Bone Regenerative Techniques in Endodontic Microsurgery

Study Overview
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Brief Summary
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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.

Official Title
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Healing After Endodontic Microsurgery Using Resorbable Collagen Based Bone Augmentation Material: A Randomized Controlled Clinical Trial

Conditions
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Apical Periodontitis

Intervention / Treatment
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* Device: Foundation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Surgical sites (osteotomy) assigned to this group received endodontic microsurgery procedure+ Foundation (J. Morita USA). | Device: Foundation<br>* Collagen-based, bone filling augmentation material used to stimulate bone formation in extraction sockets or bone defects in the alveolar ridge.<br>|
| No Intervention: Control<br>Surgical sites (osteotomy) assigned to this group receives endodontic microsurgery procedure only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2D Radiographic Healing at 12 Months Follow up (Overall Cases) | 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. | 12 months | 
| 3D Radiographic Healing at 12 Months Follow up (Overall Cases) | 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. | 12 months | 
| 2D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only) | 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. | 12 months | 
| 3D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only) | 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 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C Score (Overall Cases) | Cortical plate healing using RAC/B index as evaluated on CBCT scans. Score 0: Cortical plate not re-established (Nonhealed). Score 1: Cortical plate is partially re-established (Partially healed). Score 2: Cortical plate is re-established (Completely healed). | 12 months | 
| C Score (Asymptomatic Cases Only) | Cortical plate healing using RAC/B index as evaluated on CBCT scans. Score 0: Cortical plate not re-established (Nonhealed). Score 1: Cortical plate is partially re-established (Partially healed). Score 2: Cortical plate is re-established (Completely healed). | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Persistent periapical pathology