Phase 2
N=24
Use of Mineral Trioxide Aggregate in the Treatment of Traumatized Teeth
Periapical Diseases
Bottom Line
View on ClinicalTrials.gov: NCT02625298 ↗Enrolled (actual)
24
Serious AEs
—
Results posted
Jul 2017
Primary outcome: Primary: Changes Between Initial and Post Treatment Dimensions of Periapical Lesions — 37.34; 34.04; 16.20; 17.54 square millimeters — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ProRoot MTA (Device); MTA+ Cerkamed (Device)
- Age
- Pediatric, Adult · 7+ yrs
- Sex
- All
- Sponsor
- Association of Paediatric and Preventive Dentists of Serbia
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes Between Initial and Post Treatment Dimensions of Periapical Lesions |
37.34; 34.04; 16.20; 17.54; 12.74; 12.01 | <0.01 sig |
| SECONDARY Presence of Clinical Symptoms |
5; 5; 8; 6; 3; 1 | — |
Summary
Traumatic tooth injuries are common in children and adolescents, and often result in pulpal necrosis and the development of periapical lesions. Treatment of traumatized teeth with endodontic complications depends on the type of injury, number of injured teeth, root development and patient cooperation, which altogether will create a challenge and dictate the treatment plan for the dentist. The purpose of this study was to assess the effectiveness of non-surgical root canal procedures in traumatized permanent teeth with necrotic pulps and chronic periapical lesions using a tri-antibiotic paste and calcium-hydroxide as intracanal medications and two different mineral trioxide aggregate (MTA) products for definitive obturation.
Eligibility Criteria
Inclusion Criteria
- Healthy patient
- Non-vital tooth with chronic periapical lesions
- Restorable tooth
- No horizontal or vertical root fractures
- No root resorption
Exclusion Criteria
- Unrestorable tooth
- Horizontal or vertical root fractures
- Root resorption
Data sourced from ClinicalTrials.gov (NCT02625298). 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.