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

Reversible Pulpitis Clinical Trial

— MTA  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02702505
• Other study ID #: 072015-041
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: March 3, 2016
• Last updated: March 7, 2016
• Start date: November 2014
• Est. completion date: December 2017

Study information

• Verified date: March 2016
• Source: Texas A & M University Baylor College Of Dentistry
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 8 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Pulp Diseases
• Reversible Pulpitis

Intervention

Biological:
• NeoMTA
A new formulation of MTA was developed in which bismuth oxide was omitted

Other:
• ProRoot MTA
Control group

Locations

Country	Name	City	State
United States	Texas A & M University Baylor College of Dentistry	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas A & M University Baylor College Of Dentistry

Country where clinical trial is conducted

United States, 

References & Publications (18)

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.

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. — View Citation

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Guelmann M, Bookmyer KL, Villalta P, García-Godoy F. Microleakage of restorative techniques for pulpotomized primary molars. J Dent Child (Chic). 2004 Sep-Dec;71(3):209-11. — View 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. — View Citation

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. — View 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. — View 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. — View Citation

Holland R, de Souza V, Murata SS, Nery MJ, Bernabé PF, Otoboni Filho JA, Dezan Júnior 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. — View 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. — View Citation

Maroto M, Barbería E, Planells P, García Godoy F. Dentin bridge formation after mineral trioxide aggregate (MTA) pulpotomies in primary teeth. Am J Dent. 2005 Jun;18(3):151-4. — View 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. — View 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. Epub 2006 Sep 26. Review. — View Citation

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Color stability	Dental intraoral photographs will evaluated	2 years	No
Primary	Internal resorption	Dental radiographs will be evaluatedresorption	2 years	No
Primary	external resorption	Dental radiographs will be evaluated resorption	2 years	No
Primary	Bone loss	Dental radiographs will be evaluated for intraradicular or periapical bone loss	2 years	No
Primary	Widening of periodontal ligament space	Dental radiographs will be evaluated for widening of the PDL space	2 years	No