Trials Sponsors Conditions Drugs Pricing

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.

Conditions

Edentulous Jaw

Keywords

Bone substitutesImaging-Three-Dimensionalalveolar ridge augmentationdental implantsBio-OssGuided bone regeneration

Outcome Measures

Primary Outcomes (6)

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

Study Arms (2)

100:0

EXPERIMENTAL

100 % bone substitute, 0% autogenous bone

Procedure: Lateral ridge augmentation

90:10

EXPERIMENTAL

90% bone substitute, 10% autogenous bone

Procedure: Lateral ridge augmentation

Interventions

Lateral ridge augmentationProcedure

100:090:10

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

Sponsors & Collaborators

NU-Hospital Organization, Sweden
Otherlead
Aalborg University Hospital
Othercollaborator

Study Sites (1)

NU Hospital Organization

Trollhättan, 46273, Sweden

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Study Officials

Hanna Aludden, DDS, PhD
NU Hospital Organisation, Trollhättan, Sweden
PRINCIPAL INVESTIGATOR

Enrollment

20 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

February 7, 2021

First Posted

February 15, 2021

Study Start

June 1, 2016

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (6)

Study Arms (2)

100:0

90:10

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

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

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (6)

Study Arms (2)

100:0

90:10

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations