Clinical Trial Results:
A phase III, randomized, controlled clinical pilot trial of lateral ridge augmentation using autogenous bone blocks or xenogenic bone block grafts loaded with recombinant human bone morphogenic protein 2
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Summary
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EudraCT number |
2012-002002-46 |
Trial protocol |
AT |
Global end of trial date |
15 Mar 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
04 Jun 2020
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First version publication date |
04 Jun 2020
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
2012-BMP1-2
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Additional study identifiers
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ISRCTN number |
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US NCT number |
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WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
Medical University of Graz
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Sponsor organisation address |
Billrothgasse 4, Graz, Austria, 8010
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Public contact |
Department für zahnärztl. Chirurgie, Universitätsklinik für Zahn-, Mund- und Kieferheilkunde, Med Uni Graz, 0043 31638513280, mi.payer@medunigraz.at
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Scientific contact |
Department für zahnärztl. Chirurgie, Universitätsklinik für Zahn-, Mund- und Kieferheilkunde, Med Uni Graz, 0043 31638513280, mi.payer@medunigraz.at
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
02 May 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
15 Mar 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
15 Mar 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Primary objective: To compare patient’s perception and acceptance as well as efficacy of xenogenic bone block grafts loaded with rh-BMP-2 on bone quantity and quality 4 months after augmentation surgery to the gold standard (autogenous bone blocks).
Secondary objectives: Safety and tolerability of xenogenic bone block grafts loaded with rh- BMP-2 in regard of complications (soft-tissue/adverse effect) and the change in bone quantity over time.
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Protection of trial subjects |
The study was conducted according to principles of Good Clinical Practice and approved by the local Ethics Committees.
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Background therapy |
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Evidence for comparator |
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Actual start date of recruitment |
15 Apr 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Austria: 10
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Country: Number of subjects enrolled |
Switzerland: 15
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Worldwide total number of subjects |
25
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EEA total number of subjects |
10
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
20
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From 65 to 84 years |
5
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85 years and over |
0
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Recruitment
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Recruitment details |
Recruitment started in 2013 and the last study visit took place in 2019. 25 patients were included in total, one patient had to be excluded from the study. 24 patients completed the study. | |||||||||||||||
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Pre-assignment
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Screening details |
In 23 out of 24 patients originally included, the augmentation procedure was considered to be successful. In one patient in the control group, the augmentation procedure failed. Since this patient refused to undergo another surgical procedure, he was excluded from the present study and replaced by an additional patient. | |||||||||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||
Blinding implementation details |
Blinding of the study dentists and patients was not possible based on the nature of the study and the preparation involved (second surgery site in control group).
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Study group | |||||||||||||||
Arm description |
CE-marked medical device Bio-Oss Spongiosa Block® (xenogenic bone) loaded with InductOs® (1.5 mg Dibotermin alfa / ml) covered with Bio-Gide® (collagen membrane). | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
InductOs
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Dental gel
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Routes of administration |
Dental use
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Dosage and administration details |
In the course of this study InductOs was implanted during dental augmentation surgery.
InductOs (1,5 mg Dibotermin alfa) was applied to the CE-marked medical device Bio-Oss Spongiosa Block® (xenogenic bone) and covered with Bio-Gide ®, a collagen membrane.
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Arm title
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Control group | |||||||||||||||
Arm description |
Autogenous bone block in combination with CE-marked medical device Bio-Oss® (xenogenic bone granules) covered with Bio-Gide® (collagen membrane). | |||||||||||||||
Arm type |
Medical device | |||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
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End points reporting groups
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Reporting group title |
Study group
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Reporting group description |
CE-marked medical device Bio-Oss Spongiosa Block® (xenogenic bone) loaded with InductOs® (1.5 mg Dibotermin alfa / ml) covered with Bio-Gide® (collagen membrane). | ||
Reporting group title |
Control group
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Reporting group description |
Autogenous bone block in combination with CE-marked medical device Bio-Oss® (xenogenic bone granules) covered with Bio-Gide® (collagen membrane). | ||
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End point title |
ridge width at the implant shoulder | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
4 months after augmentation surgery
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Statistical analysis title |
Ridge width in mm | |||||||||
Statistical analysis description |
The median ridge width increased from 4.0 mm (Q1 = 2.0; Q3 = 4.0) (test) and 2.0 mm(Q1 = 2.0; Q3 = 3.0) (control) to 7.0 mm (Q1 = 6.0; Q3 = 8.0) (test) and 7.0 mm (Q1 = 6.0; Q3 = 8.0) (control) at 4 months (intergroup p > .05).
The differences between the groups were not statistically significant.
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Comparison groups |
Study group v Control group
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Number of subjects included in analysis |
24
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Analysis specification |
Pre-specified
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Analysis type |
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P-value |
≤ 0.05 | |||||||||
Method |
Wilcoxon (Mann-Whitney) | |||||||||
Confidence interval |
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End point title |
Patient-reported outcome measures | |||||||||
End point description |
The following parameters were analyzed:
pain during surgery recipient site
pain during surgery donor site
pain after surgery recipient site
pain after surgery donor site
swelling after surgery recipient site
swelling after surgery donor site
willingness to repeat treatment
There were no statistically significant differences, except for Pain during surgery at the recipient site in favour of the test group.
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End point type |
Secondary
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End point timeframe |
4 months
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| No statistical analyses for this end point | ||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
From Informed Consent to last patient's visit.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
22
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Reporting groups
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Reporting group title |
All enrolled patients
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Reporting group description |
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
