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Electrical and Formocresol Pulpotomy in Primary Molars

This study has been terminated.
(Use of Formocresol for pulpotomies ws discontinued.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01622153
First Posted: June 18, 2012
Last Update Posted: May 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gerald Feretti, DDS, MS, MPH, University Hospitals Cleveland Medical Center
  Purpose
  1. The investigator hypothesize that the Laser pulpotomy will provide adequate and comparable success clinically in primary molars.
  2. The investigators hypothesize that the Laser pulpotomy will provide adequate and comparable success radiographically in primary molars.

Condition Intervention
Reversible Pulpitis Caries Procedure: Formocresol application after pulpotomy preparation Procedure: GENTLEray 980 Soft Tissue diode laser

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Study and Clinical Evaluation of Pre & Post Operative Treatment Comparison of Electrical and Formocresol Pulpotomy Procedures in Primary Molars of Children Undergoing General Anesthesia

Resource links provided by NLM:


Further study details as provided by Gerald Feretti, DDS, MS, MPH, University Hospitals Cleveland Medical Center:

Primary Outcome Measures:
  • Radiographic [ Time Frame: 6, 12, and 18 months ]
    Failure is identified as radiographic: furcation radiolucency, external root resorption


Secondary Outcome Measures:
  • Clinical [ Time Frame: 6, 12, 18 months ]
    Failure determined by clinical presence of: mobility, abscess, spontaneous pain, suppuration


Estimated Enrollment: 120
Study Start Date: June 2011
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Formocresol (control)
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
1:5 Buckley's Formocresol dilution applied for 5 minutes or until hemostasis achieved
Other Name: Buckley's solution, baby root canal, primary root canal
Active Comparator: Laser
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
Application to pulp chamber until hemostasis achieved
Other Name: soft tissue laser, electrosurgery, baby root canal

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Excluded will be primary molars with clinical or radiographic signs of pathology
  2. Children not within age range
  3. Absence of parent/caregiver
  4. Mentally disabled parent/caregiver
  5. Patients not returning for 6 month and 12 month follow up examination appointment
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01622153


Locations
United States, Ohio
University Hospital-Rainbow Babies & Children's Hospital
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Investigators
Principal Investigator: Gerald A Ferretti, DDS, MS, MPH University Hospitals Cleveland Medical Center
  More Information

Responsible Party: Gerald Feretti, DDS, MS, MPH, Chair of Pediatric Dentistry, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT01622153     History of Changes
Other Study ID Numbers: 021117
First Submitted: June 14, 2012
First Posted: June 18, 2012
Last Update Posted: May 10, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Pulpitis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Hemostatics
Coagulants