Instrumentation Time Efficiency and Histologically the Debriding Efficacy.

NCT03770754 | Unknown DMC

• 1 other identifier: Intrumentation time efficiency
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 4

Brief Summary

The goal of pulp therapy in the primary dentition is to retain the primary tooth as a fully functional part of the dentition, allowing at the same time for mastication, phonation, swallowing, and the preservation of the space required for the eruption of the permanent tooth. The premature loss of primary teeth may cause changes in the chronology and sequence of eruption of permanent teeth. Maintenance of primary teeth until physiological exfoliation prevents deleterious habits in children. The primary objectives of cleaning and shaping the root canal system are removing soft and hard tissue containing bacteria, providing a path for irrigants to the apical third, supplying space for medicaments and subsequent obturation, retaining the integrity of radicular structure. The choice between pulpotomy and pulpectomy is generally based on the severity of the symptoms clinically and/or radiographically. When indicated, the primary tooth pulpotomy is a relatively simple procedure with generally good clinical results.

Conditions

Necrosis

Keywords

clean; Primary Root canal; rotary instrumentation

Outcome Measures

Primary Outcomes (1)

• Clinical Success

  Defined as teeth that exhibited no symptoms of pain, tenderness to percussion, swelling, sinus tract, or pathological mobility

  clean and shape with a scale and an average of 3 weeks

Secondary Outcomes (1)

• Radiological success

  obtain the evaluation in about 5 days

Study Arms (3)

Control group

EXPERIMENTAL

Control Group (n= 15): the root canals were prepared manually with K-files (Dentsply-Maillefer, Ballaigues, Switzerland) and "step back technique" up to size #35.

Procedure: Clean and shape Control group; Procedure: Cleand and shape Group 1; Procedure: Clean and shape Group 2

Group 1

EXPERIMENTAL

Group 1 (n= 15): the root canals were instrumented with rotary LightSpeed LSX instruments (Discus Dental, Culver City, CA, USA). They were used to complete the canal preparation to a size #50 for the anteriors and molar teeth to size #40.

Procedure: Clean and shape Control group; Procedure: Cleand and shape Group 1; Procedure: Clean and shape Group 2

Group 2

EXPERIMENTAL

Group 2 (n= 15): root canals were instrumented with ProTaper Next (Dentsply Maillefer, Ballaigues, Switzerland) using X1, X2 to X3. 0.5% NaOCl was used for irrigation.

Procedure: Clean and shape Control group; Procedure: Cleand and shape Group 1; Procedure: Clean and shape Group 2

Interventions

Clean and shape Control group PROCEDURE

For the control group the root canals were prepared manually with K-files and "step back technique" up to size #35. For this group were administered Tylenol

Control group; Group 1; Group 2

Cleand and shape Group 1 PROCEDURE

For the Group 1, LightSpeed LSX rotary instruments (Discus Dental, Culver City, CA, USA) were used to complete the canal preparation to a size #50 for the anteriors and molars to size #40. After procedures were administered Tylenol

Control group; Group 1; Group 2

Clean and shape Group 2 PROCEDURE

For the group 2 the root canals were instrumented with ProTaper files using X1, X2 (21mm) to X3 (21mm). 0.5% NaOCl was used for irrigation, the original protocol suggested by ProTaper for permanent teeth was simplified for this study. After clinical procedures Tylenol were administered

Control group; Group 1; Group 2

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• the aims and requirements of the study were freely accepted by the parents
• primary molars with at least 11.0 ± 1.0 mm of working length
• Treatment was limited to patients in good health;
• All teeth had vital and non-vital pulps without a sinus tract;
• Excess of bleeding during a pulpotomy;
• Presence of enough coronal tooth and root structure;
• No prior pulpectomy treatment on the involved tooth,
• absence of perforation in the internal and/or external furcation area and
• No analgesics or antibiotics were used before the clinical procedures began.

You may not qualify if:

• had a positive history of antibiotic use within the past month,
• diabetic, hemophilic
• if the tooth had root resorption or been previously accessed and initiated a pulpectomy.

Sponsors & Collaborators

• Universidad Autonoma de Baja California: lead

Study Sites (4)

Jorge Paredes Vieyra

Tijuana, Baja Califronia, 22000, Mexico

Location

Jorge Paredes Vieyra

Tijuana, Estado de Baja California, 22000, Mexico

Location

Jose Clemente Orozco

Tijuana, Estado de Baja California, 22000, Mexico

Location

Jose Clemente

Tijuana, Estado de Baja California, 22000, Mexico

Location

Related Publications (1)

• Paredes-Vieyra J, Enriquez FJ. Success rate of single- versus two-visit root canal treatment of teeth with apical periodontitis: a randomized controlled trial. J Endod. 2012 Sep;38(9):1164-9. doi: 10.1016/j.joen.2012.05.021. Epub 2012 Jul 26.

  PMID: 22892729 RESULT

MeSH Terms

Conditions

Necrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Certified endodontists trained in the procedures, devices, and systems investigated took part in the research. All experts tracked a pre-established procedure for Rotary instrument systems and Endo vac system.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Post graduate Programs in Dentistry

Model Details: All clinical procedures and measurements were conducted by the author. A #0 periapical radiograph was taken for each tooth in buccolingual projection to allow proper selection. The selected teeth included 7 second maxillary molars (three canals each), 9 first maxillary molars (2 canals each), 3 central incisors (one canal each), 18 first mandibular molars (2 canals each), 8 second mandibular molars (three canals each) for a total of 45 teeth with 102 canals (Table 1). A standard session time recommended by the pedodontists was approximately 20-35 minutes in length to allow for acceptable time for completion of treatment. All treatment was performed by the author. As a novel treatment in Pedodontics, were included electronic apex locator (EAL), EndoVac system and two rotary systems: LightSpeed LSX instruments and ProTaper Next.

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: December 10, 2018
• Study Start: January 1, 2019
• Primary Completion: February 15, 2019
• Study Completion: September 20, 2019
• Last Updated: September 26, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (4)