Clinical trial NCT04755166: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Edentulous Jaw
Keywords: Bone substitutes
Imaging-Three-Dimensional
alveolar ridge augmentation
dental implants
Bio-Oss
Guided bone regeneration
Lead sponsor: NU-Hospital Organization, Sweden
Sponsor class: OTHER
Collaborators: name: Aalborg University Hospital
First posted: 2021-02-15
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Newly formed bone
timeFrame: 10 months after treatment
measure: Height in mm
timeFrame: 10 months after treatment
measure: Volume in mm3
timeFrame: 10 months after treatment
measure: Implant survival
timeFrame: 1 year after placement of the implants
measure: Implant survival
timeFrame: 3 year after placement of the implants
measure: Implant survival
timeFrame: 5 year after placement of the implants
Secondary outcomes:
Other outcomes:
Locations:
city: Trollhättan
country: Sweden
facility: NU Hospital Organization
Study officials:
affiliation: NU Hospital Organisation, Trollhättan, Sweden
name: Hanna Aludden, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: