Apical Periodontitis
Conditions
Keywords
Persistent periapical pathology
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.
Interventions
DEVICEFoundation
Collagen-based, bone filling augmentation material used to stimulate bone formation in extraction sockets or bone defects in the alveolar ridge.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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. * Minors. * Pregnancy. * Teeth with signs of coronal leakage. * Teeth with vertical root fractures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2D Radiographic Healing at 12 Months Follow up (Overall Cases) | 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 (Overall Cases) | 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) | 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) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| C Score (Overall Cases) | 12 months | 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). |
| C Score (Asymptomatic Cases Only) | 12 months | 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). |
Countries
United States
Participant flow
Recruitment details
Start date of recruitment: 09/03/2019 End date of recruitment: 12/15/2020 Patients were consecutively enrolled until March 10th, 2020, after which all clinical and research activity was suspended due to the COVID-19 pandemic. The study was resumed in August 11th, 2020.
Participants by arm
| Arm | Count |
|---|---|
| Endodontic Microsurgery Only Surgical sites assigned to this group received Endodontic microsurgery procedure. | 41 |
| Endodontic Microsurgery Only Surgical sites assigned to this group received Endodontic microsurgery procedure. | 41 |
| Foundation+ Endodontic Microsurgery Surgical sites assigned to this group received Endodontic microsurgery procedure+ Foundation (J. Morita USA).
Foundation: Collagen-based, bone filling augmentation material used to stimulate bone formation in extraction sockets or bone defects in the alveolar ridge. | 45 |
| Foundation+ Endodontic Microsurgery Surgical sites assigned to this group received Endodontic microsurgery procedure+ Foundation (J. Morita USA).
Foundation: Collagen-based, bone filling augmentation material used to stimulate bone formation in extraction sockets or bone defects in the alveolar ridge. | 45 |
| Total | 172 |
Baseline characteristics
| Characteristic | Foundation+ Endodontic Microsurgery | Endodontic Microsurgery Only | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Lesions | 0 Lesions | 0 Lesions |
| Age, Categorical >=65 years | 5 Lesions | 8 Lesions | 13 Lesions |
| Age, Categorical Between 18 and 65 years | 40 Lesions | 33 Lesions | 73 Lesions |
| Arch Mandible | 16 Lesions | 15 Lesions | 31 Lesions |
| Arch Maxilla | 29 Lesions | 26 Lesions | 55 Lesions |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 28 Lesions | 31 Lesions | 59 Lesions |
| Sex: Female, Male Male | 17 Lesions | 10 Lesions | 27 Lesions |
| Tooth Type Anterior | 19 Lesions | 16 Lesions | 35 Lesions |
| Tooth Type Posterior | 26 Lesions | 25 Lesions | 51 Lesions |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: 12 months
Population: Analysis per osteotomy. Excluded participants presenting with symptoms.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Control | 2D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only) | Complete | 23 osteotomy site |
| Control | 2D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only) | Incomplete | 1 osteotomy site |
| Control | 2D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only) | Uncertain | 1 osteotomy site |
| Control | 2D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only) | Unsatisfactory | 1 osteotomy site |
| Treatment | 2D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only) | Unsatisfactory | 1 osteotomy site |
| Treatment | 2D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only) | Complete | 28 osteotomy site |
| Treatment | 2D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only) | Uncertain | 2 osteotomy site |
| Treatment | 2D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only) | Incomplete | 1 osteotomy site |
Primary
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.
Time frame: 12 months
Population: Analysis completed per osteotomy site.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Control | 2D Radiographic Healing at 12 Months Follow up (Overall Cases) | Complete healing | 24 osteotomy site |
| Control | 2D Radiographic Healing at 12 Months Follow up (Overall Cases) | Incomplete healing | 1 osteotomy site |
| Control | 2D Radiographic Healing at 12 Months Follow up (Overall Cases) | Uncertain healing | 3 osteotomy site |
| Control | 2D Radiographic Healing at 12 Months Follow up (Overall Cases) | Unsatisfactory healing | 2 osteotomy site |
| Treatment | 2D Radiographic Healing at 12 Months Follow up (Overall Cases) | Unsatisfactory healing | 3 osteotomy site |
| Treatment | 2D Radiographic Healing at 12 Months Follow up (Overall Cases) | Complete healing | 29 osteotomy site |
| Treatment | 2D Radiographic Healing at 12 Months Follow up (Overall Cases) | Uncertain healing | 3 osteotomy site |
| Treatment | 2D Radiographic Healing at 12 Months Follow up (Overall Cases) | Incomplete healing | 1 osteotomy site |
Primary
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
Time frame: 12 months
Population: Analysis per osteotomy site. Excluded participants with symptoms.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Control | 3D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only) | Complete | 10 osteotomy sites |
| Control | 3D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only) | Limited | 14 osteotomy sites |
| Control | 3D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only) | Unsatisfactory | 2 osteotomy sites |
| Treatment | 3D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only) | Complete | 21 osteotomy sites |
| Treatment | 3D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only) | Limited | 10 osteotomy sites |
| Treatment | 3D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only) | Unsatisfactory | 1 osteotomy sites |
Primary
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.
Time frame: 12 months
Population: Analysis completed per osteotomy site.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Control | 3D Radiographic Healing at 12 Months Follow up (Overall Cases) | Complete | 11 osteotomy sites |
| Control | 3D Radiographic Healing at 12 Months Follow up (Overall Cases) | Limited | 14 osteotomy sites |
| Control | 3D Radiographic Healing at 12 Months Follow up (Overall Cases) | Unsatisfactory | 5 osteotomy sites |
| Treatment | 3D Radiographic Healing at 12 Months Follow up (Overall Cases) | Complete | 22 osteotomy sites |
| Treatment | 3D Radiographic Healing at 12 Months Follow up (Overall Cases) | Limited | 10 osteotomy sites |
| Treatment | 3D Radiographic Healing at 12 Months Follow up (Overall Cases) | Unsatisfactory | 4 osteotomy sites |
Secondary
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).
Time frame: 12 months
Population: Analysis per osteotomy site. Excluded participants with symptoms.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Control | C Score (Asymptomatic Cases Only) | C-score 2 | 12 osteotomy sites |
| Control | C Score (Asymptomatic Cases Only) | C-score 1 | 12 osteotomy sites |
| Control | C Score (Asymptomatic Cases Only) | C-score 0 | 2 osteotomy sites |
| Treatment | C Score (Asymptomatic Cases Only) | C-score 2 | 22 osteotomy sites |
| Treatment | C Score (Asymptomatic Cases Only) | C-score 1 | 9 osteotomy sites |
| Treatment | C Score (Asymptomatic Cases Only) | C-score 0 | 1 osteotomy sites |
Secondary
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).
Time frame: 12 months
Population: Analysis per osteotomy site.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Control | C Score (Overall Cases) | C-Score 2 | 13 osteotomy sites |
| Control | C Score (Overall Cases) | C-score 1 | 12 osteotomy sites |
| Control | C Score (Overall Cases) | C-score 0 | 5 osteotomy sites |
| Treatment | C Score (Overall Cases) | C-score 0 | 4 osteotomy sites |
| Treatment | C Score (Overall Cases) | C-Score 2 | 23 osteotomy sites |
| Treatment | C Score (Overall Cases) | C-score 1 | 9 osteotomy sites |