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

NCT02702505 | Unknown Phase 4

• 1 other identifier: 072015-041
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Reversible Pulpitis; Dental Pulp Diseases

Keywords

Pulp; pulpotomies; mineral trioxide aggregate

Outcome Measures

Primary Outcomes (5)

• Color stability

  Dental intraoral photographs will evaluated

  2 years

• Internal resorption

  Dental radiographs will be evaluatedresorption

  2 years

• external resorption

  Dental radiographs will be evaluated resorption

  2 years

• Bone loss

  Dental radiographs will be evaluated for intraradicular or periapical bone loss

  2 years

• Widening of periodontal ligament space

  Dental radiographs will be evaluated for widening of the PDL space

  2 years

Study Arms (2)

NeoMTA

EXPERIMENTAL

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

Biological: NeoMTA

ProRoot MTA

OTHER

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.

Other: ProRoot MTA

Interventions

NeoMTA BIOLOGICAL

A new formulation of MTA was developed in which bismuth oxide was omitted

NeoMTA

ProRoot MTA OTHER

Control group

ProRoot MTA

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas A & M University Baylor College Of Dentistry: lead

Study Sites (1)

Texas A & M University Baylor College of Dentistry

Dallas, Texas, 75246, United States

Location

Related Publications (18)

• 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.

  PMID: 15344622 BACKGROUND

• 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.

  PMID: 16161395 BACKGROUND

• 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.

  PMID: 15926290 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 17138165 BACKGROUND

• 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.

  PMID: 10969431 BACKGROUND

• 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.

  PMID: 16532888 BACKGROUND

• 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.

  PMID: 12064493 BACKGROUND

• Caceda JH. The use of resin-based composite restorations in pulpotomized primary molars. J Dent Child (Chic). 2007 May-Aug;74(2):147-50.

  PMID: 18477438 BACKGROUND

• 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.

  PMID: 17073200 BACKGROUND

• 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.

  PMID: 15871455 BACKGROUND

• Guelmann M, McIlwain MF, Primosch RE. Radiographic assessment of primary molar pulpotomies restored with resin-based materials. Pediatr Dent. 2005 Jan-Feb;27(1):24-7.

  PMID: 15839391 BACKGROUND

• 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.

  PMID: 23265162 BACKGROUND

• Maroto M, Barberia E, Planells P, Garcia Godoy F. Dentin bridge formation after mineral trioxide aggregate (MTA) pulpotomies in primary teeth. Am J Dent. 2005 Jun;18(3):151-4.

  PMID: 16158803 BACKGROUND

• 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.

  PMID: 15876326 BACKGROUND

• Holland R, de Souza V, Murata SS, Nery MJ, Bernabe PF, Otoboni Filho JA, Dezan Junior E. Healing process of dog dental pulp after pulpotomy and pulp covering with mineral trioxide aggregate or Portland cement. Braz Dent J. 2001;12(2):109-13.

  PMID: 11445912 BACKGROUND

• American Academy on Pediatric Dentistry Clinical Affairs Committee-Pulp Therapy subcommittee; American Academy on Pediatric Dentistry Council on Clinical Affairs. Guideline on pulp therapy for primary and young permanent teeth. Pediatr Dent. 2008-2009;30(7 Suppl):170-4. No abstract available.

  PMID: 19216417 BACKGROUND

• Zurn D, Seale NS. Light-cured calcium hydroxide vs formocresol in human primary molar pulpotomies: a randomized controlled trial. Pediatr Dent. 2008 Jan-Feb;30(1):34-41.

  PMID: 18402097 BACKGROUND

MeSH Terms

Conditions

Dental Pulp Diseases

Interventions

ProRoot MTA

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Carolyn A Kerins, DDS, PhD

  Texas A & M University Baylor College Of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Graduate Program director

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: March 8, 2016
• Study Start: November 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 8, 2016

Record last verified: 2016-03

Locations

US (1)