Manual and Rotatory Instrumentation Pulpectomy in Primary Mandibular Molars (NCT04636450) | Clinical Trial Compass
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Manual and Rotatory Instrumentation Pulpectomy in Primary Mandibular Molars
Mexico100 participantsStarted 2020-12-08
Plain-language summary
In this study, the aim is to compare manual and rotatory pulpectomy techniques on 100 primary mandibular molars on children between the ages of 4 and 8 years. The plan is to conduct a randomized controlled trial with a 1:1 ratio for group allocation at a teaching university pediatric dentistry clinic between January 2021 and December 2021. Two manual systems, as well as two rotary systems, will be randomly assigned. The adult manual system used will be K-file and the adult rotary system will be K3. The pediatric manual system used in this study will be Kedo-SH, while the pediatric rotary system will be Kedo-S. The observed outcome measures in this study are the following: 1) instrumentation and filling time; 2) filling quality by radiographic evaluation; 3) postoperative pain levels using the visual analog scale at 12 and 24 hours; and 4) frequency of complications (e.g. fistulas, thinning of the mesiodistal walls, periapical or furcation radiolucency) after a 3-, 6-, 9-, and 12-month follow-up.
Who can participate
Age range4 Years – 8 Years
SexALL
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Inclusion criteria
✓. Patients between 4 to 8 years old.
✓. Both genders.
✓. Patients with an indication for pulpectomy for mandibular molars, based on the of Kuo and colleagues criteria (2006).
✓. Patients requiring pulpectomy in posterior teeth.
✓. Adequate dental structure of the crown.
✓. Patients with a remnant structure of at least two-thirds of the root.
✓. Patients with a medical file at the Pediatric Dentistry Clinic, Universidad Latinoamericana, Campus Valle.
✓. Patients with signed informed consent.
Exclusion criteria
✕. Patients requiring pulpotomy, extraction, or pulp regeneration therapy.