CSNIMSRRT: 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:

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT04213716

Collaborator

(none)

120

Enrollment

Location

Arms

17.9

Actual Duration (Months)

6.7

Patients Per Site Per Month

Study Details

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 .

Condition or Disease	Intervention/Treatment	Phase
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	Combination Product: silver nano particulate solution mixed with calcium hydroxide powder Combination Product: conventional calcium hydroxide	Phase 2

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 .

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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 waterInterventions: (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:

Double (Participant, Outcomes 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.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 15, 2015

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Dec 12, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Postoperative pain using a pain-measuring scale [[ 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)
Postoperative pain using a pain-measuring scale [[ 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)
Postoperative pain using a pain-measuring scale [[ 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)
Postoperative pain using a pain-measuring scale [[ 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.