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Success and Color Stability of MTA Pulpotomized Primary Molars: an RCT (MTA)

Primary Purpose

Reversible Pulpitis, Dental Pulp Diseases

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
NeoMTA
ProRoot MTA
Sponsored by
Texas A & M University Baylor College Of Dentistry
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Reversible Pulpitis focused on measuring Pulp, pulpotomies, mineral trioxide aggregate

Eligibility Criteria

2 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • • Children between the ages of 2 ½ and 8 years of age

    • Patient must have two, contralateral primary molars that are matched for type of molar (first or second), size of carious lesion (same level of approximation of carious lesion to the pulp), and arch (maxillary or mandibular) that are treatment planned for a pulpotomy
    • The teeth selected for the study must be vital and asymptomatic both clinically and radiographically or only display symptoms consistent with reversible pulptitis
    • The teeth selected for the study must be anticipated to be retained in the mouth for at least two years
    • Each patient must have an updated medical history form in the dental record, be examined by the operator, and be classified as ASA I or II (in good general health)

Exclusion Criteria:

  • Teeth with a history of spontaneous pain
  • Teeth with radiographic evidence of internal or external resorption, intraradicular or periapical bone loss, loss of lamina dura, or widening of the periodontal ligament space

Sites / Locations

  • Texas A & M University Baylor College of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

NeoMTA

ProRoot MTA

Arm Description

The new formulation of MTA (does not contain bismuth oxide) will be used in one tooth receiving a pulpotomy to determine if the color of the tooth changes over time. The new formulation has received the Food and Drug Administrations 510(k) substantial equivalence clearance for Class II dental materials and is equivalent to its MTA predicate (ProRoot, Dentsply Tulsa Dental, Tulsa, OK, USA).19

Control group. This group will receive the old formulation of MTA in the pulpotomy and the tooth will receive a full coverage stainless steel crown restoration.

Outcomes

Primary Outcome Measures

Color stability
Dental intraoral photographs will evaluated
Internal resorption
Dental radiographs will be evaluatedresorption
external resorption
Dental radiographs will be evaluated resorption
Bone loss
Dental radiographs will be evaluated for intraradicular or periapical bone loss
Widening of periodontal ligament space
Dental radiographs will be evaluated for widening of the PDL space

Secondary Outcome Measures

Full Information

First Posted
March 3, 2016
Last Updated
March 7, 2016
Sponsor
Texas A & M University Baylor College Of Dentistry
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1. Study Identification

Unique Protocol Identification Number
NCT02702505
Brief Title
Success and Color Stability of MTA Pulpotomized Primary Molars: an RCT
Acronym
MTA
Official Title
Success and Color Stability of MTA Pulpotomized Primary Molars: an RCT
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas A & M University Baylor College Of Dentistry

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Mineral trioxide aggregate has been previously FDA approved as an endodontic filler. Its use in vital teeth has demonstrated significant color change post-treatment leaving it ineffective for esthetic use.. The new formulation will be tested to see if has the same effect.
Detailed Description
This randomized control, split-mouth trial will use 50 pediatric subjects selected from the patient population in the pediatric dental clinics at Baylor College of Dentistry and in select faculty private practices. The study will use a within-subject control design whereby one tooth will be treated with a pulpotomy using the new formulation of MTA (NeoMTA Plus, Avalon Biomed Inc., Bradenton, FL, USA) and restored with a multi-surface composite, and the other tooth with an MTA pulpotomy and restored with a SSC; thus, approximately 50 teeth will be treated for each treatment group. The restoration type will be randomized as to which side will receive the SSC or composite using sealed, opaque envelopes. Approximately 50 subjects will be needed for the study in order to elicit any significant findings as demonstrated by a power analysis from a similar study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reversible Pulpitis, Dental Pulp Diseases
Keywords
Pulp, pulpotomies, mineral trioxide aggregate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NeoMTA
Arm Type
Experimental
Arm Description
The new formulation of MTA (does not contain bismuth oxide) will be used in one tooth receiving a pulpotomy to determine if the color of the tooth changes over time. The new formulation has received the Food and Drug Administrations 510(k) substantial equivalence clearance for Class II dental materials and is equivalent to its MTA predicate (ProRoot, Dentsply Tulsa Dental, Tulsa, OK, USA).19
Arm Title
ProRoot MTA
Arm Type
Other
Arm Description
Control group. This group will receive the old formulation of MTA in the pulpotomy and the tooth will receive a full coverage stainless steel crown restoration.
Intervention Type
Biological
Intervention Name(s)
NeoMTA
Intervention Description
A new formulation of MTA was developed in which bismuth oxide was omitted
Intervention Type
Other
Intervention Name(s)
ProRoot MTA
Intervention Description
Control group
Primary Outcome Measure Information:
Title
Color stability
Description
Dental intraoral photographs will evaluated
Time Frame
2 years
Title
Internal resorption
Description
Dental radiographs will be evaluatedresorption
Time Frame
2 years
Title
external resorption
Description
Dental radiographs will be evaluated resorption
Time Frame
2 years
Title
Bone loss
Description
Dental radiographs will be evaluated for intraradicular or periapical bone loss
Time Frame
2 years
Title
Widening of periodontal ligament space
Description
Dental radiographs will be evaluated for widening of the PDL space
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • Children between the ages of 2 ½ and 8 years of age Patient must have two, contralateral primary molars that are matched for type of molar (first or second), size of carious lesion (same level of approximation of carious lesion to the pulp), and arch (maxillary or mandibular) that are treatment planned for a pulpotomy The teeth selected for the study must be vital and asymptomatic both clinically and radiographically or only display symptoms consistent with reversible pulptitis The teeth selected for the study must be anticipated to be retained in the mouth for at least two years Each patient must have an updated medical history form in the dental record, be examined by the operator, and be classified as ASA I or II (in good general health) Exclusion Criteria: Teeth with a history of spontaneous pain Teeth with radiographic evidence of internal or external resorption, intraradicular or periapical bone loss, loss of lamina dura, or widening of the periodontal ligament space
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn A Kerins, DDS, PhD
Organizational Affiliation
Texas A & M University Baylor College Of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas A & M University Baylor College of Dentistry
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15344622
Citation
Agamy HA, Bakry NS, Mounir MM, Avery DR. Comparison of mineral trioxide aggregate and formocresol as pulp-capping agents in pulpotomized primary teeth. Pediatr Dent. 2004 Jul-Aug;26(4):302-9.
Results Reference
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PubMed Identifier
16161395
Citation
Farsi N, Alamoudi N, Balto K, Mushayt A. Success of mineral trioxide aggregate in pulpotomized primary molars. J Clin Pediatr Dent. 2005 Summer;29(4):307-11. doi: 10.17796/jcpd.29.4.n80t77w625118k73.
Results Reference
background
PubMed Identifier
15926290
Citation
Holan G, Eidelman E, Fuks AB. Long-term evaluation of pulpotomy in primary molars using mineral trioxide aggregate or formocresol. Pediatr Dent. 2005 Mar-Apr;27(2):129-36.
Results Reference
background
Citation
4. Jabbarifar SE, Khademi D, Ghasemi D. Success rates of formocresol pulpotomy versus mineral trioxide aggregate in human primary molar tooth. J Res Med Sci 2004; 9(6)L 55-8.
Results Reference
background
PubMed Identifier
17138165
Citation
Peng L, Ye L, Tan H, Zhou X. Evaluation of the formocresol versus mineral trioxide aggregate primary molar pulpotomy: a meta-analysis. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Dec;102(6):e40-4. doi: 10.1016/j.tripleo.2006.05.017. Epub 2006 Sep 26.
Results Reference
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PubMed Identifier
10969431
Citation
Farooq NS, Coll JA, Kuwabara A, Shelton P. Success rates of formocresol pulpotomy and indirect pulp therapy in the treatment of deep dentinal caries in primary teeth. Pediatr Dent. 2000 Jul-Aug;22(4):278-86.
Results Reference
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PubMed Identifier
16532888
Citation
Guelmann M, Fair J, Bimstein E. Permanent versus temporary restorations after emergency pulpotomies in primary molars. Pediatr Dent. 2005 Nov-Dec;27(6):478-81.
Results Reference
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PubMed Identifier
12064493
Citation
Holan G, Fuks AB, Ketlz N. Success rate of formocresol pulpotomy in primary molars restored with stainless steel crown vs amalga. Pediatr Dent. 2002 May-Jun;24(3):212-6.
Results Reference
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PubMed Identifier
18477438
Citation
Caceda JH. The use of resin-based composite restorations in pulpotomized primary molars. J Dent Child (Chic). 2007 May-Aug;74(2):147-50.
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PubMed Identifier
17073200
Citation
Cehreli ZC, Cetinguc A, Cengiz SB, Altay AN. Clinical performance of pulpotomized primary molars restored with resin-based materials. 24-month results. Am J Dent. 2006 Oct;19(5):262-6.
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15871455
Citation
Guelmann M, Bookmyer KL, Villalta P, Garcia-Godoy F. Microleakage of restorative techniques for pulpotomized primary molars. J Dent Child (Chic). 2004 Sep-Dec;71(3):209-11.
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Citation
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Citation
Hutcheson C, Seale NS, McWhorter A, Kerins C, Wright J. Multi-surface composite vs stainless steel crown restorations after mineral trioxide aggregate pulpotomy: a randomized controlled trial. Pediatr Dent. 2012 Nov-Dec;34(7):460-7.
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PubMed Identifier
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Citation
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Citation
Parirokh M, Asgary S, Eghbal MJ, Stowe S, Eslami B, Eskandarizade A, Shabahang S. A comparative study of white and grey mineral trioxide aggregate as pulp capping agents in dog's teeth. Dent Traumatol. 2005 Jun;21(3):150-4. doi: 10.1111/j.1600-9657.2005.00311.x.
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Citation
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Citation
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Success and Color Stability of MTA Pulpotomized Primary Molars: an RCT

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