Postoperative Pain After Using a Minimally Invasive Reciprocating Single-file System in Mandibular Molars With Symptomatic Irreversible Pulpitis
1 other identifier
interventional
56
0 countries
N/A
Brief Summary
The aim of the present study is to assess the incidence and severity of postoperative pain after root canal preparation of mandibular molars with symptomatic irreversible pulpitis using a minimally invasive reciprocating single-file system in comparison to Wave One Gold.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2026
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2026
CompletedFirst Posted
Study publicly available on registry
July 22, 2026
CompletedStudy Start
First participant enrolled
July 31, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2026
July 22, 2026
July 1, 2026
3 months
July 13, 2026
July 17, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Pain assessment
assessment of pain on Visual Analog Scale (VAS) scoring system
after (6) hours, (12) hours, (24) hours, (48) and (72) hours of the procedure
Study Arms (2)
Reciprocating rotary single-file system
ACTIVE COMPARATORroot canal preparation by one reciprocating rotary single-file system
Wave One Gold rotary file system
ACTIVE COMPARATORroot canal preparation by Wave One Gold rotary file system
Interventions
One glider will be used then (25/6) will be used to prepare narrow and curved canals as mesials in lower molars, and the large file (45/4) will be used for large canals. Three in-and-out motions were applied with motions until attaining full working length
Wave One Gold glider will be used then primary (25\\7) to prepare narrow and curved canals as mesials in lower molars, and the file (45/5) will be used for large canals. Three in-and-out motions will be applied with motions until attaining full working length
Eligibility Criteria
You may qualify if:
- Adult patients who have vital mandibular molar teeth with irreversible pulpitis without apical periodontitis.
- Medically free patients.
You may not qualify if:
- Pregnancy or lactation
- Patients with para functional habits.
- Teeth with non-vital pulps and periapical lesions.
- The presence of swelling or a fistulous tract.
- Any periodontal pockets with a depth more than 5 mm.
- Previous endodontic fillings.
- Patients with a history of any systemic diseases.
- Severely curved canals and calcified ones.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Minia Universitylead
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
July 13, 2026
First Posted
July 22, 2026
Study Start
July 31, 2026
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
October 31, 2026
Last Updated
July 22, 2026
Record last verified: 2026-07