Electrical and Formocresol Pulpotomy in Primary Molars

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University Hospital Case Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Gerald Feretti, DDS, MS, MPH, University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT01622153
First received: June 14, 2012
Last updated: June 18, 2012
Last verified: June 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 University Hospital Case Medical Center:

Primary Outcome Measures:
  • Radiographic [ Time Frame: 6, 12, and 18 months ] [ Designated as safety issue: No ]
    Failure is identified as radiographic: furcation radiolucency, external root resorption


Secondary Outcome Measures:
  • Clinical [ Time Frame: 6, 12, 18 months ] [ Designated as safety issue: No ]
    Failure determined by clinical presence of: mobility, abscess, spontaneous pain, suppuration


Estimated Enrollment: 120
Study Start Date: June 2011
Estimated Study Completion Date: June 2014
Estimated 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

Ages Eligible for Study:   3 Years to 8 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01622153

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

No publications provided

Responsible Party: Gerald Feretti, DDS, MS, MPH, Chair of Pediatric Dentistry, University Hospital Case Medical Center
ClinicalTrials.gov Identifier: NCT01622153     History of Changes
Other Study ID Numbers: 021117
Study First Received: June 14, 2012
Last Updated: June 18, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 18, 2014