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

NCT07500870 | Active Not Recruiting DMC

• 1 other identifier: IEC/Pharmac/2025/1730
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Asymptomatic Apical Periodontitis; Post endodontic pain; Periapical healing; Cryotherapy

Outcome Measures

Primary Outcomes (1)

• Post endodontic pain

  Assessment of Preoperative Pain Patients will be asked to record the preoperative pain on the Numerical Rating Scale-11 in accordance to the below mentioned standard criteria. 0 No Pain 1-3 Mild Pain 4-6 Moderate Pain 7-10 Severe Pain 10- Worst possible Pain

  12hours, 24hours, 48hours, 72hours and 7 days

Secondary Outcomes (1)

• Periapical healing

  6 months

Study Arms (2)

cryotherapy

EXPERIMENTAL

rotary instrumentation kinematics used in adjunct with cryotherapy

Procedure: rotary instrumentation kinematics; Procedure: reciprocating instrumentation kinematics

without cryotherapy

ACTIVE COMPARATOR

reciprocating instrumentation kinematics used in adjunct with cryotherapy

Procedure: rotary instrumentation kinematics; Procedure: reciprocating instrumentation kinematics

Interventions

rotary instrumentation kinematics PROCEDURE

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

cryotherapy; without cryotherapy

reciprocating instrumentation kinematics PROCEDURE

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

cryotherapy; without cryotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Radiographic evidence of periapical pathology with PAI score between 2 - 5.

You may not qualify if:

• The patients with the following clinical and radiographic features will be excluded from the study:
• Clinical features:
• Teeth with previous history of root canal treatment.
• Teeth requiring severe prosthetic rehabilitation.
• Pregnant or nursing mothers.
• Periodontally compromised teeth.
• Analgesic consumption for at least 12hrs before the visit.
• Radiographic features:
• Immature/ Open apex
• Non-patent apical foramen
• Root resorption
• External resorption
• Calcified pulp canals.

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

All India Institute of Medical Sciences

Nagpur, Maharashtra, 441108, India

Location

Study Design

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

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 30, 2026
• Study Start: December 4, 2025
• Primary Completion (Estimated): December 4, 2026
• Study Completion (Estimated): January 4, 2027
• Last Updated: March 30, 2026

Record last verified: 2025-12

Locations

IN (1)