Evaluation of Post-operative pain using four different types of Root Canal Sealers.

Phase 4

Recruiting

• Conditions: Acute apical periodontitis of pulpal origin, (2) ICD-10 Condition: K045||Chronic apical periodontitis, (3) ICD-10 Condition: K040||Pulpitis,

• Registration Number: CTRI/2023/04/051599
• Lead Sponsor: All India Institute of Medical Sciences, Jodhpur

Brief Summary

Postoperative pain is an unwanted yet unfortunately a common sensation after endodontic treatment. The incidence of postoperative pain has been reported to range from 3% to 58%. There is no single factor affecting pain after root canal treatment and it may be due to mechanical, chemical and/or microbial injury to the pulp or peri-radicular tissues, further irrigating solutions, medications and sealers can evoke pain by irritating the periradicular tissues. Any intracanal sealer that has a reduced the risk of extrusion into periapical tissues would help the patient and the clinician because such a root canal sealer could decrease postoperative discomfort. Thus, the present clinical trial aims to comparatively evaluate four different root canal sealers (Tubliseal, AH Plus, BioRoot RCS and Nishika Canal Sealer BG) on causing post operative pain in patients with symptomatic irreversible pulpitis or apical periodontitis following root canal therapy. A total of 100 patients who meet the inclusion criteria will be enrolled for the clinical trial and four different sealers will be used belonging to four different compositions. These will be manipulated as per the manufacturer’s instructions, carried into the root canal coated on a gutta percha point and applied onto the root canal walls in an anticlockwise motion. This application shall be repeated three times.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-06
• Last Update Posted: 2024-03-28

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients between the age group of 18 years to 65 years 2.
• Single rooted teeth with single apical exit.
• Patients with no signs of immature apex or previously initiated RCT.
• Patients with symptomatic irreversible pulpitis or apical periodontitis.

Exclusion Criteria

• Patients who had taken analgesic or anti-inflammatory drugs within the last 12 hours of root canal obturation.
• Pregnancy or lactation 3.
• Teeth with calcified canals 4.
• Teeth with periodontal diseases 5.
• Teeth with root resorption 6.
• Teeth with immature/open apex 7.
• Previously treated or initiated tooth.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To comparatively evaluate the incidence of post-operative pain using four different classes of sealers (Tubliseal, AH Plus, BioRoot RCS and Nishika Canal Sealer BG) following root canal therapy.	Post-operatively 24 hrs, 72 hrs, 7 days

Secondary Outcome Measures

Name	Time	Method
To comparatively evaluate the ability of four different classes of sealers for greater flow and to corelate incidence of apical extrusion of sealer with postoperative pain following root canal therapy.	Post-operatively 24 hrs, 72 hrs, 7 days
To comparatively evaluate the radio-opacity of the obturated root canal with four different classes of sealers.	Post-operatively

Trial Locations

Locations (1)

All India Institute of Medical Sciences, Jodhpur; 🇮🇳 Jodhpur, RAJASTHAN, India

All India Institute of Medical Sciences, Jodhpur

🇮🇳Jodhpur, RAJASTHAN, India

DR PRAVIN KUMAR

Principal investigator

9818402220

kumarpr@aiimsjodhpur.edu.in