Comparison of the Efficacy of Calcium Hydroxide With Silver Nanoparticle and Conventional Calcium Hydroxide Intra Canal Medications on Post-Operative Pain in Symptomatic Root Canal Treatment Failure Cases:
NCT ID: NCT04213716
Last Updated: 2020-01-02
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
120 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-06-15
Study Completion Date
2016-12-12
Brief Summary
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The aim of this study is to measure and compare the effectiveness of nanosilver combined calcium hydroxide and conventional calcium hydroxide intracanal medications in reducing postoperative pain in patients with Symptomatic Root Canal treatment Failure .
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Detailed Description
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* After confirming the diagnosis and making sure that the patient conforms to all eligibility criteria, the principal investigator will enroll the patient in the study.
* The operator will complete treatment of all cases in two visits as follows:
1. First session:
* Patients will be asked to rate their pain level on NRS before treatment is started.
* Patient will be anesthetized by using nerve block local anesthesia or infiltration local anesthesia according to the tooth location in mandibular or maxillary arch respectively.
* Previous coronal restoration will be removed:
* If the access will be cut through metal (amalgam alloy or cast metal) or composite resin, carbide fissure bur will be used.
* In case of porcelain fused to metal (PFM) crown a round diamond is used to cut through the porcelain layer, then Transmetal bur is used to cut through and remove the core material.
* Teeth will be isolated with rubber dam.
* Gutta percha removal will be done using protaper rotary retreatment files in the following manner D1 has a cutting tip to facilitate initial penetration into the filling material (coronal third). D2 and D3 both have non-cutting tips and are used to remove material from the middle and apical thirds, respectively using gutta percha solvent
* Working length will be determined using an electronic apex locator then confirmed with intraoral periapical radiograph, to be 0.5-1 mm, shorter than radiographic apex.
* Cleaning and shaping will be done using crown down preparation technique with the use of protaper rotary files in an endodontic motor according to the manufacturer instructions, the canals will be thoroughly irrigated using 3ml of 2.5% Sodium hypochlorite between every subsequent instruments.
* MD-Chelcream will be used as lubricant during mechanical preparation.
* After instrumentation of the canals paper points (Protaper Paper Points) will be used for drying.
* Using Lentulo Spiral Filler, medicaments will be placed under aseptic conditions into the canals according to each group, Experimental group Ca (OH) 2 ( Ca (OH) 2with nanosilver suspension and comparison group Ca (OH) 2 with sterile water then access cavity will be closed with a temporary filling
* Patient will be instructed to call in case of severe pain in between visits, an emergency analgesics are to be prescribed to the patient (Brufen 400mg)
2. Second session:
* After 7 days, rubber dam will be placed , the temporary fillings will be removed and master apical file will be introduced in each root canal to loosen medicament and to create a space for subsequent irrigant, then each root canal will be washed with 5 mL of sterile saline, irrigated with 1 mL of 20% citric acid and again irrigated with 5 mL sterile saline.
* Dryness of the canals by paper points (Protaper Paper Points).
* Obturation will be carried out using the cold lateral condensation technique with protaper gutta percha cones and resin sealer with spreader size according to master cone size , its depth short 2 mm of the working length, and auxiliary cones size 25.
* After obturation a cotton pellet will be placed in the pulp chamber and the access cavity will be closed with a temporary filling to avoid coronal leakage.
* The patient is given a NRS and asked to rate his pain level at 6, 12, 24 \& 48 hours after root canal retreatment .
* The operator will complete treatment of all cases in two visits as follows:
1. First session:
* Patients will be asked to rate their pain level on NRS before treatment is started.
* Patient will be anesthetized by using nerve block local anesthesia or infiltration local anesthesia according to the tooth location in mandibular or maxillary arch respectively.
* Previous coronal restoration will be removed:
* If the access will be cut through metal (amalgam alloy or cast metal) or composite resin, carbide fissure bur will be used.
* In case of porcelain fused to metal (PFM) crown a round diamond is used to cut through the porcelain layer, then Transmetal bur is used to cut through and remove the core material.
* Teeth will be isolated with rubber dam.
* Gutta percha removal will be done using protaper rotary retreatment files in the following manner D1 has a cutting tip to facilitate initial penetration into the filling material (coronal third). D2 and D3 both have non-cutting tips and are used to remove material from the middle and apical thirds, respectively using gutta percha solvent
* Working length will be determined using an electronic apex locator then confirmed with intraoral periapical radiograph, to be 0.5-1 mm, shorter than radiographic apex.
* Cleaning and shaping will be done using crown down preparation technique with the use of protaper rotary files in an endodontic motor according to the manufacturer instructions, the canals will be thoroughly irrigated using 3ml of 2.5% Sodium hypochlorite between every subsequent instruments.
* MD-Chelcream will be used as lubricant during mechanical preparation.
* After instrumentation of the canals paper points (Protaper Paper Points) will be used for drying.
* Using Lentulo Spiral Filler, medicaments will be placed under aseptic conditions into the canals according to each group, Experimental group Ca (OH) 2 ( Ca (OH) 2with nanosilver suspension and comparison group Ca (OH) 2 with sterile water then access cavity will be closed with a temporary filling
* Patient will be instructed to call in case of severe pain in between visits, an emergency analgesics are to be prescribed to the patient (Brufen 400mg)
2. Second session:
* After 7 days, rubber dam will be placed , the temporary fillings will be removed and master apical file will be introduced in each root canal to loosen medicament and to create a space for subsequent irrigant, then each root canal will be washed with 5 mL of sterile saline, irrigated with 1 mL of 20% citric acid and again irrigated with 5 mL sterile saline.
* Dryness of the canals by paper points (Protaper Paper Points).
* Obturation will be carried out using the cold lateral condensation technique with protaper gutta percha cones and resin sealer with spreader size according to master cone size , its depth short 2 mm of the working length, and auxiliary cones size 25.
* After obturation a cotton pellet will be placed in the pulp chamber and the access cavity will be closed with a temporary filling to avoid coronal leakage.
* The patient is given a NRS and asked to rate his pain level at 6, 12, 24 \& 48 hours after root canal retreatment .
Conditions
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Retreatment
Root Canal Retreatment
Nonsurgical Retreatment
Endodontic Failure
Symptomatic Endodontic Failure
Nanosilver
Intracanal Medicament
Intracanal Dressing
AgNPs
Calcium Hydroxide
Ca (OH)2
Discomfort
Pain
Flare up
Postoperative
Ache
Post-operative
Post Obturation
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Interventions: (60) Intracanal medication of 1ml combined nanosilver particle solution 30ppm / 100 mg calcium hydroxide Control : (60) Intracanal medication of 100 mg powder of calcium hydroxide mixed with 1ml distilled water
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Outcome Assessors
Bottles of nanosilver solution \& distalled water will be covered and coded either A or B by assistant supervisor, and then given to the operator.
Participants will be blinded as regard to either intervention or control Participant and operator who is also the outcome assessor are blinded.
Participants will be blinded as regard to either intervention or control Participant and operator who is also the outcome assessor are blinded.
Study Groups
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intracanal medication
After instrumentation of the canals and drying , using Lentulo Spiral Filler medicaments will be placed under aseptic conditions into the canals experimental Intracanal medication of 1ml of nanosilver solution 30ppm concentration mixed with 100 mg of calcium hydroxide powder used as intracanal medication
Group Type
EXPERIMENTAL
silver nano particulate solution mixed with calcium hydroxide powder
Intervention Type
COMBINATION_PRODUCT
1ml of nanosilver solution 30ppm concentration mixed with 100 mg of calcium hydroxide powder used as intracanal medication
intracanal medicament
After instrumentation of the canals and drying , using Lentulo Spiral Filler comparator intracanal medicaments will be placed under aseptic conditions into the canals which is 100 mg Ca (OH) 2 mixed with 1ml sterile water
Group Type
ACTIVE_COMPARATOR
conventional calcium hydroxide
Intervention Type
COMBINATION_PRODUCT
1ml of distilled water mixed with 100 mg of calcium hydroxide powder and used as intracanal medication after root canal retreatment
Interventions
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silver nano particulate solution mixed with calcium hydroxide powder
1ml of nanosilver solution 30ppm concentration mixed with 100 mg of calcium hydroxide powder used as intracanal medication
Intervention Type
COMBINATION_PRODUCT
conventional calcium hydroxide
1ml of distilled water mixed with 100 mg of calcium hydroxide powder and used as intracanal medication after root canal retreatment
Intervention Type
COMBINATION_PRODUCT
Eligibility Criteria
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Inclusion Criteria
* Medically free patients.
* Patient's age between 25-50 years.
* Anterior or premolar teeth diagnosed clinically and radio graphically as symptomatic root canal treatment failure.
* Positive patient's acceptance for participation in the study.
* Sex include both male and female.
* Patients who can understand Numerical Rating Scale (NRS)
* Patients able to sign informed consent.
* Patient's age between 25-50 years.
* Anterior or premolar teeth diagnosed clinically and radio graphically as symptomatic root canal treatment failure.
* Positive patient's acceptance for participation in the study.
* Sex include both male and female.
* Patients who can understand Numerical Rating Scale (NRS)
* Patients able to sign informed consent.
Exclusion Criteria
* Pregnancy or lactation.
* Medically compromised patients.
* Patient with multiple teeth that required retreatment to eliminate the possibility of pain referral.
* Medically compromised patients.
* Patient with multiple teeth that required retreatment to eliminate the possibility of pain referral.
Minimum Eligible Age
25 Years
Maximum Eligible Age
50 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Cairo University
OTHER
Sponsor Role
lead
Responsible Party
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Rawda Mohammad Abdel Rahman Baghdady
cairo egypt
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Rawda baghdady, M.S.c
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Jealan El shafei, professor
Role: STUDY_DIRECTOR
Cairo University
Alaa El baz, assist prof
Role: STUDY_CHAIR
Cairo University
Locations
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Endodontic Department , Faculty of Dentistry , Cairo University
Cairo, , Egypt
Site Status
Countries
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Egypt
References
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Siqueira JF Jr. Aetiology of root canal treatment failure: why well-treated teeth can fail. Int Endod J. 2001 Jan;34(1):1-10. doi: 10.1046/j.1365-2591.2001.00396.x.
Reference Type
BACKGROUND
Daokar DS, Kalekar DA "Endodontic Failures-A Review," Journal of Dental and Medical Sciences 4(5): 5-10, 2013
Reference Type
BACKGROUND
Siqueira JF Jr, Rocas 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. doi: 10.1097/00004770-200206000-00010.
Reference Type
BACKGROUND
Peciuliene V, Reynaud AH, Balciuniene I, Haapasalo M. Isolation of yeasts and enteric bacteria in root-filled teeth with chronic apical periodontitis. Int Endod J. 2001 Sep;34(6):429-34. doi: 10.1046/j.1365-2591.2001.00411.x.
Reference Type
BACKGROUND
Gama TG, de Oliveira JC, Abad EC, Rocas IN, Siqueira JF Jr. Postoperative pain following the use of two different intracanal medications. Clin Oral Investig. 2008 Dec;12(4):325-30. doi: 10.1007/s00784-008-0199-3. Epub 2008 Apr 10.
Reference Type
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.
Reference Type
BACKGROUND
Kawashima N, Wadachi R, Suda H, Yeng T, Parashos P. Root canal medicaments. Int Dent J. 2009 Feb;59(1):5-11.
Reference Type
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Wu D, Fan W, Kishen A, Gutmann JL, Fan B. Evaluation of the antibacterial efficacy of silver nanoparticles against Enterococcus faecalis biofilm. J Endod. 2014 Feb;40(2):285-90. doi: 10.1016/j.joen.2013.08.022. Epub 2013 Oct 1.
Reference Type
BACKGROUND
M. Mustafa, D. Jain, M. Kadri and etal. , " Role of Calcium Hydroxide in Endodontics : A Review," Global Journal of Medical and Public Health,vol. 1, no. 1, pp. 53-57, 2012.
Reference Type
BACKGROUND
Silveira CF, Cunha RS, Fontana CE, de Martin AS, Gomes BP, Motta RH, da Silveira Bueno CE. Assessment of the antibacterial activity of calcium hydroxide combined with chlorhexidine paste and other intracanal medications against bacterial pathogens. Eur J Dent. 2011 Jan;5(1):1-7.
Reference Type
BACKGROUND
Pacios MG, Silva C, Lopez ME, Cecilia M. Antibacterial action of calcium hydroxide vehicles and calcium hydroxide pastes. J Investig Clin Dent. 2012 Nov;3(4):264-70. doi: 10.1111/j.2041-1626.2012.00147.x.
Reference Type
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Vianna ME, Gomes BP, Sena NT, Zaia AA, Ferraz CC, de Souza Filho FJ. In vitro evaluation of the susceptibility of endodontic pathogens to calcium hydroxide combined with different vehicles. Braz Dent J. 2005;16(3):175-80. doi: 10.1590/s0103-64402005000300001. Epub 2006 Jan 12.
Reference Type
BACKGROUND
Yoldas O, Topuz A, Isci AS, Oztunc H. Postoperative pain after endodontic retreatment: single- versus two-visit treatment. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2004 Oct;98(4):483-7. doi: 10.1016/j.tripleo.2004.03.009.
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Adl A, Hamedi S, Sedigh Shams M, Motamedifar M, Sobhnamayan F. The ability of triple antibiotic paste and calcium hydroxide in disinfection of dentinal tubules. Iran Endod J. 2014 Spring;9(2):123-6. Epub 2014 Mar 8.
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Cwikla SJ, Belanger M, Giguere S, Progulske-Fox A, Vertucci FJ. Dentinal tubule disinfection using three calcium hydroxide formulations. J Endod. 2005 Jan;31(1):50-2. doi: 10.1097/01.don.0000134291.03828.d1.
Reference Type
BACKGROUND
Javidi M, Afkhami F, Zarei M, Ghazvini K, Rajabi O. Efficacy of a combined nanoparticulate/calcium hydroxide root canal medication on elimination of Enterococcus faecalis. Aust Endod J. 2014 Aug;40(2):61-5. doi: 10.1111/aej.12028. Epub 2013 May 12.
Reference Type
BACKGROUND
Mei L, Lu Z, Zhang W, Wu Z, Zhang X, Wang Y, Luo Y, Li C, Jia Y. Bioconjugated nanoparticles for attachment and penetration into pathogenic bacteria. Biomaterials. 2013 Dec;34(38):10328-37. doi: 10.1016/j.biomaterials.2013.09.045. Epub 2013 Sep 30.
Reference Type
BACKGROUND
Mohammadi Z, Soltani MK, Shalavi S. An update on the management of endodontic biofilms using root canal irrigants and medicaments. Iran Endod J. 2014 Spring;9(2):89-97. Epub 2014 Mar 8.
Reference Type
BACKGROUND
Imura N, Zuolo ML. Factors associated with endodontic flare-ups: a prospective study. Int Endod J. 1995 Sep;28(5):261-5. doi: 10.1111/j.1365-2591.1995.tb00311.x.
Reference Type
BACKGROUND
Seltzer S, Naidorf IJ. Flare-ups in endodontics: I. Etiological factors. 1985. J Endod. 2004 Jul;30(7):476-81; discussion 475. doi: 10.1097/00004770-200407000-00005.
Reference Type
BACKGROUND
Siqueira JF Jr. Microbial causes of endodontic flare-ups. Int Endod J. 2003 Jul;36(7):453-63. doi: 10.1046/j.1365-2591.2003.00671.x.
Reference Type
BACKGROUND
Sathorn C, Parashos P, Messer H. Antibacterial efficacy of calcium hydroxide intracanal dressing: a systematic review and meta-analysis. Int Endod J. 2007 Jan;40(1):2-10. doi: 10.1111/j.1365-2591.2006.01197.x.
Reference Type
BACKGROUND
Caliskan MK. Nonsurgical retreatment of teeth with periapical lesions previously managed by either endodontic or surgical intervention. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 Aug;100(2):242-8. doi: 10.1016/j.tripleo.2004.09.014.
Reference Type
BACKGROUND
Del Fabbro M, Taschieri S, Testori T, Francetti L, Weinstein RL. Surgical versus non-surgical endodontic re-treatment for periradicular lesions. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD005511. doi: 10.1002/14651858.CD005511.pub2.
Reference Type
BACKGROUND
Trope M. Relationship of intracanal medicaments to endodontic flare-ups. Endod Dent Traumatol. 1990 Oct;6(5):226-9. doi: 10.1111/j.1600-9657.1990.tb00423.x.
Reference Type
BACKGROUND
Gomes-Filho JE, Silva FO, Watanabe S, Cintra LT, Tendoro KV, Dalto LG, Pacanaro SV, Lodi CS, de Melo FF. Tissue reaction to silver nanoparticles dispersion as an alternative irrigating solution. J Endod. 2010 Oct;36(10):1698-702. doi: 10.1016/j.joen.2010.07.007. Epub 2010 Aug 24.
Reference Type
BACKGROUND
Other Identifiers
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ENDO-CU-2014-9-14
Identifier Type: -
Identifier Source: org_study_id
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