A clinical study on post operative pain after single sitting root canal treatment.

Not yet recruiting

• Conditions: Pulpitis,

• Registration Number: CTRI/2023/07/054831
• Lead Sponsor: MGM Dental College and Hospital

Brief Summary

**Title:** Comparative evaluation of post-operative pain following single visit endodontics using of two NiTi file systems based on different kinematics: A Randomized clinical study.

Dental pain is most commonly induced by caries disease which is caused by specific types of bacteria. The caries disease elicits subsequent inflammation which might necessitate endodontic treatment the primary goal of endodontic treatment is to eliminate disease and manage the symptoms of the patient. Postoperative pain is an unpleasant sensory experience in patients undergoing endodontic treatment and has been reported in 25-40% of all endodontic patients. This pain is caused by the release of inflammatory mediators in the periradicular region due to increased vascular permeability and consequent oedema, which lead to the compression of nerve fibers in that region.

Extrusion of infected dentin into the periapical tissue has been suggested as a major source of pain after endodontic treatment**.** Clinically, a

relationship exists between the presence of inflammatory mediators and the extrusion of debris, which depends on the preparation of the root

canal system.

Several clinical trials have compared the effect of reciprocating and rotation kinematics on postoperative pain and reported conflicting results, which might be attributed to the use of different instrumentation systems with different mechanical properties and designs**.** Therefore, further clinical data are necessary to elucidate the effect of endodontic instruments on postoperative pain.

This study is a prospective, single-centre, double blind randomized clinical study with a concurrent parallel study design. Consecutive, Consenting sampling. Comparison will be done on of postoperative pain following single visit endodontics after the use of two NiTi file systems based on different kinematics: 80 patients will be selected on the basis of inclusion and exclusion criteria. Which further divide into 40 participants each. The patient will be allotted to one of the instrumentation techniques by random allocation using Graph pad by domatics software. Concealment allocation will be carried out by using sequentially numbered sealed opaque envelopes by a neutral observer. After randomization, allotted group will be written on a paper and kept in an opaque sealed envelope

**Group 1:** Root canals will be prepared by TruNatomy rotary system.

**Group 2:** Root canals will be prepared by WaveOne Gold reciprocating system. Cleaning and shaping of the canal will ne by done in which.

The patient will be given post-operative instructions and will be recalled at the following intervals: 6 hours, 24 hours and 7 days, and evaluated

for pain scale. Pain assessment will be done with the help of visual analogue scale (VAS). Participants will be asked to place a single mark on line to indicate current level of the pain. Using a ruler, distance was measured in mm from “no pain†anchor to mark on visual analogue scale line.

Although all instrumentation techniques produce apical extrusion of debris, the difference lies in the ability of some techniques to extrude less debris than others.

The rationale of this study is to evaluate the of post-operative pain in patients with chronic irreversible pulpitis following single-visit endodontics using two different nickel-titanium file systems based on different kinematics. This study would determine whether the use of the instruments would influence the occurrence of post-operative pain

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-09
• Last Update Posted: 2023-03-07

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 1.All vital single-rooted teeth with irreversible pulpitis, whether associated with or without apical periodontitis, and mild to moderate pain (VAS value 5-74mm) indicated root canal treatment.2.Maxillary and mandibular premolars with single root and single canal.3.Patients with single rooted permanent teeth with periapical radiolucency less than 1.5 mm as determined by an intraoral periapical (IOPA) radiograph.
• 4.Teeth with fully developed apex and straight canals with minimal curvature (0 to 10 degrees) 5.Teeth with healthy periodontium with periodontal probing depth 3.

Exclusion Criteria

• 1.Pregnant women and lactating mothers.
• Patients with acute dentoalveolar abscess or cellulitis.
• Patients presenting with severe pain (75-100mm).
• Patients who have taken antibiotics and analgesics and corticosteroid in the past month.
• 5.Patients with known immunocompromised conditions (e.g., AIDS) 6.Patients who are known diabetic.
• 7.Patients with non-vital teeth and intraoral and extraoral sinus tract 8.Patients with radiographic evidence of radiolucency of more than 1.5 mm 9.
• open apex, root resorption.
• presence of root caries and multirooted teeth 10.
• Teeth with aggressive periodontitis and grade III mobility, periodontal probing depth >3mm.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
compare the of post-operative pain in	The assessment of the post-operative pain will be conducted at intervals of 6 hours, 24 hours, and 7 days after the initial visit.
two different rotary instrument systems. For each patient, the	The assessment of the post-operative pain will be conducted at intervals of 6 hours, 24 hours, and 7 days after the initial visit.
single-visit endodontics where canal instrumentation will be done using	The assessment of the post-operative pain will be conducted at intervals of 6 hours, 24 hours, and 7 days after the initial visit.
preoperative and post-operative pain levels will be recorded by using a	The assessment of the post-operative pain will be conducted at intervals of 6 hours, 24 hours, and 7 days after the initial visit.
visual analogue scale (VAS)	The assessment of the post-operative pain will be conducted at intervals of 6 hours, 24 hours, and 7 days after the initial visit.

Trial Locations

Locations (1)

MGM Dental College and Hospital; 🇮🇳 Raigarh, MAHARASHTRA, India

MGM Dental College and Hospital

🇮🇳Raigarh, MAHARASHTRA, India

Dr Rutuja Rajput

Principal investigator

8169752300

ruturajput30@gmail.com