | Other |