Electrical and Formocresol Pulpotomy in Primary Molars

NCT01622153 | Terminated

• 1 other identifier: 021117
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.The investigator hypothesize that the Laser pulpotomy will provide adequate and comparable success clinically in primary molars.
2. 2.The investigators hypothesize that the Laser pulpotomy will provide adequate and comparable success radiographically in primary molars.

Conditions

Reversible Pulpitis; Caries

Outcome Measures

Primary Outcomes (1)

• Radiographic

  Failure is identified as radiographic: furcation radiolucency, external root resorption

  6, 12, and 18 months

Secondary Outcomes (1)

• Clinical

  6, 12, 18 months

Study Arms (2)

Formocresol (control)

PLACEBO COMPARATOR

This will consist of patients who are ASA I or II status, 3-8 years old, males and females, and present with restorable primary molars with reversible pulpitis and free of clinical radiographic signs of pulp pathology. From these study participants, they will be randomly assigned to this or other group. Patients in this group will receive a pulpotomy. Cotton pellets are saturated with conventional 1:5 dilution of Buckley's formocresol into the canal orifice for 5 minutes for complete hemostasis. IRM (Zinc Oxide Eugenol) cement will then be placed to seal the pulp chamber. A stainless steel crown will be cemented with Ketac Cement that was triturated for 10 seconds to complete the pulpotomy procedure and final restoration.

Procedure: Formocresol application after pulpotomy preparation

Laser

ACTIVE COMPARATOR

This will consist of patients who are ASA I or II status, 3-8 years old, males and females, and present with restorable primary molars with reversible pulpitis and free of clinical radiographic signs of pulp pathology. From these study participants, they will be randomly assigned to this or other group. Patients in this group will receive a pulpotomy. Then a GENTLEray 980 Soft Tissue diode laser (Power: 3.0W, Mode: PW, Fiber: 300µm, Ton: 100ms, Toff: 100ms, Timer: cont) will be used to vaporize the residual pulp tissue and complete hemostasis. IRM (Zinc Oxide Eugenol) cement is then placed to seal the pulp chamber. A stainless steel crown cemented with Ketac Cement for the full coverage final restoration completes the pulpotomy procedure.

Procedure: GENTLEray 980 Soft Tissue diode laser

Interventions

Formocresol application after pulpotomy preparation PROCEDURE

1:5 Buckley's Formocresol dilution applied for 5 minutes or until hemostasis achieved

Also known as: Buckley's solution, baby root canal, primary root canal

Formocresol (control)

GENTLEray 980 Soft Tissue diode laser PROCEDURE

Application to pulp chamber until hemostasis achieved

Also known as: soft tissue laser, electrosurgery, baby root canal

Laser

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Restorable carious primary molars with reversible pulpitis and free of clinical or radiographic signs of pulp pathology
• Males and females
• Children ages 3-8 years old
• Children classified under ASA I or II status

You may not qualify if:

• Excluded will be primary molars with clinical or radiographic signs of pathology
• Children not within age range
• Absence of parent/caregiver
• Mentally disabled parent/caregiver
• Patients not returning for 6 month and 12 month follow up examination appointment

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospital-Rainbow Babies & Children's Hospital

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Interventions

Electrosurgery

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Gerald A Ferretti, DDS, MS, MPH

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Pediatric Dentistry

Study Record Dates

• First Submitted: June 14, 2012
• First Posted: June 18, 2012
• Study Start: June 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: May 10, 2017

Record last verified: 2017-05

Locations

US (1)