A Phase 4 interventional study of NeoMTA and ProRoot MTA in Reversible Pulpitis and Dental Pulp Diseases, sponsored by Texas A & M University Baylor College Of Dentistry. Status unknown at 1 site in United States. Open to participants aged 2 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-08.
Sponsored by Texas A & M University Baylor College Of Dentistry · Phase 4, Interventional, and Treatment
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.
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.
130 studies on the registry are indexed under Dental Pulp Diseases; 37 are open to participants now.
This study's enrollment of 50 is close to the median of 52 across 108 interventional studies indexed under Dental Pulp Diseases.
Browse Dental Pulp Diseases studies →Texas A & M University Baylor College Of Dentistry is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Children between the ages of 2 ½ and 8 years of age
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
A new formulation of MTA was developed in which bismuth oxide was omitted
Control group
Color stability
Dental intraoral photographs will evaluated
Time frame: 2 years
Internal resorption
Dental radiographs will be evaluatedresorption
Time frame: 2 years
external resorption
Dental radiographs will be evaluated resorption
Time frame: 2 years
Bone loss
Dental radiographs will be evaluated for intraradicular or periapical bone loss
Time frame: 2 years
Widening of periodontal ligament space
Dental radiographs will be evaluated for widening of the PDL space
Time frame: 2 years
This study is status unknown, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Texas A & M University Baylor College Of Dentistry