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:

Pain Clinical Trial

— CSNIMSRRT  

Official title:

Comparison of the Efficacy of Calcium Hydroxide Combined With Silver Nano Particulate and Conventional Calcium Hydroxide Intra Canal Medications on Post-Operative Pain in Symptomatic Root Canal Treatment Failure Cases: A Randomized Clinical Trial Therapeutic Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04213716
• Other study ID #: ENDO-CU-2014-9-14
• Status: Completed
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Ache
• AgNPs
• Ca (OH)2
• Calcium Hydroxide
• Discomfort
• Endodontic Failure
• Flare up
• Intracanal Dressing
• Intracanal Medicament
• Nanosilver
• Nonsurgical Retreatment
• Pain
• Pain, Postoperative
• Post Obturation
• Post-operative
• Postoperative
• Retreatment
• Root Canal Retreatment
• Symptomatic Endodontic Failure

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)

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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

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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

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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

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* Note: There are 26 references in all — Click 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 ]