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:

NCT04213716 | Completed Phase 2

• 1 other identifier: ENDO-CU-2014-9-14
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

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; Post-operative; Ache; Post Obturation

Keywords

Keywords provided by rawda mohammad abdel rahman baghdady, Cairo University:; root canal retreatment; calcium hydroxide; distilled water; silver nanoparticles; postoperative pain

Outcome Measures

Primary Outcomes (4)

• Postoperative pain using a pain-measuring scale

  Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 6 hours after the second visit (after obturation)

  [ Time Frame:6 hours ]

• Postoperative pain using a pain-measuring scale

  Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 12 hours after the second visit (after obturation)

  [ Time Frame: 12 hours ]

• Postoperative pain using a pain-measuring scale

  Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 24 hours after the second visit (after obturation)

  [ Time Frame: 24 hours ]

• Postoperative pain using a pain-measuring scale

  Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 48 hours after the second visit (after obturation)

  [ Time Frame: 48 hours ]

Study Arms (2)

intracanal medication

EXPERIMENTAL

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

Combination Product: silver nano particulate solution mixed with calcium hydroxide powder

intracanal medicament

ACTIVE COMPARATOR

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

Combination Product: conventional calcium hydroxide

Interventions

silver nano particulate solution mixed with calcium hydroxide powder COMBINATION_PRODUCT

1ml of nanosilver solution 30ppm concentration mixed with 100 mg of calcium hydroxide powder used as intracanal medication

intracanal medication

conventional calcium hydroxide COMBINATION_PRODUCT

1ml of distilled water mixed with 100 mg of calcium hydroxide powder and used as intracanal medication after root canal retreatment

intracanal medicament

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy or lactation.
• Medically compromised patients.
• Patient with multiple teeth that required retreatment to eliminate the possibility of pain referral.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Endodontic Department , Faculty of Dentistry , Cairo University

Cairo, Egypt

Location

Related Publications (26)

• 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.

  PMID: 11307374 BACKGROUND

• Daokar DS, Kalekar DA "Endodontic Failures-A Review," Journal of Dental and Medical Sciences 4(5): 5-10, 2013

  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.

  PMID: 12067129 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.

  PMID: 11556508 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.

  PMID: 18401602 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.

  PMID: 23657409 BACKGROUND

• Kawashima N, Wadachi R, Suda H, Yeng T, Parashos P. Root canal medicaments. Int Dent J. 2009 Feb;59(1):5-11.

  PMID: 19323305 BACKGROUND

• 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.

  PMID: 24461420 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.

  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.

  PMID: 21311611 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.

  PMID: 23129141 BACKGROUND

• 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.

  PMID: 16429180 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.

  PMID: 15472665 BACKGROUND

• 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.

  PMID: 24688581 BACKGROUND

• 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.

  PMID: 15614007 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.

  PMID: 25244219 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.

  PMID: 24090838 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.

  PMID: 24688576 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.

  PMID: 8626209 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.

  PMID: 15220641 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.

  PMID: 12823700 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.

  PMID: 17209826 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.

  PMID: 16037783 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.

  PMID: 17636803 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.

  PMID: 2133314 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.

  PMID: 20850681 BACKGROUND

MeSH Terms

Conditions

Pain; Pain, Postoperative

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Rawda baghdady, M.S.c

  Cairo University

  PRINCIPAL INVESTIGATOR

• Jealan El shafei, professor

  Cairo University

  STUDY DIRECTOR

• Alaa El baz, assist prof

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: cairo egypt

Model Details: 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

Study Record Dates

• First Submitted: December 21, 2019
• First Posted: December 30, 2019
• Study Start: June 15, 2015
• Primary Completion: June 1, 2016
• Study Completion: December 12, 2016
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)