N/A
N=86
Bone Regenerative Techniques in Endodontic Microsurgery
Apical Periodontitis
Bottom Line
View on ClinicalTrials.gov: NCT04514991 ↗Enrolled (actual)
86
Serious AEs
—
Results posted
Nov 2022
Primary outcome: Primary: 2D Radiographic Healing at 12 Months Follow up (Overall Cases) — 24; 29; 1; 1 osteotomy site
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Foundation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 2D Radiographic Healing at 12 Months Follow up (Overall Cases) |
24; 29; 1; 1; 3; 3 | — |
| PRIMARY 3D Radiographic Healing at 12 Months Follow up (Overall Cases) |
11; 22; 14; 10; 5; 4 | — |
| PRIMARY 2D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only) |
23; 28; 1; 1; 1; 2 | — |
| PRIMARY 3D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only) |
10; 21; 14; 10; 2; 1 | — |
| SECONDARY C Score (Overall Cases) |
13; 23; 12; 9; 5; 4 | — |
| SECONDARY C Score (Asymptomatic Cases Only) |
12; 22; 12; 9; 2; 1 | — |
Summary
The purpose of this randomized controlled clinical trial was to evaluate two dimensionally and 3-dimensionally the effect of resorbable collagen-based bone filling material on periapical healing following endodontic microsurgery (EMS) on endodontic lesions presenting four-wall defect.
Eligibility Criteria
Inclusion Criteria
- Healthy adult.
- Intact coronal restoration with no sign of leakage.
- Class B (small lesion) and C (large lesion) periapical lesions. (Kim and Kratchman 2006)
Exclusion Criteria
- Patients with medical conditions and contraindications to surgery.
- Minors.
- Pregnancy.
- Teeth with signs of coronal leakage.
- Teeth with vertical root fractures.
Data sourced from ClinicalTrials.gov (NCT04514991). 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.