GBR and Autogenous Bone Chips
Primary Purpose
Bone Resorption
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Guided bone regeneration with or without autologous bone
Sponsored by
About this trial
This is an interventional treatment trial for Bone Resorption focused on measuring implants; GBR; DBBM; grafts; bone
Eligibility Criteria
Inclusion Criteria:
- > 18 years,
- in need of a solitary implant in quadrant 1 and 2 or quadrant 3 and 4 with simultaneous GBR procedure
- presence of a pre-operative CBCT.
Exclusion Criteria:
- smokers
- patients with systemic diseases that could interfere with the healing
- patients undergoing bisphosphonate treatment
- patients who previously received radiation therapy of the jaws
- patients that received a GBR procedure in the region of interest in the past.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Augmentation with autologous bone + DBBM
Augmentation with DBBM
Arm Description
A layer of autogenous bone chips was placed on the implant surface. On top of this a layer of DBBM (Bio-Oss™, Geistlich®, Wolhusen, Switserland) was placed, thereafter covered with a collagen membrane.
A layer of DBBM was placed on the implant surface and thereafter covered with a collagen membrane. Care was taken to make both augmentations as comparable as possible by weighting the used amount of graft material.
Outcomes
Primary Outcome Measures
Horizontal and vertical bone augmentation
The change of dimension was assessed comparing Cone Beam Computed Tomography scans (CBCT)
Secondary Outcome Measures
Success of grafting procedure as assessed by clinical interpretation
Defined as no persistent pain in the grafted area and no suppuration or expulsion of graft material and implant survival rates being lack of mobility, absence of peri-implant radiolucency, absence of recurrent peri-implant infection with suppuration, absence of continuous or recurrent pain, and no structural failure of the implant
Marginal bone level alterations assessed on peri-apical radiographs using software (ImageJ)
measured from a reference point (implant shoulder) to the most coronal point of BIC, both mesially and distally
Full Information
NCT ID
NCT03946020
First Posted
May 2, 2019
Last Updated
May 9, 2019
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT03946020
Brief Title
GBR and Autogenous Bone Chips
Official Title
Bovine Derived Xenograft in Combination With Autogenous Bone Chips Versus Xenograft Alone for the Augmentation of Bony Dehiscences Around Oral Implants: a Randomized, Controlled, Split-mouth Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2013 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
February 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will be an open, prospective, split-mouth, randomised controlled clinical trial. A total of 14 patients searching for oral implant treatment and where a GBR procedure is indicated per implant treatment will be enrolled.
All patients have to fulfill all of the inclusion criteria and none of the exclusion criteria. From all patients clinical photos will be taken.
Two sites within a patient will be randomly allocated to the 'autologous bone chips and DBBM or 'DBBM particles alone' group.
The study will be 1 year follow-up study comprising 9 visits
Detailed Description
A randomized controlled clinical trial (RCT) to compare the use of deproteinized bovine bone mineral (DBBM) in combination with autogenous bone chips versus a DBBM alone for the augmentation of bony dehiscence after dental implant placement
Objectives: 1. To test whether the use of DBBM is not inferior to the use of a combination of DBBM and autogenous bone chips for the filling of bony dehiscence around dental implants
2. To test whether a digital impression technique can be used to measure guided bone regeneration in comparison to conventional measurement with a dental probe and to compare these observations with cone beam CT images
Study Design: Randomized, controlled, single center, split mouth study
Study Population: Partially edentulous male or female patients in need for oral implants for a fixed prosthetic implant supported rehabilitation and where a Guide Bone Regeneration (GBR) procedure is indicated during implant treatment
Patient Number: 14
Duration of treatment: The time in the study for each patient will be 1 year and 4 months. The treatment period includes implant and abutment installation (in a twostage procedure), with a healing time of minimum 12 weeks before the start of the prosthetic phase.
Study devices: Implants: 3.3 / 4.1 / 4.8 mm Straumann Bone level implants Bone Graft: DBB (Demineralised Bovine Bone, Bio OSS) Measuring Devices: Cadent iTero & software and Dental Probes Prosthetics: Straumann (computer aided design computer aided manufacturing (CAD CAM) crowns and abutments
Outcome variables:
Primary outcome variable: Difference in bone fill between DBB + bone chips vs. DBB without bone chips afer 24 weeks of submerged healing. The "ideal bone volume" as defined at base line (= 100%) will be compared to the received bone fill [%] at re-entry measured by a digital impression technique (before and after GBR, and at abutment connection, before and after raising a flap, and at the 1-year follow-up).
The method of digital impression will be compared to CBCT immediately after implant placemetn and 1 year and periodontal probing during surgery and re-enty
Secondary Parameters:
Page 5 of 35 A comparison of 3 different tools (probe, CBCT and digital impression) for measuring the bone volume changes in relation to GBR procedures. Implant survival en success rates on a patient and implant level Marginal bone level alterations
Safety: Adverse Events / Adverse Device Effects
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Resorption
Keywords
implants; GBR; DBBM; grafts; bone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Split mouth
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Augmentation with autologous bone + DBBM
Arm Type
Active Comparator
Arm Description
A layer of autogenous bone chips was placed on the implant surface. On top of this a layer of DBBM (Bio-Oss™, Geistlich®, Wolhusen, Switserland) was placed, thereafter covered with a collagen membrane.
Arm Title
Augmentation with DBBM
Arm Type
Experimental
Arm Description
A layer of DBBM was placed on the implant surface and thereafter covered with a collagen membrane. Care was taken to make both augmentations as comparable as possible by weighting the used amount of graft material.
Intervention Type
Procedure
Intervention Name(s)
Guided bone regeneration with or without autologous bone
Intervention Description
Autogenous bone chips were collected. On each side a bone level implant was placed. The bone dehiscence was measured and was thereafter treated according to the GBR protocol. A resorbable native collagen was adapted to the defect.
Primary Outcome Measure Information:
Title
Horizontal and vertical bone augmentation
Description
The change of dimension was assessed comparing Cone Beam Computed Tomography scans (CBCT)
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Success of grafting procedure as assessed by clinical interpretation
Description
Defined as no persistent pain in the grafted area and no suppuration or expulsion of graft material and implant survival rates being lack of mobility, absence of peri-implant radiolucency, absence of recurrent peri-implant infection with suppuration, absence of continuous or recurrent pain, and no structural failure of the implant
Time Frame
1 year
Title
Marginal bone level alterations assessed on peri-apical radiographs using software (ImageJ)
Description
measured from a reference point (implant shoulder) to the most coronal point of BIC, both mesially and distally
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
> 18 years,
in need of a solitary implant in quadrant 1 and 2 or quadrant 3 and 4 with simultaneous GBR procedure
presence of a pre-operative CBCT.
Exclusion Criteria:
smokers
patients with systemic diseases that could interfere with the healing
patients undergoing bisphosphonate treatment
patients who previously received radiation therapy of the jaws
patients that received a GBR procedure in the region of interest in the past.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andy Temmerman, DDS, MSc, PhD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31602699
Citation
Temmerman A, Cortellini S, Van Dessel J, De Greef A, Jacobs R, Dhondt R, Teughels W, Quirynen M. Bovine-derived xenograft in combination with autogenous bone chips versus xenograft alone for the augmentation of bony dehiscences around oral implants: A randomized, controlled, split-mouth clinical trial. J Clin Periodontol. 2020 Jan;47(1):110-119. doi: 10.1111/jcpe.13209. Epub 2019 Nov 5.
Results Reference
derived
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GBR and Autogenous Bone Chips
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