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

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ClinicalTrials.gov Identifier: NCT02019563
Recruitment Status : Completed
First Posted : December 24, 2013
Results First Posted : February 11, 2016
Last Update Posted : February 11, 2016
Sponsor:
Information provided by (Responsible Party):
Peter Judd, The Hospital for Sick Children

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.

Condition or disease Intervention/treatment Phase
Dental Caries Dental Pulp Exposure Procedure: RCT Group Procedure: MTA/FS pulpotomy Group Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mineral Trioxide Aggregate/Ferric Sulfate Pulpotomy for Vital Primary Incisors: A Randomized Controlled Trial
Study Start Date : September 2010
Actual Primary Completion Date : May 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals

Arm Intervention/treatment
Experimental: MTA/FS pulpotomy Group
Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).
Procedure: MTA/FS pulpotomy Group
After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface.

Active Comparator: RCT Group
Children randomized to this group will undergo the root canal therapy (RCT) technique.
Procedure: RCT Group
After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children with one or more carious primary maxillary incisors where removal of dental caries will likely to produce a vital pulp exposure
  • reside in the GTA at time of inclusion
  • English-speaking

Exclusion Criteria:

  • history of spontaneous or lingering stimulated pain, swelling, fistula or sinus tract, tenderness to percussion and pathological mobility
  • incisors with preoperative radiographic evidence of periapical or periradicular radiolucency, a widened periodontal ligament space, physiological resorption, incomplete root formation, internal or external root resorption, pulp canal obliteration or pulp calcifications
  • non-restorable tooth

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): NCT02019563


Locations
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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Peter Judd, DDS The Hospital for Sick Children, Toronto Canada

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Responsible Party: Peter Judd, Dentist-in-Chief, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02019563     History of Changes
Other Study ID Numbers: 1000019443
First Posted: December 24, 2013    Key Record Dates
Results First Posted: February 11, 2016
Last Update Posted: February 11, 2016
Last Verified: February 2016
Keywords provided by Peter Judd, The Hospital for Sick Children:
pediatrics
dental caries
dental pulp exposure
incisor
Additional relevant MeSH terms:
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Dental Caries
Dental Pulp Exposure
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Dental Pulp Diseases