Trial Outcomes & Findings for Bone Regenerative Techniques in Endodontic Microsurgery (NCT NCT04514991)
NCT ID: NCT04514991
Last Updated: 2022-11-21
Results Overview
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.
COMPLETED
NA
67 participants
12 months
2022-11-21
Participant Flow
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.
Unit of analysis: Osteotomy sites
Participant milestones
| Measure |
Endodontic Microsurgery Only
Surgical sites assigned to this group receive Endodontic microsurgery procedure.
|
Endodontic Microsurgery + Foundation
Surgical sites assigned to this group receive 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.
|
|---|---|---|
|
Overall Study
STARTED
|
41 41
|
45 45
|
|
Overall Study
COMPLETED
|
30 30
|
36 36
|
|
Overall Study
NOT COMPLETED
|
11 11
|
9 9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Endodontic Microsurgery Only
n=41 Lesions
Surgical sites assigned to this group received Endodontic microsurgery procedure.
|
Foundation+ Endodontic Microsurgery
n=45 Lesions
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.
|
Total
n=86 Lesions
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
10 Lesions
n=41 Lesions
|
17 Lesions
n=45 Lesions
|
27 Lesions
n=86 Lesions
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Arch
Maxilla
|
26 Lesions
n=41 Lesions
|
29 Lesions
n=45 Lesions
|
55 Lesions
n=86 Lesions
|
|
Arch
Mandible
|
15 Lesions
n=41 Lesions
|
16 Lesions
n=45 Lesions
|
31 Lesions
n=86 Lesions
|
|
Tooth Type
Anterior
|
16 Lesions
n=41 Lesions • Randomization and analysis unit per periapical lesion . Some participants had multiple teeth with multiple lesions or multirooted teeth with separate lesions.
|
19 Lesions
n=45 Lesions • Randomization and analysis unit per periapical lesion . Some participants had multiple teeth with multiple lesions or multirooted teeth with separate lesions.
|
35 Lesions
n=86 Lesions • Randomization and analysis unit per periapical lesion . Some participants had multiple teeth with multiple lesions or multirooted teeth with separate lesions.
|
|
Tooth Type
Posterior
|
25 Lesions
n=41 Lesions • Randomization and analysis unit per periapical lesion . Some participants had multiple teeth with multiple lesions or multirooted teeth with separate lesions.
|
26 Lesions
n=45 Lesions • Randomization and analysis unit per periapical lesion . Some participants had multiple teeth with multiple lesions or multirooted teeth with separate lesions.
|
51 Lesions
n=86 Lesions • Randomization and analysis unit per periapical lesion . Some participants had multiple teeth with multiple lesions or multirooted teeth with separate lesions.
|
|
Age, Categorical
<=18 years
|
0 Lesions
n=41 Lesions • Randomization and analysis unit per periapical lesion . Some participants had multiple teeth with multiple lesions or multirooted teeth with separate lesions.
|
0 Lesions
n=45 Lesions • Randomization and analysis unit per periapical lesion . Some participants had multiple teeth with multiple lesions or multirooted teeth with separate lesions.
|
0 Lesions
n=86 Lesions • Randomization and analysis unit per periapical lesion . Some participants had multiple teeth with multiple lesions or multirooted teeth with separate lesions.
|
|
Age, Categorical
Between 18 and 65 years
|
33 Lesions
n=41 Lesions • Randomization and analysis unit per periapical lesion . Some participants had multiple teeth with multiple lesions or multirooted teeth with separate lesions.
|
40 Lesions
n=45 Lesions • Randomization and analysis unit per periapical lesion . Some participants had multiple teeth with multiple lesions or multirooted teeth with separate lesions.
|
73 Lesions
n=86 Lesions • Randomization and analysis unit per periapical lesion . Some participants had multiple teeth with multiple lesions or multirooted teeth with separate lesions.
|
|
Age, Categorical
>=65 years
|
8 Lesions
n=41 Lesions • Randomization and analysis unit per periapical lesion . Some participants had multiple teeth with multiple lesions or multirooted teeth with separate lesions.
|
5 Lesions
n=45 Lesions • Randomization and analysis unit per periapical lesion . Some participants had multiple teeth with multiple lesions or multirooted teeth with separate lesions.
|
13 Lesions
n=86 Lesions • Randomization and analysis unit per periapical lesion . Some participants had multiple teeth with multiple lesions or multirooted teeth with separate lesions.
|
|
Sex: Female, Male
Female
|
31 Lesions
n=41 Lesions
|
28 Lesions
n=45 Lesions
|
59 Lesions
n=86 Lesions
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Analysis completed per osteotomy site.
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.
Outcome measures
| Measure |
Control
n=30 osteotomy site
Surgical sites assigned to this group received endodontic microsurgery procedure.
|
Treatment
n=36 osteotomy site
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.
|
|---|---|---|
|
2D Radiographic Healing at 12 Months Follow up (Overall Cases)
Complete healing
|
24 osteotomy site
|
29 osteotomy site
|
|
2D Radiographic Healing at 12 Months Follow up (Overall Cases)
Incomplete healing
|
1 osteotomy site
|
1 osteotomy site
|
|
2D Radiographic Healing at 12 Months Follow up (Overall Cases)
Uncertain healing
|
3 osteotomy site
|
3 osteotomy site
|
|
2D Radiographic Healing at 12 Months Follow up (Overall Cases)
Unsatisfactory healing
|
2 osteotomy site
|
3 osteotomy site
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Analysis completed per osteotomy site.
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.
Outcome measures
| Measure |
Control
n=30 osteotomy sites
Surgical sites assigned to this group received endodontic microsurgery procedure.
|
Treatment
n=36 osteotomy sites
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.
|
|---|---|---|
|
3D Radiographic Healing at 12 Months Follow up (Overall Cases)
Complete
|
11 osteotomy sites
|
22 osteotomy sites
|
|
3D Radiographic Healing at 12 Months Follow up (Overall Cases)
Limited
|
14 osteotomy sites
|
10 osteotomy sites
|
|
3D Radiographic Healing at 12 Months Follow up (Overall Cases)
Unsatisfactory
|
5 osteotomy sites
|
4 osteotomy sites
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Analysis per osteotomy. Excluded participants presenting with symptoms.
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.
Outcome measures
| Measure |
Control
n=26 osteotomy site
Surgical sites assigned to this group received endodontic microsurgery procedure.
|
Treatment
n=32 osteotomy site
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.
|
|---|---|---|
|
2D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only)
Uncertain
|
1 osteotomy site
|
2 osteotomy site
|
|
2D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only)
Unsatisfactory
|
1 osteotomy site
|
1 osteotomy site
|
|
2D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only)
Complete
|
23 osteotomy site
|
28 osteotomy site
|
|
2D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only)
Incomplete
|
1 osteotomy site
|
1 osteotomy site
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Analysis per osteotomy site. Excluded participants with symptoms.
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
Outcome measures
| Measure |
Control
n=26 osteotomy sites
Surgical sites assigned to this group received endodontic microsurgery procedure.
|
Treatment
n=32 osteotomy sites
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.
|
|---|---|---|
|
3D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only)
Complete
|
10 osteotomy sites
|
21 osteotomy sites
|
|
3D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only)
Limited
|
14 osteotomy sites
|
10 osteotomy sites
|
|
3D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only)
Unsatisfactory
|
2 osteotomy sites
|
1 osteotomy sites
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Analysis per osteotomy site.
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).
Outcome measures
| Measure |
Control
n=30 osteotomy sites
Surgical sites assigned to this group received endodontic microsurgery procedure.
|
Treatment
n=36 osteotomy sites
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.
|
|---|---|---|
|
C Score (Overall Cases)
C-Score 2
|
13 osteotomy sites
|
23 osteotomy sites
|
|
C Score (Overall Cases)
C-score 1
|
12 osteotomy sites
|
9 osteotomy sites
|
|
C Score (Overall Cases)
C-score 0
|
5 osteotomy sites
|
4 osteotomy sites
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Analysis per osteotomy site. Excluded participants with symptoms.
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).
Outcome measures
| Measure |
Control
n=26 osteotomy sites
Surgical sites assigned to this group received endodontic microsurgery procedure.
|
Treatment
n=32 osteotomy sites
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.
|
|---|---|---|
|
C Score (Asymptomatic Cases Only)
C-score 2
|
12 osteotomy sites
|
22 osteotomy sites
|
|
C Score (Asymptomatic Cases Only)
C-score 1
|
12 osteotomy sites
|
9 osteotomy sites
|
|
C Score (Asymptomatic Cases Only)
C-score 0
|
2 osteotomy sites
|
1 osteotomy sites
|
Adverse Events
Endodontic Microsurgery
Endodontic Microsurgery + Foundation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Bekir Karabucak
University of Pennsylvania- Endodontic Department
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place