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Horizontal Augmentation With Deproteinized Bovine Bone Mineral Alone or in Combination With Particulate Autogenous Bone

Primary Purpose

Edentulous Jaw

Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Lateral ridge augmentation
Sponsored by
NU-Hospital Organization, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Edentulous Jaw focused on measuring Bone substitutes, Imaging-Three-Dimensional, alveolar ridge augmentation, dental implants, Bio-Oss, Guided bone regeneration

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Total or partial bilateral edentulism
  • Horizontal bone width less than 4 mm at planned sites of implant installation or need of augmentation of aesthetic reasons for optimal implant placement

Exclusion Criteria:

  • Uncontrolled systematic disease
  • History of radiation in the area
  • Smoking habits (free of smoking habits more than 1 month prior to treatment)
  • Treatment with bisphosphonates
  • Patients who cannot complete the 5-year observation period

Sites / Locations

  • NU Hospital Organization

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

100:0

90:10

Arm Description

100 % bone substitute, 0% autogenous bone

90% bone substitute, 10% autogenous bone

Outcomes

Primary Outcome Measures

Newly formed bone
Amount of newly formed bone in the graft assessed by histological measurements
Height in mm
Height of the augmented area assessed by radiological measurements
Volume in mm3
Volume of the augmented area assessed by clinical and radiological measurements
Implant survival
Survival of implants placed in the graft assessed by clinical and radiological measurements
Implant survival
Survival of implants placed in the graft assessed by clinical and radiological measurements
Implant survival
Survival of implants placed in the graft assessed by clinical and radiological measurements

Secondary Outcome Measures

Full Information

First Posted
February 7, 2021
Last Updated
April 5, 2022
Sponsor
NU-Hospital Organization, Sweden
Collaborators
Aalborg University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04755166
Brief Title
Horizontal Augmentation With Deproteinized Bovine Bone Mineral Alone or in Combination With Particulate Autogenous Bone
Official Title
Lateral Ridge Augmentation With Two Different Compositions of Deproteinized Bovine Bone and Autogenous Bone: A Randomized, Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NU-Hospital Organization, Sweden
Collaborators
Aalborg University Hospital

4. Oversight

5. Study Description

Brief Summary
Background: Placement of oral implants is frequently compromised due to atrophy of the alveolar process. Lateral ridge augmentation with an autogenous bone block is frequently necessary to increase the width of the alveolar process before implant installation. However, harvesting of an autogenous bone block is associated with donor site morbidity. Consequently, bone substitutes alone or in combination with particulate autogenous bone graft are used increasingly to simplify the surgical procedure. Animal and human studies evaluating lateral ridge augmentation with Bio-Oss alone or in combination with particulate autogenous bone graft have demonstrated new bone formation and high implant survival. However, the optimal ratio of Bio-Oss and particulate autogenous bone graft for lateral ridge augmentation and long-term implant survival is unknown. Purpose: Test the H0-hypothesis of no difference in long-term implant survival, newly formed bone, volumetric stability of the graft, gained width of the alveolar process and patient satisfaction after lateral ridge augmentation with Bio-Oss alone or in combination with a diminutive amount of autogenous bone graft. Material and methods: lateral ridge augmentation will be performed in 20 adults with two different ratios of Bio-Oss and autogenous bone graft after a split mouth design. Clinical and radiological measurements will evaluate the long-term implant survival. Cone beam computer tomography (CBCT) will be obtained preoperatively, immediately postoperatively, prior to implant placement, 2 years after implant installation and 5 years after implant installation to estimate the volumetric changes of the augmented area. Moreover, the amount of newly formed bone will be estimated by histologic evaluation after implant placement. Conclusion: Long-term implant survival has never been evaluated after lateral ridge augmentation with Bio-Oss alone or in combination with a diminutive amount of autogenous bone graft.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Jaw
Keywords
Bone substitutes, Imaging-Three-Dimensional, alveolar ridge augmentation, dental implants, Bio-Oss, Guided bone regeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
100:0
Arm Type
Experimental
Arm Description
100 % bone substitute, 0% autogenous bone
Arm Title
90:10
Arm Type
Experimental
Arm Description
90% bone substitute, 10% autogenous bone
Intervention Type
Procedure
Intervention Name(s)
Lateral ridge augmentation
Primary Outcome Measure Information:
Title
Newly formed bone
Description
Amount of newly formed bone in the graft assessed by histological measurements
Time Frame
10 months after treatment
Title
Height in mm
Description
Height of the augmented area assessed by radiological measurements
Time Frame
10 months after treatment
Title
Volume in mm3
Description
Volume of the augmented area assessed by clinical and radiological measurements
Time Frame
10 months after treatment
Title
Implant survival
Description
Survival of implants placed in the graft assessed by clinical and radiological measurements
Time Frame
1 year after placement of the implants
Title
Implant survival
Description
Survival of implants placed in the graft assessed by clinical and radiological measurements
Time Frame
3 year after placement of the implants
Title
Implant survival
Description
Survival of implants placed in the graft assessed by clinical and radiological measurements
Time Frame
5 year after placement of the implants

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Total or partial bilateral edentulism Horizontal bone width less than 4 mm at planned sites of implant installation or need of augmentation of aesthetic reasons for optimal implant placement Exclusion Criteria: Uncontrolled systematic disease History of radiation in the area Smoking habits (free of smoking habits more than 1 month prior to treatment) Treatment with bisphosphonates Patients who cannot complete the 5-year observation period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanna Aludden, DDS, PhD
Organizational Affiliation
NU Hospital Organisation, Trollhättan, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
NU Hospital Organization
City
Trollhättan
ZIP/Postal Code
46273
Country
Sweden

12. IPD Sharing Statement

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Horizontal Augmentation With Deproteinized Bovine Bone Mineral Alone or in Combination With Particulate Autogenous Bone

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