Phase 2
Completed N=70
MTA/FS Pulpotomy for Vital Primary Incisors: A Randomized Controlled Trial
Dental Caries · Dental Pulp Exposure
Source: ClinicalTrials.gov NCT02019563 ↗
Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcomePrimary: Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Acceptable Radiographic Outcome at 12 Months Post-procedure. — .97; .92 Proportion of incisors — p=.15
Summary
To compare radiographic and clinical outcomes and survival of mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy and root canal therapy (RCT) in carious vital primary maxillary incisors.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Acceptable Radiographic Outcome at 12 Months Post-procedure. |
.97; .92 | .15 |
| PRIMARY Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Acceptable Radiographic Outcomes 18 Months Post-procedure. |
.93; .92 | .38 |
| SECONDARY Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Unacceptable Clinical Outcome at 12 Months Post-procedure. |
.98; 1.0 | .51 |
| SECONDARY Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Unacceptable Clinical Outcome at 18 Months Post-procedure. |
.97; .98 | .64 |
| SECONDARY MTA/FS Pulpotomy and RCT Treated Incisor Survival |
1; .97; .94; .97 | .11 |
Eligibility Criteria
Inclusion Criteria
- children with one or more carious primary maxillary incisors where removal of dental caries will likely to produce a vital pulp exposure
- reside in the GTA at time of inclusion
- English-speaking
Exclusion Criteria
- history of spontaneous or lingering stimulated pain, swelling, fistula or sinus tract, tenderness to percussion and pathological mobility
- incisors with preoperative radiographic evidence of periapical or periradicular radiolucency, a widened periodontal ligament space, physiological resorption, incomplete root formation, internal or external root resorption, pulp canal obliteration or pulp calcifications
- non-restorable tooth
Data sourced from ClinicalTrials.gov (NCT02019563). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.