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

NCT05051410 | Completed DMC

• 1 other identifier: MRafique
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

cryotherapy; postoperative pain; single visit; negative pressure irrigation

Outcome Measures

Primary Outcomes (1)

• 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..

  post operative pain was assessed for 7 days after treatment,visual analogue scale was used to assess the pain

Study Arms (3)

control

NO INTERVENTION

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

intracanal cryotherapy with needle irrigation

EXPERIMENTAL

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

Procedure: intracanal cryotherapy using needle irrigation and EndoVac system

intracanal cryotherapy using Endovac system

EXPERIMENTAL

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

Procedure: intracanal cryotherapy using needle irrigation and EndoVac system

Interventions

intracanal cryotherapy using needle irrigation and EndoVac system PROCEDURE

a cold saline will be used as final irrigant in two groups but with different irrigation systems.

intracanal cryotherapy using Endovac system; intracanal cryotherapy with needle irrigation

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Maryam rafique

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Maryam rafique, MDS

  DUHS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 21, 2021
• Study Start: July 15, 2019
• Primary Completion: February 18, 2021
• Study Completion: March 30, 2021
• Last Updated: September 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)