Clinical Trial: MTA/FS Pulpotomy for Vital Primary Incisors: A Randomized Controlled Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Mineral Trioxide Aggregate/Ferric Sulfate Pulpotomy for Vital Primary Incisors: A Randomized Controlled Trial

Brief Summary: To compare radiographic and clinical outcomes and survival of mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy and root canal therapy (RCT) in carious vital primary maxillary incisors.

Detailed Summary: Dental caries is the most common chronic disease in children. Caries of the primary maxillary incisors is common in young children; often necessitating either extraction or pulp therapy. The premature loss of primary maxillary incisors can adversely affect a child's dental occlusion, ability to properly size food boluses for swallowing, speech articulation, facial esthetics and psychosocial development. Pulp treatment of cariously exposed vital primary incisors may prevent premature tooth loss as well as eliminate pain. Currently, there is a paucity of outcome investigations with regard to pulp therapy in primary incisors.
Sponsor: The Hospital for Sick Children

Current Primary Outcome:

• Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Acceptable Radiographic Outcome at 12 Months Post-procedure. [ Time Frame: 12 months after the procedure ]
  Two disinterested pediatric dentists classified each treated incisor into one of three outcomes: N=incisor without pathologic change; Po=pathologic change present, follow-up recommended; and Px=pathologic change present, extract. Incisors rated N or Po were considered an acceptable radiographic outcome while incisors rated as Px were considered unacceptable.
• Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Acceptable Radiographic Outcomes 18 Months Post-procedure. [ Time Frame: 18 months after the procedure ]
  Two disinterested pediatric dentists classified each treated incisor into one of three outcomes: N=incisor without pathologic change; Po=pathologic change present, follow-up recommended; and Px=pathologic change present, extract. Incisors rated N or Po were considered an acceptable radiographic outcome while incisors rated as Px were considered unacceptable.

Original Primary Outcome:

• Incisor Survival [ Time Frame: 1 year after the procedure ]
• Incisor Survival [ Time Frame: 2 years after the procedure ]

Current Secondary Outcome:

• Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Unacceptable Clinical Outcome at 12 Months Post-procedure. [ Time Frame: 12 months after the procedure ]
  Pulp treated incisors presenting with spontaneous pain, tenderness to percussion, fistula/sinus tract, soft tissue swelling and/or pathological tooth mobility were considered unacceptable clinical outcomes. Clinical outcomes between the MTA/FS pulpotomy and RCT groups were compared using Fisher's Exact test.
• Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Unacceptable Clinical Outcome at 18 Months Post-procedure. [ Time Frame: 18 months after the procedure ]
  Pulp treated incisors presenting with spontaneous pain, tenderness to percussion, fistula/sinus tract, soft tissue swelling and/or pathological tooth mobility were considered unacceptable clinical outcomes.
• MTA/FS Pulpotomy and RCT Treated Incisor Survival [ Time Frame: 12 and 18 months ]
  Kaplan-Meier survival curves were generated for the MTA/FS pulpotomy and RCT treatment groups. One treated incisor was selected by random draw from each subject for survival analysis to preserve independence of observations. The log-rank test was used to statistically compare survival of incisors.

Original Secondary Outcome: Presence of a number of clearly defined radiographic and clinical signs [ Time Frame: At 1 and 2 years after the procedure ]

Information By: The Hospital for Sick Children

Dates:
Date Received: December 18, 2013
Date Started: September 2010
Date Completion:
Last Updated: February 5, 2016
Last Verified: February 2016