Assessment of pain after single visit root canal treatment

Completed

• Conditions: Pulpitis,

• Registration Number: CTRI/2023/05/052543
• Lead Sponsor: Disha Dhananjay Raysad

Brief Summary

·         **BACKGROUND OF STUDY:**

·         Single visit endodontic treatment has gained preference over multiple visit endodontic due to advantages such as decreased number of operative procedures and no risk of inter-appointment leakage of the temporary restoration, and its economical.

·         There is an exponential growth in field of instrumentation to treat complexity of canal, great amount of research is been undertaken regarding the materials of file system and their manufacturing procedures.

·         Neolix neoniti and E3 Azure file system both are extremely flexible and resistant to breakage. However, they are made from different technology and have different cross sections. Both of these instruments are responsible in very big way for causing extrusion of debris which is normally seen phenomenon with any instrument used with any technique

·         So, this kind of extrusion of debris  which is one of the main causative factors for post operative pain that instrument which cause minimal extrusion becomes prudent as it causes less pain

·         Invitro study done on Neolix neoniti claimed to have decreased apical debris extrusion Whereas in vivo study done on E3 Azure with and without maintaining apical patency did not show significant post operative pain thus it leads to aim of study

 Â·         **PURPOSE:**

·         To evaluate and compare incidence and intensity of the post - operative pain after single visit endodontic treatment using Neolix neoniti and E3 Azure file systems.

·         To evaluate and compare the time required for instrumentation of canals in both groups.

·         To evaluate and compare the association of variables (age and sex) between groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-15
• Study Completion: 2023-11-21
• Last Update Posted: 2024-04-21

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• INCLUSION CRITERIA 1.Patients requiring root canal treatment of maxillary premolar teeth with two root canals, diagnosed clinically as asymptomatic irreversible pulpitis using pulp sensitivity tests.
• 2.Patients ranging in the age group of 18-50 years.
• 3.Patients with non-contributory medical history.
• 4.Teeth with no pre-operative pain 5.Teeth with adequate coronal structure to ascertain proper isolation.

Exclusion Criteria

• EXCLUSION CRITERIA:.
• PATIENT SPECIFIC: 1.Patients who refuse to consent for the procedure. 2.Patients with any systemic diseases, pregnancy or immuno.
• compromised conditions. 3.Patients on any antibiotic therapy in the past 3 months 4.Patients on any analgesic drugs in the past 7 days 5.Patients allergic to lignocaine in 1:80,000 concentration adrenaline 6.Patients allergic to Ibuprofen 7.Patients requiring root canal treatment of two or more teeth ipsilaterally (since the pain caused by any of these teeth can result in false positive reading) SPECIFIC TO DIAGNOSIS: 1.Teeth with acute apical periodontitis 2.Teeth with acute periapical abscess 3.Teeth with periapical radiolucency of diameter greater than0.5 cm (5 mm) 4.Teeth with an inflammatory exudate draining through the canal. 5.Necrotic painful teeth with absence of sinus tract for drainage 6.Re-treatment cases 7.Dilacerated teeth 8.Teeth with aggressive periodontitis or grade III mobility TOOTH SPECIFIC: 1.Teeth with calcified canals, immature apex and internal and external resorption. 2.Two root canals ending with a single apical foramen. 3.Severe labially or lingually malpositioned teeth in which obtaining straight-line access is difficult. 4.If a #10 K-file is very resistant to movement or if a #20 K-file easily goes to length, then teeth with such canals will be excluded (apical gauging).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate and compare the incidence and intensity of post-operative pain after single visit endodontic treatment using Neolix Neoniti and E3 Azure file system at 6, 24, 48 and 72 hours using Visual Analogue Scale	6, 24, 48 and 72 hours

Secondary Outcome Measures

Name	Time	Method
To evaluate and compare the association of variables (age and sex) between groups

Trial Locations

Locations (1)

KAHER KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus,Nehru Nagar; 🇮🇳 Belgaum, KARNATAKA, India

KAHER KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus,Nehru Nagar

🇮🇳Belgaum, KARNATAKA, India

Disha Dhananjay Raysad

Principal investigator

09535428250

dhananjaydishadr@gmail.com