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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)

Primary Purpose

Retreatment, Root Canal Retreatment, Nonsurgical Retreatment

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
silver nano particulate solution mixed with calcium hydroxide powder
conventional calcium hydroxide
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retreatment focused on measuring Keywords provided by rawda mohammad abdel rahman baghdady, Cairo University:, root canal retreatment, calcium hydroxide, distilled water, silver nanoparticles, postoperative pain

Eligibility Criteria

25 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Endodontic Department , Faculty of Dentistry , Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

intracanal medication

intracanal medicament

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)
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)
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)
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)

Secondary Outcome Measures

Full Information

First Posted
December 21, 2019
Last Updated
December 27, 2019
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04213716
Brief Title
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:
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
June 15, 2015 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
December 12, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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 .
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: 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) 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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Keywords provided by rawda mohammad abdel rahman baghdady, Cairo University:, root canal retreatment, calcium hydroxide, distilled water, silver nanoparticles, postoperative pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intracanal medication
Arm Type
Experimental
Arm Description
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
Arm Title
intracanal medicament
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Combination Product
Intervention Name(s)
silver nano particulate solution mixed with calcium hydroxide powder
Intervention Description
1ml of nanosilver solution 30ppm concentration mixed with 100 mg of calcium hydroxide powder used as intracanal medication
Intervention Type
Combination Product
Intervention Name(s)
conventional calcium hydroxide
Intervention Description
1ml of distilled water mixed with 100 mg of calcium hydroxide powder and used as intracanal medication after root canal retreatment
Primary Outcome Measure Information:
Title
Postoperative pain using a pain-measuring scale
Description
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
[ Time Frame:6 hours ]
Title
Postoperative pain using a pain-measuring scale
Description
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
[ Time Frame: 12 hours ]
Title
Postoperative pain using a pain-measuring scale
Description
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
[ Time Frame: 24 hours ]
Title
Postoperative pain using a pain-measuring scale
Description
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
[ Time Frame: 48 hours ]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rawda baghdady, M.S.c
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jealan El shafei, professor
Organizational Affiliation
Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alaa El baz, assist prof
Organizational Affiliation
Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Endodontic Department , Faculty of Dentistry , Cairo University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
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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:

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