Trial Outcomes & Findings for Bioactive Glass (Sol-gel) for Alveolar Bone Regeneration After Surgical Extraction (NCT NCT01878084)
NCT ID: NCT01878084
Last Updated: 2020-02-18
Results Overview
The primary objective of the study is to determine the effect of using bioactive glass in preservation of alveolar crestal height and width surgical sockets immediately after premolar extraction assessed at baseline, 1,2,4,8,12,24 weeks post-extraction, baseline ,4 and 12 weeks reported. This change was analyzed by subtracting the values of each interval from the baseline values.the positive values indicate that the alveolar crest is coronal to the cemento enaml junction (reference point) , while the negative values indicate that the alveolar crest in apical to the cemento enamel junction (reference point)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
assessed at baseline, 1,2,4,8,12,24 weeks post-extraction, baseline,4 and 12 weeks reported.
Results posted on
2020-02-18
Participant Flow
participants were recruited from the outpatient clinic of the orthodontic department at the Faculty of Dentistry of Alexandria University From October 2013 to October 2014
Unit of analysis: extraction socket
Participant milestones
| Measure |
All Study Participants
Bone regeneration utilizing tissue engineering principles and approach via using porous bioactive glass prepared by sol gel technique to properly fill the empty socket after tooth extraction. The target is to preserve the buccal and lingual alveolar plates of the socket regarding width and height, to avoid bone resorption and to stimulate bone regeneration. This novel technique will be evaluated via histological (biopsy), radiographic, and bone density measurements in addition to clinical assessment.
This study represents a split-mouth study where the right or left/ upper or lower premolar could be assigned to either the control group (socket left empty) or test group (socket filled with bioactive glass (sol-gel)
The extraction sockets will be allocated either to the control : Extraction socket will be left empty
or
Test: Extraction socket will be augmented using bioactive glass (sol-gel)
|
|---|---|
|
Overall Study
STARTED
|
9 18
|
|
Overall Study
Test(Received TAMP Bioglass) s
|
7 7
|
|
Overall Study
Control (Sockets Were Left Empty)
|
7 7
|
|
Overall Study
COMPLETED
|
7 14
|
|
Overall Study
NOT COMPLETED
|
2 4
|
Reasons for withdrawal
| Measure |
All Study Participants
Bone regeneration utilizing tissue engineering principles and approach via using porous bioactive glass prepared by sol gel technique to properly fill the empty socket after tooth extraction. The target is to preserve the buccal and lingual alveolar plates of the socket regarding width and height, to avoid bone resorption and to stimulate bone regeneration. This novel technique will be evaluated via histological (biopsy), radiographic, and bone density measurements in addition to clinical assessment.
This study represents a split-mouth study where the right or left/ upper or lower premolar could be assigned to either the control group (socket left empty) or test group (socket filled with bioactive glass (sol-gel)
The extraction sockets will be allocated either to the control : Extraction socket will be left empty
or
Test: Extraction socket will be augmented using bioactive glass (sol-gel)
|
|---|---|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
Bioactive Glass (Sol-gel) for Alveolar Bone Regeneration After Surgical Extraction
Baseline characteristics by cohort
| Measure |
All Study Participants
n=7 Participants
Bone regeneration utilizing tissue engineering principles and approach via using porous bioactive glass prepared by sol gel technique to properly fill the empty socket after tooth extraction. The target is to preserve the buccal and lingual alveolar plates of the socket regarding width and height, to avoid bone resorption and to stimulate bone regeneration. This novel technique will be evaluated via histological (biopsy), radiographic, and bone density measurements in addition to clinical assessment.
This study represents a split-mouth study where the right or left/ upper or lower premolar could be assigned to either the control group (socket left empty) or test group (socket filled with bioactive glass (sol-gel)
The extraction sockets will be allocated either to the control : Extraction socket will be left empty
or
Test: Extraction socket will be augmented using bioactive glass (sol-gel)
|
|---|---|
|
Age, Continuous
|
12 years
STANDARD_DEVIATION 1.38 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Egyptians
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Egypt
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: assessed at baseline, 1,2,4,8,12,24 weeks post-extraction, baseline,4 and 12 weeks reported.Population: previously described
The primary objective of the study is to determine the effect of using bioactive glass in preservation of alveolar crestal height and width surgical sockets immediately after premolar extraction assessed at baseline, 1,2,4,8,12,24 weeks post-extraction, baseline ,4 and 12 weeks reported. This change was analyzed by subtracting the values of each interval from the baseline values.the positive values indicate that the alveolar crest is coronal to the cemento enaml junction (reference point) , while the negative values indicate that the alveolar crest in apical to the cemento enamel junction (reference point)
Outcome measures
| Measure |
All Study Participants
n=14 extraction sockets
This study represented a split-mouth study where the right or left/ upper or lower premolar was assigned to either the control group (socket left empty) or test group (socket filled with bioactive glass (sol-gel)
The extraction sockets were allocated either to the control : Extraction socket were left empty
or
Test: Extraction socket were augmented using bioactive glass (sol-gel
bioactive glass (sol-gel): Extraction sockets were augmented using bioactive glass (sol-gel)
|
|---|---|
|
Change in Alveolar Crestal Bone Height
4 weeks control distal alveolar bone height value
|
1 mm
Standard Deviation 1.28
|
|
Change in Alveolar Crestal Bone Height
12 weeks control mesial alveolar bone height value
|
-0.13 mm
Standard Deviation 0.25
|
|
Change in Alveolar Crestal Bone Height
baseline control mesial alveolar bone height value
|
0.32 mm
Standard Deviation 0.76
|
|
Change in Alveolar Crestal Bone Height
baseline test mesial alveolar bone height value
|
0.84 mm
Standard Deviation 1.57
|
|
Change in Alveolar Crestal Bone Height
baseline control distal alveolar bone height value
|
1.59 mm
Standard Deviation 1.03
|
|
Change in Alveolar Crestal Bone Height
baseline test distal alveolar bone height value
|
0.96 mm
Standard Deviation 1.57
|
|
Change in Alveolar Crestal Bone Height
4 weeks control mesial alveolar bone height value
|
-0.11 mm
Standard Deviation 0.95
|
|
Change in Alveolar Crestal Bone Height
4 weeks test mesial alveolar bone height value
|
-0.36 mm
Standard Deviation 1.40
|
|
Change in Alveolar Crestal Bone Height
4 weeks test distal alveolar bone height value
|
0.03 mm
Standard Deviation 1.76
|
|
Change in Alveolar Crestal Bone Height
12 weeks test mesial alveolar bone height value
|
0.08 mm
Standard Deviation 1.09
|
|
Change in Alveolar Crestal Bone Height
12 weeks control distal alveolar bone height value
|
0.33 mm
Standard Deviation 0.8
|
|
Change in Alveolar Crestal Bone Height
12 weeks test distal alveolar bone height value
|
0.47 mm
Standard Deviation 0.98
|
PRIMARY outcome
Timeframe: assessed at baseline, 1,2,4,8,12,24 weeks post-extraction, baseline,4 and 12 weeks reported.Population: previously described
The primary objective of the study is to determine the effect of using bioactive glass in inducing alveolar bone regeneration safely and effectively in surgical sockets immediately after premolar extraction assessed at baseline, 1,2,4,8,12,24 weeks post-extraction, baseline,4 and 12 weeks reported.
Outcome measures
| Measure |
All Study Participants
n=14 extraction sockets
This study represented a split-mouth study where the right or left/ upper or lower premolar was assigned to either the control group (socket left empty) or test group (socket filled with bioactive glass (sol-gel)
The extraction sockets were allocated either to the control : Extraction socket were left empty
or
Test: Extraction socket were augmented using bioactive glass (sol-gel
bioactive glass (sol-gel): Extraction sockets were augmented using bioactive glass (sol-gel)
|
|---|---|
|
Bone Mineral Density
baseline control coronal bone density value
|
38.30 percentage of BMD
Standard Deviation 14.94
|
|
Bone Mineral Density
baseline test coronal bone density value
|
42.28 percentage of BMD
Standard Deviation 19.50
|
|
Bone Mineral Density
baseline control middle bone density value
|
63.32 percentage of BMD
Standard Deviation 16.20
|
|
Bone Mineral Density
baseline test middle bone density value
|
55.92 percentage of BMD
Standard Deviation 17.24
|
|
Bone Mineral Density
baseline control apical bone density value
|
75.17 percentage of BMD
Standard Deviation 13.12
|
|
Bone Mineral Density
baseline test apical bone density value
|
75.61 percentage of BMD
Standard Deviation 16.72
|
|
Bone Mineral Density
4 weeks control coronal bone density value
|
39.54 percentage of BMD
Standard Deviation 17.14
|
|
Bone Mineral Density
4 weeks test coronal bone density value
|
40.03 percentage of BMD
Standard Deviation 14.83
|
|
Bone Mineral Density
4 weeks control middle bone density value
|
67.29 percentage of BMD
Standard Deviation 18.28
|
|
Bone Mineral Density
4 weeks test middle bone density value
|
68.95 percentage of BMD
Standard Deviation 16.94
|
|
Bone Mineral Density
4 weeks control apical bone density value
|
76.47 percentage of BMD
Standard Deviation 14.42
|
|
Bone Mineral Density
4 weeks test apical bone density value
|
83.98 percentage of BMD
Standard Deviation 13.30
|
|
Bone Mineral Density
12 weeks control coronal bone density value
|
47.71 percentage of BMD
Standard Deviation 14.85
|
|
Bone Mineral Density
12 weeks test coronal bone density value
|
49.44 percentage of BMD
Standard Deviation 13.92
|
|
Bone Mineral Density
12 weeks control middle bone density value
|
66.59 percentage of BMD
Standard Deviation 15.76
|
|
Bone Mineral Density
12 weeks test middle bone density value
|
67.14 percentage of BMD
Standard Deviation 11.05
|
|
Bone Mineral Density
12 weeks control apical bone density value
|
74.10 percentage of BMD
Standard Deviation 12.08
|
|
Bone Mineral Density
12 weeks test apical bone density value
|
76.15 percentage of BMD
Standard Deviation 13.41
|
Adverse Events
All Study Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place