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Enrolling by Invitation

NCT Number: NCT06777381

Comparison of Post-Operative Pain Occurrence After Single Visit Root Canal Treatment

The goal of this clinical trial is to compare the post-operative pain occurrence after single visit root canal treatment using Two NiTi Rotary Files. The main question it aims to answer is:

• Does an instrument design and instrumentation technique could affect postoperative pain incidence and intensity? Researchers will use ProTaper Universal rotary system or M-Pro rotary system for root canal preparation and compared postoperative pain intensity.

Participants will receive single visit endodontic treatment using either ProTaper or MPro systems for root canal preparation.

Participants will record Pain intensity at 24 hours and 7 days post-operative. Analgesics will be prescribed for the patients in need.

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Key information

Conditions

Symptomatic Irreversible Pulpitis Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dental Clinic at Medical Research Centre of Excellence, National Research Centre

Cairo, Egypt

About this study

The main cause of patient fear is expecting pain during root canal treatment. It is considered a major concern for dentists as well. During root canal preparation, periapical extrusion of pulpal tissue remnants, microorganisms or dentin chips may be one of the causes of postoperative pain. Depending on the fact that, instrument design and instrumentation techniques have an impact on the amount of extruded debris apically, many studies proved the ability of some rotary systems to reduce debris extrusion, permitting to achieve less pain sensation.

Therefore, the present clinical study aims to compare the postoperative pain intensity in molars with symptomatic irreversible pulpitis after single endodontic treatment visit using a full-sequence rotary Ni-Ti system either ProTaper or MPro systems Eighty patients with symptomatic irreversible pulpitis in mandibular first molars will be assigned into two groups. In group A (n=40): root canal preparation will be performed in single visit using ProTaper Universal system and in group B (n=40): root canal preparation will be performed in single visit using M-Pro rotary system. Pain intensity will be recorded by the patient using Numerical Rating Scale (NRS) at 24 hours and 7 days postoperative. Analgesics will be prescribed for the patients in case of need.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient's diagnosis is symptomatic irreversible pulpitis in mandibular first molar.
  • Males and females patients in a good health.
  • Aged from 25 to 45 years old.
  • Pulp vitality is confirmed with cold pulp test and an electric pulp test.

Exclusion criteria

  • Pregnant females.
  • Patients complaining from pain in more than one molar on the same side.
  • Patients whose teeth react positively to percussion test.
  • Patients who receive analgesics 12 hours before the start of the root canal treatment.
  • Teeth having grade 2 or 3 mobility.
  • Presence of periapical radiolucency or teeth with extra oral or intraoral sinus tract or fistula.

Treatment and study plan

single visit root canal treatment using ProTaper Universal rotary system

Procedure

single visit endodontic treatment will be performed using ProTaper Universal rotary system for root canal preparation.

single visit root canal treatment using M-Pro rotary system

Procedure

single visit endodontic treatment will be performed using MPro rotary systems for root canal preparation.

Primary outcomes

  1. Record the intensity of postoperative pain after root canal treatment with ProTaper Universal and M-Pro endodontic rotary files.

    Time frame: 7 days

    Pain intensity will be recorded by the patient 24 hours and 7 days postoperatively. Pain assessment is evaluated using 10-point Numerical Rating Scale, where the endpoints are the extremes of no pain and worst pain. The severity of pain is assigned as follows: (0) equivalent to none/ (1) equivalent to slight pain / (2) equivalent to moderate pain and (3) equivalent to severe pain.

Sponsors and collaborators

Lead sponsor

National Research Centre, Egypt

Other

Registry information

Official study title

Comparison of Post-Operative Pain Occurrence After Single Visit Root Canal Treatment with Two NiTi Rotary Files - a Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 15, 2025
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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