Single Rotary File System vs Manual Instrumentation for Pulpectomy in Primary Molars

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized clinical trial, children aged 4–6 with irreversible pulpitis in restorable mandibular second primary molars will be assigned to either single rotary file instrumentation or conventional manual instrumentation for pulpectomy. The study aims to observe differences in child behavior during the procedure, as shorter instrumentation time with rotary systems may influence anxiety and cooperation. The trial uses standard criteria to ensure teeth are restorable, with radiographs confirming absence of significant resorption or radiolucencies, and excludes uncooperative or medically complex patients. Outcome measures focus on behavior during treatment, with follow-up visits to monitor success and adverse events. The research reflects the pediatric dentistry goal of making pulpectomy quicker and more efficient while preserving primary teeth.”,

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients:

  • Aged 4-6years, Medically free and Cooperative.
* Teeth:

  * Restorable mandibular second primary molars with clinical signs or symptoms of irreversible pulpitis.

Pre-operative Radiographic criteria:

* Absence of internal or external root resorption.
* Absence of periapical or inter-radicular radiolucencies.

Exclusion Criteria:

* Patients:

  * Uncooperative children.
  * Children with systemic disease.
  * Physical or mental disabilities.
  * Refusal of participation.
  * Unable to attend follow- up visits.
  * Refusal to sign the informed consent.

Teeth:

* Previously accessed teeth.
* Mobile mandibular primary molars.
* Pain on percussion.
* Swelling in the vestibule or on palpation.

Where it's running

• Faculty of Dentistry, Cairo University
  Cairo, Egypt Recruiting

Study contacts

• Study coordinator: amira M ibrahim, master
• Email: amira-mohamed@dentistry.cu.edu.eg
• Phone: +201002585750

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Impact of a 1-file rotary system on debris extrusion during root canal treatment

  This study tests whether using a single-file AF One system during root canal shaping reduces postoperative discomfort in teeth with irreversible pulpitis and mature roots.

  Recruiting Minia University · Minya, Minya Governorate · NCT07808684

• Complete pulpotomy versus root canal for irreversible pulpitis in adults with Type 2 diabetes

  This will test whether complete pulpotomy or root canal treatment better preserves symptom-free, functional mature back teeth with irreversible pulpitis in adults who have Type 2 diabetes.

  Recruiting Postgraduate Institute of Dental Sciences Rohtak · Rohtak, Haryana · NCT07163975

• Evaluating the effectiveness of pulpotomy for treating deep caries in permanent teeth

  This study is testing how well pulpotomy treatments work for adults with deep tooth decay to see if they can keep their teeth healthy and pain-free.

  Recruiting Universidad Rey Juan Carlos · Alcorcón, Madrid · NCT06918639

• Pulpotomy vs Pulpectomy for painful baby teeth in children

  This study tests whether pulpotomy can work as well as pulpectomy for treating painful, living primary molars in kids aged 4–9.

  Recruiting Qatar University · Irbid and 1 other locations · NCT06904781

• Evaluating the success of vital pulp therapy methods for dental pulp exposure

  This study is testing different ways to treat exposed dental pulp to see which methods work best for adults with teeth that can be saved.

  Recruiting Semmelweis University · Budapest · NCT06844448

• Measuring bite force to understand dental pain

  This study is testing how strong people's bite is when they have dental pain to see if it can help improve pain management and reduce the need for opioids during dental treatments.

  Recruiting Rutgers, The State University of New Jersey · Newark, New Jersey · NCT06843525

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.