Healing After Endodontic Microsurgery Using Resorbable Collagen Based Bone Augmentation Material: A Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pennsylvania
- Enrollment
- 67
- Locations
- 1
- Primary Endpoint
- 2D Radiographic Healing at 12 Months Follow up (Overall Cases)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
- •Pregnancy.
- •Teeth with signs of coronal leakage.
- •Teeth with vertical root fractures.
Arms & Interventions
Treatment
Surgical sites (osteotomy) assigned to this group received endodontic microsurgery procedure+ Foundation (J. Morita USA).
Intervention: Foundation (Device)
Control
Surgical sites (osteotomy) assigned to this group receives endodontic microsurgery procedure only.
Outcomes
Primary Outcomes
2D Radiographic Healing at 12 Months Follow up (Overall Cases)
Time Frame: 12 months
Periapical healing was assessed by qualitatively evaluating bone regeneration through PA radiographs using well-established criteria. Molven's criteria categorize healing using periapical films into four categories: complete healing, incomplete healing, uncertain and unsatisfactory healing.
3D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only)
Time Frame: 12 months
Periapical healing was assessed by qualitatively evaluating bone regeneration through CBCT scans using Penn 3D criteria. Cases were classified into complete, limited, or unsatisfactory healing
3D Radiographic Healing at 12 Months Follow up (Overall Cases)
Time Frame: 12 months
Periapical healing was assessed by qualitatively evaluating bone regeneration through CBCT scans using Penn 3D criteria. Cases were classified into complete, limited, or unsatisfactory healing.
2D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only)
Time Frame: 12 months
Periapical healing was assessed by qualitatively evaluating bone regeneration through PA radiographs using well-established criteria. Molven's criteria categorize healing using periapical films into four categories: complete healing, incomplete healing, uncertain and unsatisfactory healing.
Secondary Outcomes
- C Score (Asymptomatic Cases Only)(12 months)
- C Score (Overall Cases)(12 months)