Use of Formocresol for pulpotomies ws discontinued.
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
Sponsor study identifier
interventional
120
1 country
1
Study Start
June 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2014
Actual (reported)Study Completion
June 2014
Actual (reported)Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2014
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2011
Date type not reportedThis date has not been verified as actual or estimated.
June 14, 2012
Actual (reported)June 18, 2012
Actual (reported)June 2014
Actual (reported)June 2014
Actual (reported)Radiographic
Failure is identified as radiographic: furcation radiolucency, external root resorption
6, 12, and 18 months
Clinical
6, 12, 18 months
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.
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.
1:5 Buckley's Formocresol dilution applied for 5 minutes or until hemostasis achieved
Application to pulp chamber until hemostasis achieved
University Hospital-Rainbow Babies & Children's Hospital
Cleveland, Ohio, 44106, United States
Gerald A Ferretti, DDS, MS, MPH
University Hospitals Cleveland Medical Center
First Submitted
June 14, 2012
First Posted
June 18, 2012
Study Start
June 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2014
Effectiveness of Toothbrushing Techniques in Plaque Removal and Caries Lesion Control
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Study Completion
June 2014
Actual (reported)Last Updated
May 10, 2017
Record last verified: 2017-05
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