← Back to all trials
Completed
NCT07702877
Comparative Evaluation of Pediatric Rotary Files and Hand Files in Primary Molars
Conditions: Pulpectomy, Primary Teeth Indicated for Pulp Therapy, Mandibular Molar Teeth With Symptomatic Irreversible Pulpitis
Sex: All
Ages: 5 Years – 8 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Goa Dental College
Location: Goa Dental College and Hospital Bambolim Goa
Summary
The goal of this clinical trial is to evaluate and compare the efficacy of Kedo-Nano Plus rotary files, Kedo-S Square rotary files, and manual K-files for biomechanical preparation during pulpectomy of primary mandibular molars in children aged 5-8 years.
The main questions it aims to answer are:
* Does the use of Kedo-Nano Plus and Kedo-S Square rotary file systems result in better obturation quality compared with manual K-files during pulpectomy of primary mandibular molars?
* Does the use of Kedo-Nano Plus and Kedo-S Square rotary file systems reduce postoperative pain compared with manual K-files following pulpectomy?
Researchers will compare Kedo-Nano Plus rotary files, Kedo-S Square rotary files, and manual K-files to determine their effect on obturation quality and postoperative pain.
Participants will:
* Undergo clinical and radiographic evaluation of primary mandibular molars requiring pulpectomy.
* Be randomly allocated to one of three instrumentation groups: Kedo-Nano Plus rotary files, Kedo-S Square rotary files, or manual K-files.
* Receive pulpectomy treatment using the assigned instrumentation technique.
* Undergo radiographic assessment of obturation quality following treatment.
* Have postoperative pain assessed using the Wong-Baker Faces Pain Rating Scale at 6, 12, 24, and 48 hours after treatment.
Eligibility Criteria
Inclusion Criteria:
* Normal, healthy children between five and eight years of age
* Frankl's behavior rating: positive or definitely positive
* Primary mandibular molars diagnosed with irreversible pulpitis
* Intact crown structure suitable for rubber dam placement
* Intraoral periapical radiograph showing primary molars with at least two-thirds of each root remaining
Exclusion Criteria:
* Children with special healthcare needs or systemic medical conditions
* Frankl's behavior rating: negative or definitely negative
* Primary molars with unrestorable crown structure
* Teeth with severe mobility or pathological root resorption
* Children or parents who refused to participate in the study
Source: ClinicalTrials.gov (NCT07702877). StuddyBuddy aggregates publicly available trial information.