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GBR and Autogenous Bone Chips

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ClinicalTrials.gov Identifier: NCT03946020
Recruitment Status : Completed
First Posted : May 10, 2019
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Wim Teughels, Universitaire Ziekenhuizen Leuven

Study Description
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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


Condition or disease Intervention/treatment Phase
Bone Resorption Procedure: Guided bone regeneration with or without autologous bone Not Applicable

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Split mouth
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 1, 2013
Actual Primary Completion Date : February 1, 2019
Actual Study Completion Date : February 1, 2019
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Augmentation with autologous bone + DBBM
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.
 Procedure: Guided bone regeneration with or without autologous bone
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.
Experimental: Augmentation with DBBM
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.
 Procedure: Guided bone regeneration with or without autologous bone
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.


Outcome Measures
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Primary Outcome Measures :
  1. Horizontal and vertical bone augmentation [ Time Frame: 16 weeks ]
    The change of dimension was assessed comparing Cone Beam Computed Tomography scans (CBCT)


Secondary Outcome Measures :
  1. Success of grafting procedure as assessed by clinical interpretation [ Time Frame: 1 year ]
    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

  2. Marginal bone level alterations assessed on peri-apical radiographs using software (ImageJ) [ Time Frame: 1 year ]
    measured from a reference point (implant shoulder) to the most coronal point of BIC, both mesially and distally


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03946020


Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Andy Temmerman, DDS, MSc, PhD Universitaire Ziekenhuizen Leuven
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Wim Teughels, Clinical Professor, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03946020    
Other Study ID Numbers: S55609
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wim Teughels, Universitaire Ziekenhuizen Leuven:
implants; GBR; DBBM; grafts; bone
Additional relevant MeSH terms:
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Bone Resorption
Bone Diseases
Musculoskeletal Diseases