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Different Concentrations of Sodium Hypochlorite Affecting Post-endodontic Pain (NaOCl)

Primary Purpose

Post Operative Pain

Status
Recruiting
Phase
Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
Irrigation Solution
Sponsored by
Armed Forces Institute of Dentistry, Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy individuals between 18 to 55 years First and second mandibular molar diagnosed with irreversible pulpitis due to caries Patients with moderate pain will be selected, VAS score (4 - 6). Normal periapical radiographic appearance Mild tender to percussion No allergies to articaine Exclusion Criteria: Patients who have taken analgesic or anti-inflammatory drugs within 6 hours before treatment visit Pregnant or lactating patients Teeth with severe periodontal disease Teeth that cannot be isolated with rubber dam Teeth undergone over-instrumentation or overfilling beyond apex Teeth with calcifications/ resorptive defects History of allergy to any materials used in the study

Sites / Locations

  • Armed Forces Institue Of DentistryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

3% NaOCl concentration group

6% NaOCl concentration group

Arm Description

Participants in this group will receive endodontic irrigation with lower conc 3% sodium hypochlorite

Participants in this group will receive endodontic irrigation with higher conc 6% sodium hypochlorite

Outcomes

Primary Outcome Measures

Post-operative pain after root canal treatment
Post-operative pain will be assessed using a self-report questionnaire using a numerical visual analogue scale (VAS) from 0 to 10. 0 = No pain 1 - 3 = Mild pain 4 - 6 = Moderate pain 7 -10 = Severe pain Pain recording will be done after 6hrs, 12hrs, 24hrs, 48hrs and 72 hrs. (Participants to be contacted by the investigator at each time point to check on them and remind them to record their pain) The given questionnaire shall be collected when the participant comes for final restoration one week later.

Secondary Outcome Measures

Full Information

First Posted
April 5, 2023
Last Updated
April 30, 2023
Sponsor
Armed Forces Institute of Dentistry, Pakistan
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1. Study Identification

Unique Protocol Identification Number
NCT05840679
Brief Title
Different Concentrations of Sodium Hypochlorite Affecting Post-endodontic Pain
Acronym
NaOCl
Official Title
Effect of Different Concentrations of Sodium Hypochlorite on Post Operative Pain Following Single Visit Root Canal Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2023 (Anticipated)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Armed Forces Institute of Dentistry, Pakistan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomized, prospective, double-blind, clinical trial to assess the effect of 3% and 6% sodium hypochlorite (NaOCl) as irrigant on postendodontic pain and rescue medication intake following single visit root canal treatment
Detailed Description
Diagnostic procedures to include history taking and clinical and radiographic examination with all findings being recorded in patient's notes. • A prolonged exaggerated response (more than 10 seconds) to a cold pulp sensibility test and a positive response to the electric pulp tester will be considered evidence for irreversible pulpitis. Patients will be asked to rate their pre-treatment pain on a visual analogue scale from 0 to 10. Patients with moderate pain will be selected, VAS score (4 - 6). ANESTHESIA Patients receive 2 cartridges of 2% Articaine with 1:80000 epinephrine in an Inferior Alveolar Nerve Block Injection Access opening, isolation and first rinse with NaOCl After access preparation, each tooth will be isolated using rubber dam. Patients will be randomly assigned to either of the following groups: 3% NaOCl or 6% NaOCl. The pulp chamber will be filled with 2mL irrigant for 2 min followed by saline irrigation. Hand Instrumentation The patency of canals will be established and an initial glidepath be prepared using size 10 and 15 K-files (Mani, Mani Inc., Tochigi, Japan) WORKING LENGHT WL will be determined using apex locator (DentaPort ZX, J.Morita USA) and confirmed radiographically to be 1 mm short of the radiographic apex. ROTARY INSTRUMENTATION Mechanical prep using a Niti rotary system (Protaper Universal, Dentsply Sirona) in a torque-controlled endodontic motor (X-Smart plus, Dentsply Maillefer) according to the manufacturer's sequence and recommendations of speed and torque. Canal prep with S1 and SX instruments in a crown-down sequence to shape the coronal two-thirds of canal. APICAL PREPARATION Apical patency will be maintained with a size 10 K file before each rotary-instrument change.The apical preparation will be done using S1, S2, F1 or F2 up to WL corresponding to tip size of F1 or F2. IRRIGATION Between instruments, the root canals will be irrigated with 2 mL of either 3% or 6% NaOCl with a 30G x 25mm side-perforated needle (Medic Endo Irrigation Needles, HDS). The tip of the needle will be kept 4mm short of WL. The needle will be repeatedly moved up and down in order to prevent locking in the canals. Volume of irrigant use after every instrumentation - 2ml Total volume of NaOCl used per canal - 8-10ml , per Tooth - 24 - 30 ml After NaOCl, canals will be flushed with 5ml normal saline irrigation. Smear layer will be removed by irrigation with 17% EDTA, (EDTA; Glycle File Prep, Dentsply Maillefer) followed by 5 mL normal saline irrigation. DRYING CANALS At the same visit, the root canals will be dried with paper points (GAPADENT Absorbent paper points) OBTURATION Shall be filled with matched size gutta-percha cones (Meta Biomed Co, Korea) and sealar (Endoplus Root Canal Sealer 13,5g President Dental Germany) using the single cone technique. Sealed with Temporary restoration (Cavit, 3M ESPE, Germany) Patients will receive a rescue bag of 10 Ibuprofen in case they have pain with instructions for ondemand use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
3% NaOCl concentration group
Arm Type
Experimental
Arm Description
Participants in this group will receive endodontic irrigation with lower conc 3% sodium hypochlorite
Arm Title
6% NaOCl concentration group
Arm Type
Experimental
Arm Description
Participants in this group will receive endodontic irrigation with higher conc 6% sodium hypochlorite
Intervention Type
Drug
Intervention Name(s)
Irrigation Solution
Other Intervention Name(s)
Root Canal Disinfection
Intervention Description
Different concentrations of NaOCl are being used as the endodontic irrigant.
Primary Outcome Measure Information:
Title
Post-operative pain after root canal treatment
Description
Post-operative pain will be assessed using a self-report questionnaire using a numerical visual analogue scale (VAS) from 0 to 10. 0 = No pain 1 - 3 = Mild pain 4 - 6 = Moderate pain 7 -10 = Severe pain Pain recording will be done after 6hrs, 12hrs, 24hrs, 48hrs and 72 hrs. (Participants to be contacted by the investigator at each time point to check on them and remind them to record their pain) The given questionnaire shall be collected when the participant comes for final restoration one week later.
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy individuals between 18 to 55 years First and second mandibular molar diagnosed with irreversible pulpitis due to caries Patients with moderate pain will be selected, VAS score (4 - 6). Normal periapical radiographic appearance Mild tender to percussion No allergies to articaine Exclusion Criteria: Patients who have taken analgesic or anti-inflammatory drugs within 6 hours before treatment visit Pregnant or lactating patients Teeth with severe periodontal disease Teeth that cannot be isolated with rubber dam Teeth undergone over-instrumentation or overfilling beyond apex Teeth with calcifications/ resorptive defects History of allergy to any materials used in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kanza Zafar, BDS
Phone
00923337808809
Email
kanzazafar6@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Abdullah, BDS
Phone
00923365747574
Email
ahmedcmh6@gmail.com
Facility Information:
Facility Name
Armed Forces Institue Of Dentistry
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kanza zafar, BDS
Phone
00923337808809
Email
kanzazafar6@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Different Concentrations of Sodium Hypochlorite Affecting Post-endodontic Pain

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