MedTrace Logo

Clinical and Biochemical Effects Of Cryotherapy Protocols On Mandibular Premolars With Symptomatic Apical Periodontitis

NCT07138365 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-02-11

No results posted yet for this study

Summary

Pain is the major reason for patients' visits to dental clinics.Medications have side effects. Treatments including cryotherapy have been suggested to prevent these side effects.This study will compare the effect of oral and intraradicular cryotherapy on the level of substance p ,post operative pain and analgesic intake in mandibular premolars with symptomatic apical periodontitis.

Thirty patients with symptomatic apical periodontitis will be randomly distributed into three groups: oral,intraradicular cryotherapy and control group (n = 10). In the oral cryotherapy group application of (a cold pack of ice gel enveloped by a sealed plastic cover) will be performed for 30 minutes following the completion of canal preparation.Getting glide path by inserting K-file #10. coronal flaring will be done .The first apical fluid samples for all groups will be obtained at this step. Intra-radicular cryotherapy will be performed where normal root canal treatment will be done. Then a final flush will be done with 20 mL of cold saline 2.5°C for 10 minutes.

For the control group,no application of cryotherapy will be done.Second samples will be taken after mechanical preparation for intraradicular and control ,and after 30minutes of cold application for the cryotherapy group.Levels of substance p will be measured using the ELISA test.The patients will be asked to fill out the VAS questionnaire at 6, 24, 48 and 72 h.and analgesic intake

Conditions

Interventions

PROCEDURE

oral Cryotherapy

custom made plastic pack measuring 2.5 X5 cm containing ice gel will be placed intraorally in the mouth on the vestibular surface of the treated tooth.

PROCEDURE

Intra radicular Cryotherapy

Final flush was done with cold (2-4 oC) Saline for 10 mins.

PROCEDURE

cold irrigation

irrigation with cold (2-4 oC) 2.5% NaOCl and Final flush was done with cold (2-4 oC) Saline for 10 mins.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Maram F Obeid, Professor · Faculty of Dentistry,Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2025-06-01
Completion
2025-06-01

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07138365 on ClinicalTrials.gov