Clinical trial NCT02702505: Success and Color Stability of MTA Pulpotomized Primary Molars: an RCT
Official title: Success and Color Stability of MTA Pulpotomized Primary Molars: an RCT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Reversible Pulpitis
Dental Pulp Diseases
Keywords: Pulp
pulpotomies
mineral trioxide aggregate
Lead sponsor: Texas A & M University Baylor College Of Dentistry
Sponsor class: OTHER
First posted: 2016-03-08
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Color stability
timeFrame: 2 years
measure: Internal resorption
timeFrame: 2 years
measure: external resorption
timeFrame: 2 years
measure: Bone loss
timeFrame: 2 years
measure: Widening of periodontal ligament space
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Texas A & M University Baylor College of Dentistry
state: Texas
Study officials:
affiliation: Texas A & M University Baylor College Of Dentistry
name: Carolyn A Kerins, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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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.
citation: 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.
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. No abstract available.
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