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: (CSNIMSRRT)

December 27, 2019 updated by: Rawda Mohammad Abdel Rahman Baghdady, Cairo University

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

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 .

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Endodontic Department , Faculty of Dentistry , Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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
Active Comparator: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain using a pain-measuring scale
Time Frame: [ Time Frame:6 hours ]
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
Time Frame: [ Time Frame: 12 hours ]
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
Time Frame: [ Time Frame: 24 hours ]
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
Time Frame: [ Time Frame: 48 hours ]
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 ]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Rawda baghdady, M.S.c, Cairo University
  • Study Director: Jealan El shafei, professor, Cairo University
  • Study Chair: Alaa El baz, assist prof, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

December 12, 2016

Study Registration Dates

First Submitted

December 21, 2019

First Submitted That Met QC Criteria

December 26, 2019

First Posted (Actual)

December 30, 2019

Study Record Updates

Last Update Posted (Actual)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 27, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENDO-CU-2014-9-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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