Reversible Pulpitis Clinical Trial
— MTAOfficial title:
Success and Color Stability of MTA Pulpotomized Primary Molars: an RCT
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.
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Texas A & M University Baylor College of Dentistry | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
Texas A & M University Baylor College Of Dentistry |
United States,
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
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* Note: There are 18 references in all — Click here to view all references
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 |
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