Color Stability of NeoMTA Pulpotomized Primary Teeth

NCT03254290 | Unknown Early Phase 1

• 1 other identifier: TexasAMBaylor
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized control study will use 15 pediatric subjects selected from the patient population in the pediatric dental clinic at Children's Medical Center Dental Clinic (CMC Dental Clinic). 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 a formocresol pulpotomy and restored with a multi-surface composite; thus, approximately 15 teeth will be treated for each treatment group. The specific treated tooth will be randomized as to which side will receive the MTA or formocresol using sealed, opaque envelopes. Approximately 15 subjects will be needed for the study in order to elicit any significant findings as demonstrated by a power analysis.

Conditions

Dental Caries Extending to Pulp

Outcome Measures

Primary Outcomes (1)

• Color stability

  color scale (0=white/still esthetic; 1=slightly gray; 2=medium gray color; 3=dark gray

  3 month recall

Study Arms (2)

Experimental 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 FDAs 510(k) substantial equivalence clearance for Class II dental materials and is equivalent to its MTA predicate (ProRoot, Dentsply Tulsa Dental, Tulsa, OK, USA).

Biological: NeoMTA; Biological: Formocresol

Formocresol

ACTIVE COMPARATOR

Control group. This group will receive the "gold standard" formulation of a formocresol pulpotomy.

Biological: Formocresol

Interventions

NeoMTA BIOLOGICAL

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

Experimental NeoMTA

Formocresol BIOLOGICAL

Control group

Experimental NeoMTA; Formocresol

Eligibility Criteria

• Age: 30 Months - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children between the ages of 2 ½ and 9 years of age and be ASA I or ASA II. Patient must have two, primary teeth that are matched for, size of carious lesion (same level of approximation of carious lesion to the pulp) and are 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 eighteen months

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

Related Publications (19)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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.

  RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Seale NS. The use of stainless steel crowns. Pediatr Dent. 2002 Sep-Oct;24(5):501-5.

  PMID: 12412965 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Maroto M, Barberia E, Vera V, Garcia-Godoy F. Dentin bridge formation after white mineral trioxide aggregate (white MTA) pulpotomies in primary molars. Am J Dent. 2006 Apr;19(2):75-9.

  PMID: 16764128 RESULT

• Walsh RM, Woodmansey KF, Glickman GN, He J. Evaluation of compressive strength of hydraulic silicate-based root-end filling materials. J Endod. 2014 Jul;40(7):969-72. doi: 10.1016/j.joen.2013.11.018. Epub 2014 Jan 14.

  PMID: 24935545 RESULT

Related Links

• Avalon Biomed Inc 2014

MeSH Terms

Interventions

formocresol

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The teeth treated with each specific material will be randomly assigned by drawing a random number from a manilla folder
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Children between the ages of 2 ½ and 9 years of age and be ASA I or ASA II. Patient must have two, primary teeth that are matched for, size of carious lesion (same level of approximation of carious lesion to the pulp) and are 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 eighteen months

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: August 18, 2017
• Study Start: October 1, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: August 18, 2017

Record last verified: 2017-08