Effectiveness of Rotating System and Single File Reciprocating System in Temporal Molars

NCT04793477 | Recruiting

• 1 other identifier: UIC-ODP-LIMAS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Is an in vivo study to test the effectiveness of the reciprocating system Reciproc blue and the rotating system VDW.ROTATE in primary molars.

Conditions

Pulp Disease, Dental

Keywords

Pulpectomy; Rotary files; Reciprocating files

Outcome Measures

Primary Outcomes (1)

• Evaluate instrumentation time with K, Rotate and Reciproc Blue files.

  Once the instrumentation and irrigation is finished, the operator will record the time elapsed from the beginning to the end of the instrumentation with the disinfection of the appropriate irrigant. The operator will record the minutes and seconds evaluated with an analog stopwatch.

  Immediately after instrumentation. From the beginning to the end of the instrumentation with the files

Secondary Outcomes (5)

• Evaluate the postoperative pain with the K files, the Rotate and the Reciproc Blue.

  at 6, 12, 24, 48, 72 hours and a week later

• Evaluate the quality of the filling of the duct without the need of any auxiliary elements with the files K, the Rotate and the Reciproc Blue.

  Immediately after the procedure

• Evaluate the child's behavior comparing to some previous restorative treatment with K, Rotate and Reciproc Blue files.

  Immediately after the procedure

• Evaluate the child's heart rate during instrumentation with K, Rotate and Reciproc Blue files.

  During one week. Evaluation 3 minutes before topical anesthesia, topical anesthesia, local anesthesia, rubber dam, caries removal and coronal pulp tissue elimination, duct instrumentation, rubber dam removed.

• Evaluate the operator ease during instrumentation with K, Rotate and Reciproc Blue files.

  Immediately after the procedure

Study Arms (3)

K files (Dentsply Caulk, Milfors, DE, USA)

EXPERIMENTAL

Instrumentation with manual files shall be performed with balanced forces (Roane) technique consist of placing the instrument as apically as it can go and then turning it clockwise (less than 180º). This is followed by a counterclockwise rotation (of at least 120º) with slight apical pressure. This is repeated until the desired working length is obtained.

Device: instrumentation technique in pulpectomies

VDW.ROTATE (VDW, Munich, Germany).

EXPERIMENTAL

Instrumentation with VDW.ROTATE files shall be performed with a glide path to WL using VDW.ROTATETM 15.04 until reaching working length (1.3cNm and 300-400 rpm), the next instrument in the sequence is VDW.ROTATETM 20.05 until reaching working length (2.1cNm and 300-400rpm). and finally instrument with VDW.ROTATETM 25.04 (2.3cNm and 300-400rpm)

Device: instrumentation technique in pulpectomies

Reciproc® blue (RCP, VDW, Munich, Germany)

EXPERIMENTAL

Instrumentation with Reciproc blue files shall be performed with only one file and move it in a pecking motion (the amplitude will not exceed 3mm). All the instruments shall be cleaned after 3 pecks.

Device: instrumentation technique in pulpectomies

Interventions

instrumentation technique in pulpectomies DEVICE

comparison of three file systems for pulpectomies in primary molars

K files (Dentsply Caulk, Milfors, DE, USA); Reciproc® blue (RCP, VDW, Munich, Germany); VDW.ROTATE (VDW, Munich, Germany).

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Vital or non-vital temporary lower second molars.
• Radiographic absence of external or internal pathological reabsorption.
• Absence of interadicular radioluscience and/or periapical lesion.
• Temporary teeth with at least 2/3 of the root intact or a minimum root length of 8mm.
• Remaining dental structure sufficient for the subsequent placement of a stainless steel crown.
• Children who have already undergone some previous restorative treatment in the Department of Pediatric Dentistry.

You may not qualify if:

• Molars that have less than 2/3 radicular lenght.
• Have taken analgesics or anti-inflammatories in the last 12 hours.
• Very uncooperative patients, who require some type of anxiety to be treated.
• Patients with systemic diseases.
• Patients with special needs.

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

RECRUITING

MeSH Terms

Conditions

Dental Pulp Diseases

Interventions

Pulpectomy

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Central Study Contacts

Francisco Guinot Jimeno, DDS, MsC

CONTACT

935042000; fguinot@uic.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of the department of pediatric dentistry

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: March 11, 2021
• Study Start: May 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2024
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)