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

April 5, 2022 updated by: Hanna Aludden, NU-Hospital Organization, Sweden

Lateral Ridge Augmentation With Two Different Compositions of Deproteinized Bovine Bone and Autogenous Bone: A Randomized, Controlled Study

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Trollhättan, Sweden, 46273
        • NU Hospital Organization

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 100:0
100 % bone substitute, 0% autogenous bone
Procedure: Lateral ridge augmentation
Experimental: 90:10
90% bone substitute, 10% autogenous bone
Procedure: Lateral ridge augmentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Newly formed bone
Time Frame: 10 months after treatment
Amount of newly formed bone in the graft assessed by histological measurements
10 months after treatment
Height in mm
Time Frame: 10 months after treatment
Height of the augmented area assessed by radiological measurements
10 months after treatment
Volume in mm3
Time Frame: 10 months after treatment
Volume of the augmented area assessed by clinical and radiological measurements
10 months after treatment
Implant survival
Time Frame: 1 year after placement of the implants
Survival of implants placed in the graft assessed by clinical and radiological measurements
1 year after placement of the implants
Implant survival
Time Frame: 3 year after placement of the implants
Survival of implants placed in the graft assessed by clinical and radiological measurements
3 year after placement of the implants
Implant survival
Time Frame: 5 year after placement of the implants
Survival of implants placed in the graft assessed by clinical and radiological measurements
5 year after placement of the implants

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NU-Hospital Organization, Sweden

Collaborators

Aalborg University Hospital

Investigators

  • Principal Investigator: Hanna Aludden, DDS, PhD, NU Hospital Organisation, Trollhättan, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

February 7, 2021

First Submitted That Met QC Criteria

February 11, 2021

First Posted (Actual)

February 15, 2021

Study Record Updates

Last Update Posted (Actual)

April 6, 2022

Last Update Submitted That Met QC Criteria

April 5, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LRA humans

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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