GBR and Autogenous Bone Chips

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Bone Resorption

Intervention / Treatment
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* Procedure: Guided bone regeneration with or without autologous bone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Split mouth
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Augmentation with autologous bone + DBBM<br>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<br>* 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.<br>|
| Experimental: Augmentation with DBBM<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Horizontal and vertical bone augmentation | The change of dimension was assessed comparing Cone Beam Computed Tomography scans (CBCT) | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 year | 
| 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 | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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implants; GBR; DBBM; grafts; bone