Edentulous JawNCT04755166
Horizontal Augmentation With Deproteinized Bovine Bone Mineral Alone or in Combination With Particulate Autogenous Bone
A study testing Lateral ridge augmentation in people with Edentulous Jaw, run by NU-Hospital Organization, Sweden at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Edentulous Jaw
- What is being tested?
- Lateral ridge augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jun 2016to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Lateral ridge augmentation
- Keywords
- Bone substitutes, Imaging-Three-Dimensional, alveolar ridge augmentation, dental implants, Bio-Oss, Guided bone regeneration
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral ridge augmentationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 100:0 | Experimental | 100 % bone substitute, 0% autogenous bone Receives: Procedure: Lateral ridge augmentation |
| 90:10 | Experimental | 90% bone substitute, 10% autogenous bone Receives: Procedure: Lateral ridge augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Newly formed bone
Amount of newly formed bone in the graft assessed by histological measurements
Measured: 10 months after treatment
Height in mm
Height of the augmented area assessed by radiological measurements
Measured: 10 months after treatment
Volume in mm3
Volume of the augmented area assessed by clinical and radiological measurements
Measured: 10 months after treatment
Implant survival
Survival of implants placed in the graft assessed by clinical and radiological measurements
Measured: 1 year after placement of the implants
Implant survival
Survival of implants placed in the graft assessed by clinical and radiological measurements
Measured: 3 year after placement of the implants
Implant survival
Survival of implants placed in the graft assessed by clinical and radiological measurements
Measured: 5 year after placement of the implants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start1 Jun 2016
- Primary completion1 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous JawStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- NU-Hospital Organization, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital
- Responsible party
- Principal investigator, Hanna Aludden, NU-Hospital Organization, Sweden
- Investigators
- Hanna Aludden, DDS, PhD, Principal investigator, NU Hospital Organisation, Trollhättan, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755166
- Sponsor's protocol ID
- LRA humans
- Status last verified
- Apr 2022
- First submitted
- 7 Feb 2021
- Last updated
- 6 Apr 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Ridge Augmentation With Two Different Compositions of Deproteinized Bovine Bone and Autogenous Bone: A Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT04755166
- Acronym / sponsor ID
- LRA humans
- Conditions
- Edentulous Jaw
- Keywords
- Bone substitutes, Imaging-Three-Dimensional, alveolar ridge augmentation, dental implants, Bio-Oss, Guided bone regeneration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- NU-Hospital Organization, SwedenUniversity, hospital or other
- Collaborators
- Aalborg University Hospital
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 100:0 | Experimental | Procedure: Lateral ridge augmentation100 % bone substitute, 0% autogenous bone |
| 90:10 | Experimental | Procedure: Lateral ridge augmentation90% bone substitute, 10% autogenous bone |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lateral ridge augmentation | Procedure or surgery | 100:0, 90:10 |
Primary outcome
Newly formed bone
Time frame: 10 months after treatment
Amount of newly formed bone in the graft assessed by histological measurements
Height in mm
Time frame: 10 months after treatment
Height of the augmented area assessed by radiological measurements
Volume in mm3
Time frame: 10 months after treatment
Volume of the augmented area assessed by clinical and radiological measurements
Implant survival
Time frame: 1 year after placement of the implants
Survival of implants placed in the graft assessed by clinical and radiological measurements
Implant survival
Time frame: 3 year after placement of the implants
Survival of implants placed in the graft assessed by clinical and radiological measurements
Implant survival
Time frame: 5 year after placement of the implants
Survival of implants placed in the graft assessed by clinical and radiological measurements
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanna Aludden, DDS, PhD principal investigator
NU Hospital Organisation, Trollhättan, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lateral ridge augmentation in people with Edentulous Jaw, run by NU-Hospital Organization, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Newly formed bone (time frame: 10 months after treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.