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Clinical Trials in India / NCT07500870
Active, not recruiting Not applicable

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

NCT07500870 · tracked via the Priya Life Science India tracker
Sponsor
All India Institute of Medical Sciences
Phase
Not applicable
Started
2025-12-04
Last updated
2026-03-30

Condition(s) studied

Post Endodontic PainPeriapical Healing

Investigational drug(s) / intervention(s)

rotary instrumentation kinematicsreciprocating instrumentation kinematics

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

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

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Systemically healthy (ASA (American Society of Anesthesiologists)-I,II )(22) participants between 18 - 60 years of age with diagnosis of pulp necrosis and AAP in single rooted lower anteriors and premolars Tooth will be diagnosed as AAP if it shows no clinical symptoms (no pain on percussion or palpation). 2. Radiographic evidence of periapical pathology with PAI score between 2 - 5. Exclusion Criteria: The patients with the following clinical and radiographic features will be excluded from the study: Clinical features: 1. Teeth with previous history of root canal treatment. 2. Teeth requiring severe prosthetic rehabilitation. 3. Pregnant or nursing mothers. 4. Periodontally compromised teeth. 5. Analgesic consumption for at least 12hrs before the visit. Radiographic features: 1. Immature/ Open apex 2. Non-patent apical foramen 3. Root resorption 4. External resorption 5. Calcified pulp canals.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
All India Institute of Medical Sciences Nagpur Maharashtra

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07500870 on ClinicalTrials.gov ↗ ← All trials in India