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Effects of Intracanal Cryotherapy on Endodontic Postoperative Pain

Primary Purpose

Dental Pulp Necroses, Apical Periodontitis, Post Operative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
cold saline
saline
Sponsored by
Qassim University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dental Pulp Necroses focused on measuring Cryotherapy, endodontic pain, molar teeth, root canal treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Healthy patients Patients with maxillary or mandibular molar teeth that require root canal treatment The diagnosis of pulp necrosis The presence of symptomatic apical periodontitis The presence of normal occlusion Exclusion Criteria: Previously done root canal treatment Pregnancy Presence of any systemic disease or allergic reactions Use of any analgesic or antibiotic medications within the past three days Sinus tract or local gingival swelling around the affected tooth Periodontal pocket greater than 3 mm around the affected tooth Severe periodontal disease Internal or external root resorption Broken files Over instrumentation Incomplete filling of the root canal Overfilling of the root canal

Sites / Locations

  • Muhammad Zubair AhmadRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

cold saline

saline

Arm Description

After standard chemo-mechanical preparation of the root canal, final irrigation will be performed using 20 milliliters of cold (at 2.5 degrees Celsius temperature) saline solution.

After standard chemo-mechanical preparation of the root canal, final irrigation of the root canal system will be performed using 20 milliliters of normal saline solution at room temperature.

Outcomes

Primary Outcome Measures

Postoperative pain
Postoperative pain will be measured using visual analog scale (VAS)
Postoperative pain
Postoperative pain will be measured using visual analog scale (VAS)
Postoperative pain
Postoperative pain will be measured using visual analog scale (VAS)
Postoperative pain
Postoperative pain will be measured using visual analog scale (VAS)
adverse event
If any adverse event will occur, it will be recorded
adverse event
If any adverse event will occur, it will be recorded
adverse event
If any adverse event will occur, it will be recorded
adverse event
If any adverse event will occur, it will be recorded
adverse event
If any adverse event will occur, it will be recorded
adverse event
If any adverse event will occur, it will be recorded

Secondary Outcome Measures

Full Information

First Posted
October 28, 2022
Last Updated
October 12, 2023
Sponsor
Qassim University
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1. Study Identification

Unique Protocol Identification Number
NCT05611736
Brief Title
Effects of Intracanal Cryotherapy on Endodontic Postoperative Pain
Official Title
Effects of Intracanal Cryotherapy on Postoperative Pain in Necrotic Teeth With Symptomatic Apical Periodontitis: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

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

5. Study Description

Brief Summary
The goal of this clinical trial is to evaluate the effect of cold saline (2.5 degrees Celsius) irrigation on postoperative pain in patients who require root canal treatment in molar teeth because of dead dental pulp and infection around the apex of the root of the involved teeth. This cold saline irrigation will be done after standard irrigation of the canal using a 5.25% sodium hypochlorite solution. The main questions it aims to answer are: Is there any difference in postoperative pain when final irrigation is performed using a cold saline solution compared to the irrigation using the saline solution at room temperature in patients who require dental root canal treatment of molar teeth? Because of cold saline irrigation, what type of adverse event/s may result? Participants will be asked to fill out a questionnaire before the start of the root canal treatment and record the preoperative pain using the visual analog scale (VAS). Root canal treatment will be completed in one visit. The standard procedure of root canal treatment will be followed, including irrigation of the canal using 5.25% sodium hypochlorite. As a final irrigation, either cold saline solution or a normal saline solution at room temperature will be used. The participants will be asked to fill out another questionnaire and record the presence, duration, and intensity of postoperative pain, and if painkiller medicine was taken immediately after completion of root canal treatment and at 6 hours, 12 hours, 72 hours, and 1-week intervals. The researcher will compare the effect of the final irrigation of a cold saline solution with that of a normal saline solution at room temperature on postoperative pain.
Detailed Description
Postoperative pain in root canal therapy is multifactorial in nature, including changes in periapical pressure, microbial factors, inflammatory mediators, and psychological factors. Postoperative pain in endodontics between visits or after completion of the treatment is a major concern to both patients and operators. Teeth presented with preoperative pain, irreversible pulpitis, pulp necrosis, and apical periodontitis are the most susceptible to postoperative pain The pharmacological management of pain using medications such as nonsteroidal anti-inflammatory drugs, paracetamol, or corticosteroids, despite being relatively safe, can have side effects such as gastrointestinal intolerance and renal, hepatic, and respiratory disorders such as asthma which have been reported in the literature. To avoid these secondary effects, intracanal medications, laser, and cryotherapy have been suggested in the literature. Physical and clinical evidence suggests that the application of cold may decrease pain through the mechanism of decreasing the conduction velocity of nerve signals, hemorrhage, edema, and local inflammation. An in vitro study showed that intracanal irrigation with cold saline at 2.5 degrees Celsius reduced the external root surface temperature by more than 10 degrees Celsius, which would be enough to produce the anti-inflammatory effect in peri-radicular tissues. There are very few studies done to evaluate the effect of intracanal cryotherapy on postoperative pain in root canal therapy. This clinical trial aims to assess if final irrigation using cold saline solution after standard chemo-mechanical preparation (root canal instrumentation and irrigation using 5.25% sodium hypochlorite) procedures results in any difference in the incidence and intensity of postoperative pain in patients presenting with molar teeth with necrosis of pulp and symptomatic apical periodontitis. This clinical trial will also assess the incidence of any adverse event as a result of cold saline irrigation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Pulp Necroses, Apical Periodontitis, Post Operative Pain
Keywords
Cryotherapy, endodontic pain, molar teeth, root canal treatment

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
286 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cold saline
Arm Type
Experimental
Arm Description
After standard chemo-mechanical preparation of the root canal, final irrigation will be performed using 20 milliliters of cold (at 2.5 degrees Celsius temperature) saline solution.
Arm Title
saline
Arm Type
Active Comparator
Arm Description
After standard chemo-mechanical preparation of the root canal, final irrigation of the root canal system will be performed using 20 milliliters of normal saline solution at room temperature.
Intervention Type
Other
Intervention Name(s)
cold saline
Other Intervention Name(s)
cold normal saline
Intervention Description
After standard chemo-mechanical preparation of the root canal, final irrigation will be performed using 20 milliliters of cold (at 2.5 degrees Celsius temperature) saline solution.
Intervention Type
Other
Intervention Name(s)
saline
Other Intervention Name(s)
normal saline
Intervention Description
After standard chemo-mechanical preparation of the root canal, final irrigation of the root canal will be done using normal saline solution at room temperature
Primary Outcome Measure Information:
Title
Postoperative pain
Description
Postoperative pain will be measured using visual analog scale (VAS)
Time Frame
6 hours postoperatively
Title
Postoperative pain
Description
Postoperative pain will be measured using visual analog scale (VAS)
Time Frame
24 hours postoperatively
Title
Postoperative pain
Description
Postoperative pain will be measured using visual analog scale (VAS)
Time Frame
72 hours postoperatively
Title
Postoperative pain
Description
Postoperative pain will be measured using visual analog scale (VAS)
Time Frame
1 week postoperatively
Title
adverse event
Description
If any adverse event will occur, it will be recorded
Time Frame
during the irrigation procedure
Title
adverse event
Description
If any adverse event will occur, it will be recorded
Time Frame
immediately after the irrigation procedure
Title
adverse event
Description
If any adverse event will occur, it will be recorded
Time Frame
6 hours postoperatively
Title
adverse event
Description
If any adverse event will occur, it will be recorded
Time Frame
24 hours postoperatively
Title
adverse event
Description
If any adverse event will occur, it will be recorded
Time Frame
72 hours postoperatively
Title
adverse event
Description
If any adverse event will occur, it will be recorded
Time Frame
1 week postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Healthy patients Patients with maxillary or mandibular molar teeth that require root canal treatment The diagnosis of pulp necrosis The presence of symptomatic apical periodontitis The presence of normal occlusion Exclusion Criteria: Previously done root canal treatment Pregnancy Presence of any systemic disease or allergic reactions Use of any analgesic or antibiotic medications within the past three days Sinus tract or local gingival swelling around the affected tooth Periodontal pocket greater than 3 mm around the affected tooth Severe periodontal disease Internal or external root resorption Broken files Over instrumentation Incomplete filling of the root canal Overfilling of the root canal
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Zubair Ahmad, BDS, FCPS
Phone
0163011111
Ext
10685
Email
m.muhammad@qu.edu.sa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Zubair Ahmad, BDS, FCPS
Organizational Affiliation
Qassim University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Muhammad Zubair Ahmad
City
Ar Rass
State/Province
Qassim
ZIP/Postal Code
58883
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad Zubair Ahmad, BDS, FCPS
Phone
0163011111
Ext
10685
Email
m.muhammad@qu.edu.sa

12. IPD Sharing Statement

Citations:
PubMed Identifier
26433855
Citation
Vera J, Ochoa-Rivera J, Vazquez-Carcano M, Romero M, Arias A, Sleiman P. Effect of Intracanal Cryotherapy on Reducing Root Surface Temperature. J Endod. 2015 Nov;41(11):1884-7. doi: 10.1016/j.joen.2015.08.009. Epub 2015 Oct 1.
Results Reference
background
PubMed Identifier
31337936
Citation
Alharthi AA, Aljoudi MH, Almaliki MN, Almalki MA, Sunbul MA. Effect of intra-canal cryotherapy on post-endodontic pain in single-visit RCT: A randomized controlled trial. Saudi Dent J. 2019 Jul;31(3):330-335. doi: 10.1016/j.sdentj.2019.03.004. Epub 2019 Mar 14.
Results Reference
background
PubMed Identifier
32386857
Citation
Fayyad DM, Abdelsalam N, Hashem N. Cryotherapy: A New Paradigm of Treatment in Endodontics. J Endod. 2020 Jul;46(7):936-942. doi: 10.1016/j.joen.2020.03.019. Epub 2020 May 6.
Results Reference
background
PubMed Identifier
31326055
Citation
Sadaf D. Limited Quality Evidence Suggests that Application of Cryotherapy May Be Helpful in Reducing Postoperative Pain in Root Canal Therapy in Patients With Symptomatic Apical Periodontitis. J Evid Based Dent Pract. 2019 Jun;19(2):195-197. doi: 10.1016/j.jebdp.2019.05.005. Epub 2019 May 6.
Results Reference
background
PubMed Identifier
29398090
Citation
Gundogdu EC, Arslan H. Effects of Various Cryotherapy Applications on Postoperative Pain in Molar Teeth with Symptomatic Apical Periodontitis: A Preliminary Randomized Prospective Clinical Trial. J Endod. 2018 Mar;44(3):349-354. doi: 10.1016/j.joen.2017.11.002. Epub 2018 Feb 3.
Results Reference
background
PubMed Identifier
32916207
Citation
Sadaf D, Ahmad MZ, Onakpoya IJ. Effectiveness of Intracanal Cryotherapy in Root Canal Therapy: A Systematic Review and Meta-analysis of Randomized Clinical Trials. J Endod. 2020 Dec;46(12):1811-1823.e1. doi: 10.1016/j.joen.2020.08.022. Epub 2020 Sep 8.
Results Reference
background
PubMed Identifier
29079057
Citation
Vera J, Ochoa J, Romero M, Vazquez-Carcano M, Ramos-Gregorio CO, Aguilar RR, Cruz A, Sleiman P, Arias A. Intracanal Cryotherapy Reduces Postoperative Pain in Teeth with Symptomatic Apical Periodontitis: A Randomized Multicenter Clinical Trial. J Endod. 2018 Jan;44(1):4-8. doi: 10.1016/j.joen.2017.08.038. Epub 2017 Nov 1.
Results Reference
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Effects of Intracanal Cryotherapy on Endodontic Postoperative Pain

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