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Manual and Rotatory Instrumentation Pulpectomy in Primary Mandibular Molars

NCT04636450 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-12-10

No results posted yet for this study

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.

Conditions

  • Dental Pulp Disease

Interventions

PROCEDURE

Rotatory technique pulpectomy

Primary mandibular molars treated with a rotatory technique pulpectomy and a K3 system or a Kedo-S system.

PROCEDURE

Manual pulpectomy

Primary mandibular molars treated with a manual pulpectomy and a K-file system or a Kedo-SH system.

Sponsors & Collaborators

  • Universidad Latinoamericana

    collaborator UNKNOWN

  • University Medical Center Groningen

    collaborator OTHER

  • Universidad de Guanajuato

    lead OTHER

Principal Investigators

  • Benjamín Franco Sánchez, DDS · Universidad Latinoamericana

  • Marianela Hernández-Baños, DDS · Universidad Latinoamericana

  • Jaime D Mondragon, MD, MSc · University Medical Center Groningen, Universidad de Guanajuato

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-08
Primary Completion
2021-12-15
Completion
2022-07-15

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04636450 on ClinicalTrials.gov