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Effect of Intracanal Cryotherapy on Postoperative Pain Using Two Different Irrigation Systems

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
intracanal cryotherapy using needle irrigation and EndoVac system
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring cryotherapy, postoperative pain, single visit, negative pressure irrigation

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18-40 years.
  • No significant present and past medical findings.
  • Mature, single rooted teeth with single canal and closed apices.
  • Symptomatic irreversible pulpitis with symptomatic apical periodontitis (moderate to severe pain according to VAS).
  • Periodontal status- healthy periodontium according to Classification of Periodontal Disease and Conditions. (i.e. code 0).

Exclusion Criteria:

  • Immature teeth with open apices.
  • Root presenting with resorption, fracture, root caries, root curvature ≥ 10°.
  • Calcified canals.
  • Pregnancy.
  • systemic disorders and taking medications
  • Perio - endo lesion

Sites / Locations

  • Maryam rafique

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

control

intracanal cryotherapy with needle irrigation

intracanal cryotherapy using Endovac system

Arm Description

single visit root canal treatment will be performed with no additional irrigation.

single visit root canal treatment will be performed with additional irrigation with cold saline using needle irrigation.

single visit root canal treatment will be performed with additional irrigation with cold saline using EndoVac system.

Outcomes

Primary Outcome Measures

incidence of postoperavtive pain after intracanal crytherapy using two different irrigation systems
visual analogue scale (VAS) was used to assess postoperative pain after the treatment.Proforma was provided to the patient which include VAS. The scale is usually a 10 cm line with clearly defined boundaries. 0= no pain,1-3=mild pain,4-6=moderate pain and 7-10=severe pain.patient marked the number according to their pain level..

Secondary Outcome Measures

Full Information

First Posted
September 3, 2021
Last Updated
September 10, 2021
Sponsor
Dow University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05051410
Brief Title
Effect of Intracanal Cryotherapy on Postoperative Pain Using Two Different Irrigation Systems
Official Title
Effect of Intracanal Cryotherapy on Postoperative Pain Using Two Different Irrigation Systems
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 15, 2019 (Actual)
Primary Completion Date
February 18, 2021 (Actual)
Study Completion Date
March 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences

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
Yes

5. Study Description

Brief Summary
this study was conducted to know the effect of intracanal cryotherapy on postoperative pain using two different irrigation systems to deliver the cold saline. method: A total of 75 patients presenting with a diagnosis of irreversible pulpitis with symptomatic apical periodontitis in single rooted teeth were included in the study and randomly divided into three groups (n=25) (i.e. Control group, cryotherapy group with needle irrigation and cryotherapy group with negative pressure irrigation system). After complete root canal cleaning and shaping, final irrigation was done with 2.5°c 0.9% physiological saline in cryotherapy groups with needle irrigation (NI) and negative pressure irrigation system (NPI) whereas in control group no additional irrigation was done. Root canal treatment was completed in single visit. Participants were asked through telephone to rate their postoperative pain intensity after root canal treatment by visual analogue scale from day 1 till day 7 on given proforma. two way repeated measures of ANOVA test were applied to know the mean difference between and among the groups.
Detailed Description
Intracanal cryotherapy is one of the methods recently used to reduce the postoperative pain. The aim of this randomized control trial was to evaluate the effect of cold saline (cryotherapy) as a final irrigant on postoperative pain with two different irrigation systems after single visit root canal treatment objective: To find out the effect of cryotherapy as a final irrigant after root canal preparation on postoperative pain using needle irrigation and negative pressure irrigation system (EndoVac). method: the intervention used in this study was intracanal cryotherapy with two different irrigation systems i.e. needle irrigation and negative pressure irrigation system(EndoVac). for cryotherapy cold saline was used at temperature of 2.5 °c. total sample size was calculated was 75 by using PASS version 11.non probability purposive sampling was used for patient recruitment. three groups were made with sample size of 25 in each group. group allocation was done by computer generated random numbers.according to inclusion and exclusion criteria patients were selected and after complete diagnosis patients were thoroughly explained about the treatment and informed consent were taken. to record the preoperative pain ,patients were provided a proforma. proforma consisted of visual analogue scale for pain record. endodontic procedure was performed by the principal investigator and it was same in all the three groups.final irrigation protocol was diferent among the groups; control group:no final irrigation was done, cryotherapy with needle irrigation: with needle irrigation cold saline was delivered,cryotherapy with EndoVac: with EndoVac cold saline was delivered. obturation in root canal was done with same protocol in all the groups.and access cavity was filled with temporary restoration. postoperative instruction was given to the patient and follow up procedure has also been explained to them. follow up was consisted of 7 days and through phone call by assessor which was blind regarding the groups. at day 7, patient were returned with proforma in which they have noted the pain score of 7 days and at the same visit temporary filling was replaced by permanent one. the principal investigator was blind regarding the postoperative pain,as it was done by some other assessor. statistical analysis was done by using SPSS v.16.the two-way ANOVA repeated measures was performed for mean comparision among and between the groups.chi-square/fischer exact test test was performed for analgesic intake.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
cryotherapy, postoperative pain, single visit, negative pressure irrigation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
subject are randomly placed into one of the three groups:control,intracanal cryotherapy with needle irrigation, intracanal cryotherapy with EndoVac system. cold saline will be used in intracanal cryotherapy for five minutes. postoperative pain will be evaluated for 7 days using visual analogue scale.
Masking
ParticipantOutcomes Assessor
Masking Description
it is doubled blinded study in which participants will be blinded. the assessor, who will assess the postoperative pain of participant will also be blinded regarding the intervention.
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
No Intervention
Arm Description
single visit root canal treatment will be performed with no additional irrigation.
Arm Title
intracanal cryotherapy with needle irrigation
Arm Type
Experimental
Arm Description
single visit root canal treatment will be performed with additional irrigation with cold saline using needle irrigation.
Arm Title
intracanal cryotherapy using Endovac system
Arm Type
Experimental
Arm Description
single visit root canal treatment will be performed with additional irrigation with cold saline using EndoVac system.
Intervention Type
Procedure
Intervention Name(s)
intracanal cryotherapy using needle irrigation and EndoVac system
Intervention Description
a cold saline will be used as final irrigant in two groups but with different irrigation systems.
Primary Outcome Measure Information:
Title
incidence of postoperavtive pain after intracanal crytherapy using two different irrigation systems
Description
visual analogue scale (VAS) was used to assess postoperative pain after the treatment.Proforma was provided to the patient which include VAS. The scale is usually a 10 cm line with clearly defined boundaries. 0= no pain,1-3=mild pain,4-6=moderate pain and 7-10=severe pain.patient marked the number according to their pain level..
Time Frame
post operative pain was assessed for 7 days after treatment,visual analogue scale was used to assess the pain

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18-40 years. No significant present and past medical findings. Mature, single rooted teeth with single canal and closed apices. Symptomatic irreversible pulpitis with symptomatic apical periodontitis (moderate to severe pain according to VAS). Periodontal status- healthy periodontium according to Classification of Periodontal Disease and Conditions. (i.e. code 0). Exclusion Criteria: Immature teeth with open apices. Root presenting with resorption, fracture, root caries, root curvature ≥ 10°. Calcified canals. Pregnancy. systemic disorders and taking medications Perio - endo lesion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maryam rafique, MDS
Organizational Affiliation
DUHS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maryam rafique
City
Karachi
State/Province
Sindh
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Intracanal Cryotherapy on Postoperative Pain Using Two Different Irrigation Systems

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