Evaluation of Post Obturation Pain Associated With Calcium Hydroxide-based Root Canal Sealers and Resin-based Root Canal Sealer: a Single Visit Root Canal Treatment

NCT06798467 | Completed

• 1 other identifier: JSMU/IRB/2024/971
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the post obturation pain associated with calcium hydroxide-based root canal sealer and resin-based root canal sealer after single visit root canal treatment following endodontic treatment by means of Visual Analog Scale. Methods: This study was designed as single blind, randomized control trial. Sixty patients with irreversible pulpitis requiring endodontic canal treatment were recruited by probability random sampling into two groups based on root canal sealer used during endodontic treatment: calcium hydroxide-based root canal sealer and resin-based root canal sealer . The post-operative pain of patients was recorded via a telephone call at 6 hours, 24 hours, and at 48hours on the visual analogue scale (VAS).

Conditions

Root Canal Sealers; Post Operative Pain; Irreversible Pulpitis

Keywords

root canal sealers; post operative pain; symptomatic periapical periodontitis; calcium hydroxide sealer; resin-based root canal sealer; visual analogue scale

Outcome Measures

Primary Outcomes (1)

• Evaluation of post obturation pain associated with calcium hydroxide-based root canal sealers and resin-based root canal sealer: a single visit root canal treatment.

  Introduction: Modern endodontics offers advancements in technologies, procedures and materials. Post-obturation pain is defined as pain of any degree that occurs after initiation of root canal treatment and its occurrence was noted to vary between 3 and 58%. The objective is to evaluate the post obturation pain associated with calcium hydroxide-based root canal sealer and resin-based root canal sealer after single visit root canal treatment following endodontic treatment by means of Visual Analog Scale. Methods: This study was designed as single blind, randomized control trial .Sixty patients with irreversible pulpitis requiring endodontic canal treatment were recruited by probability random sampling into two groups based on irrigation protocols used during endodontic treatment: calcium hydroxide-based rootand resin-based root canal sealer . The post-operative pain of patients was recorded via a telephone call at 6 hours, 24 hours, and at 48 hours on the visual analogue scale (VAS).

  6 hours, 24 hours and 48 hours

Study Arms (2)

post obturation pain

ACTIVE COMPARATOR

Unpleasant sensation of any degree of pain after root canal treatment.

Other: Endodontic sealer

endodontic sealer

ACTIVE COMPARATOR

endodontic sealer is a material used in root canal therapy to fill the microscopic spaces between the root canal filling material (typically gutta-percha) and the walls of the root canal. Its primary function is to create a tight seal that prevents the ingress of bacteria and fluids into the root canal system, helping to prevent reinfection and promoting the healing of periapical tissues. Endodontic sealers also help to ensure that the root canal filling reaches all parts of the canal, especially in complex or irregularly shaped anatomies.

Other: post obturation pain

Interventions

Endodontic sealer OTHER

endodontic sealer is a material used in root canal therapy to fill the microscopic spaces between the root canal filling material (typically gutta-percha) and the walls of the root canal. Its primary function is to create a tight seal that prevents the ingress of bacteria and fluids into the root canal system, helping to prevent reinfection and promoting the healing of periapical tissues. Endodontic sealers also help to ensure that the root canal filling reaches all parts of the canal, especially in complex or irregularly shaped anatomies.

post obturation pain

post obturation pain OTHER

Unpleasant sensation of any degree of pain after root canal treatment.

endodontic sealer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting with signs and symptoms of irreversible pulpitis in maxillary or mandibular teeth
• ≥18 years of age.

You may not qualify if:

• Patients with any systemic diseases
• Retreatment cases
• Teeth with calcified canals.
• Medically compromised patient (with immunosuppressive/ systemic diseases, patient on medication)
• Patients on analgesics or sedative medication prior to root canal therapy.
• Patients in whom single visit endodontic treatment will not be possible

Sponsors & Collaborators

• Jinnah Sindh Medical University: lead

Study Sites (1)

Sindh Institute of Oral Health Sciences Jinnah Sindh Medical University Karachi

Karcahi, Sindh, 75510, Pakistan

Location

Related Publications (1)

• Khatri S, Parvez S, Agarwal MK, Goyal D, Binawra KK, Jain A, et al. Comparative Evaluation of Effect of Resinbased, Calcium Hydroxide-Based and Bioceramic-Based Root Canal Sealers on Postoperative Pain. List of Articles Pages No.2022;11(1) :54-61

  BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BDS, FCPS-II TRAINEE

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 29, 2025
• Study Start: October 1, 2024
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

PA (1)