Effectiveness of Cryotherapy on Endodontic Pain

NCT ID: NCT06785753

Last Updated: 2025-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-07

Study Completion Date

2025-05-08

Brief Summary

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This is a randomized , prospective , control trial to assess the effectiveness of intracanal cryotherapy on post operative pain after root canal treatment in patients with symptomatic apical periodontitis

Detailed Description

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Diagnostic procedures to include patients history taking , clinical and radiographic with all findings being recorded in patients .

patients diagnosed with symptomatic irreversible pulpitis with symptomatic apical periodontitis.

patients will be asked to rate their pre treatment pain on visual analogue scale from 0-10

patients with pain score \<8 will be considered

Anesthesia and isolation : after administration of local anesthesia , rubber dam application will be done

Acess cavity : acess will be gained with round bur using air turbune handpiece with copious water cooling

Working length : a size 10k file will be inserted into the canal to determine the working length with the help of radiograph

Cleaning and shaping : Extirpation of pulp will be done followed by canal preparation with manual and endodontic motor using naocl and EDTA .

final irrigation will be performed using 17% EDTA and 5.25% NaOCl

Patients will be divided into 2 group in control group : final irrigation will be done using 5ml of saline at room temperature in cold group : final irrigation will be done using 5ml of cold saline at 2.5°C

the solution will be stored in the refrigerator until use irrigation will be performed for 5 min in both groups using 27 G beveled needle tip inserted 2mm short of WL.

Obturation ; In both groups , canals will be dried with paper points and obturated using gutta percha cones with zinc oxide eugenol sealer

Restoration : acces cavity will be restroed with direct composite restoration or high viscosity glass ionomer cement

each patient will be given instruction to acess the post operative pain .

Conditions

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Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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normal saline group

In control group , canals will be irrigated with 5ml of normal saline at room temperature

Group Type EXPERIMENTAL

Irrigation Solution

Intervention Type DRUG

normal saline will be used as irrigation solution

cryotherapy (cold saline group)

in cold saline group , canals will be irrigated with 5 ml of cold saline at a temperature of 2.5° C

Group Type EXPERIMENTAL

Irrigation Solution

Intervention Type DRUG

normal saline will be used as irrigation solution

Interventions

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Irrigation Solution

normal saline will be used as irrigation solution

Intervention Type DRUG

Other Intervention Names

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normal saline irrigant

Eligibility Criteria

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Inclusion Criteria

* patients with symptomatic irreversible pulpitis and symptomatic apical periodontitis
* maxillary or mandibular single rooted teeth
* systemically healthy patients
* patients having pain score \< 8

Exclusion Criteria

* patients on preoperative analgesics or antibiotics within past 12 hours
* teeth with calcified canals and previously treated teeth
* tooth with immature apices or resorption
* patients allergic to local anesthesia
* pregnant or lactating mothers
* patients who are immunocompromised .
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Armed Forces Institute of Dentistry, Pakistan

OTHER

Sponsor Role lead

Responsible Party

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Hira Amjad

Dr. Hira Amjad , Principal investigator and Resident Operative Dentistry and Endodontics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hira Amjad, BDS

Role: PRINCIPAL_INVESTIGATOR

Armed Forces Institude Of Dentistry

Locations

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Armed Forces Institute of Dentistry

Rawalpindi, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Hira Amjad, BDS

Role: CONTACT

03345294071

Kanza Zafar, BDS

Role: CONTACT

03337808809

Facility Contacts

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Hira Amjad, BDS

Role: primary

03345294071

Other Identifiers

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Cryotherapy

Identifier Type: -

Identifier Source: org_study_id

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