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Comparative Evaluation of Endodontic Instrumentation Kinematics and Cryotherapy on Post-endodontic Pain and Periapical Healing

NCT07500870 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-30

No results posted yet for this study

Summary

TITLE : Comparative evaluation of two different endodontic instrumentation kinematics and cryotherapy on post endodontic pain and periapical healing in teeth with asymptomatic apical periodontitis - A double blind, prospective randomized clinical trial Background : Root canal treatment is done to save teeth that are infected or damaged. Although this procedure relieves pain in the long term, many patients experience discomfort or pain after treatment, known as post-endodontic pain (PEP). The way dentists clean the root canals and the methods used to reduce inflammation may influence how much pain patients feel and how well the bone around the tooth heals. This study will compare two modern ways of cleaning root canals using special nickel-titanium files. The first method uses a rotary system, where the files continuously rotate inside the canal. The second method uses a reciprocating system, where the files move back and forth. Both systems are commonly used in dentistry, but it is still not clear which one leads to less pain and better healing. The study will also test the benefit of cryotherapy, which means rinsing the canal with very cold saline at the end of the cleaning. Cold therapy reduces blood flow and nerve activity, helping to control pain and swelling without the side effects of medicines.

Methodology: Sixty patients with asymptomatic apical will be included. They will be randomly assigned into four groups: Group1:Rotary system with cryotherapy, Group 2:Rotary system without cryotherapy, Group 3: Reciprocating system with cryotherapy, Group 4 : Reciprocating system without cryotherapy.Patients will record their pain on a simple scale at different times after treatment. Healing of the infection will be checked with X-rays after six months.

OBJECTIVES:

Primary Objective:

To compare the post endodontic pain following instrumentation with a rotary vs reciprocating kinematic instrumentation system at different irrigant temperature using NRS-11 scale.

Secondary Objective:

To assess the periapical healing following endodontic treatment with or without adjunctive use of cryotherapy assessed with periapical healing index .

The results of this study will help dentists understand whether cryotherapy and the choice of instrumentation system can reduce patient discomfort and improve treatment success. This may lead to better patient care and less need for pain medications after root canal treatment.

Conditions

  • Post Endodontic Pain
  • Periapical Healing

Interventions

PROCEDURE

rotary instrumentation kinematics

biomechanical preparation of root canal using rotary instrumentation kinematics with and without adjunctive use of cryotherapy

PROCEDURE

reciprocating instrumentation kinematics

biomechanical preparation of root canal using rotary instrumentation kinematics with and without adjunctive use of cryotherapy

Sponsors & Collaborators

  • All India Institute of Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-04
Primary Completion
2026-12-04
Completion
2027-01-04

Countries

  • India

Study Locations

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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 NCT07500870 on ClinicalTrials.gov