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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04213716
Other study ID # ENDO-CU-2014-9-14
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date June 15, 2015
Est. completion date December 12, 2016

Study information

Verified date December 2019
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 .


Description:

- 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 .


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date December 12, 2016
Est. primary completion date June 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 50 Years
Eligibility 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.

Exclusion Criteria:

- Pregnancy or lactation.

- Medically compromised patients.

- Patient with multiple teeth that required retreatment to eliminate the possibility of pain referral.

Study Design


Intervention

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

Locations

Country Name City State
Egypt Endodontic Department , Faculty of Dentistry , Cairo University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (26)

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. — View Citation

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. — View Citation

Cwikla SJ, Bélanger M, Giguère S, Progulske-Fox A, Vertucci FJ. Dentinal tubule disinfection using three calcium hydroxide formulations. J Endod. 2005 Jan;31(1):50-2. — View Citation

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

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. Review. Update in: Cochrane Database Syst Rev. 2016 Oct 19;10 :CD005511. — View Citation

Gama TG, de Oliveira JC, Abad EC, Rôças 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. — View Citation

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. — View Citation

Imura N, Zuolo ML. Factors associated with endodontic flare-ups: a prospective study. Int Endod J. 1995 Sep;28(5):261-5. — View Citation

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. — View Citation

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

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.

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. — View Citation

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. Review. — View Citation

Pacios MG, Silva C, López 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. — View Citation

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. — View Citation

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. Review. — View Citation

Seltzer S, Naidorf IJ. Flare-ups in endodontics: I. Etiological factors. 1985. J Endod. 2004 Jul;30(7):476-81; discussion 475. — View Citation

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. — View Citation

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. — 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

Siqueira JF Jr. Aetiology of root canal treatment failure: why well-treated teeth can fail. Int Endod J. 2001 Jan;34(1):1-10. Review. — View Citation

Siqueira JF Jr. Microbial causes of endodontic flare-ups. Int Endod J. 2003 Jul;36(7):453-63. Review. — View Citation

Trope M. Relationship of intracanal medicaments to endodontic flare-ups. Endod Dent Traumatol. 1990 Oct;6(5):226-9. — View Citation

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. Epub 2006 Jan 12. — View Citation

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. — View Citation

Yoldas O, Topuz A, Isçi 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. — View Citation

* Note: There are 26 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 ]
Primary 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 ]
Primary 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 ]
Primary 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 ]
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