Horizontal Bone AugmentationNCT03028922
A 1-year Clinical Investigation on the the CREOS™ XENOGAIN Bone Graft SUBSTITUTE
A study testing creos xenogain in people with Horizontal Bone Augmentation, run by Nobel Biocare at 6 sites in 3 countries.
Trial summary
This clinical investigation is a prospective, multi-centre study to evaluate bone gain after horizontal augmentation using creos xenogain bone graft substitute. Patients included in the study are in need of a GBR procedure prior to implant placement in the premolar and posterior region of the mandible. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Horizontal Bone Augmentation
- What is being tested?
- creos xenogain
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Oct 2016to Jun 2020
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects between 18 and 80 years old.
- Patient has signed informed consent to participate in the study.
- Patients in need of horizontal ridge augmentation prior to implant placement in the premolar and posterior region of the mandible
- Horizontal defect classified as: Horizontal medium defect (Hm) (4-6 mm defect) or Horizontal large defect (Hl) (≥7 mm defect)
- Patients presented with a combination defect Horizontal/Vertical with a maximum of 2mm loss of vertical dimensions (minimal vertical dimension for patient inclusion is 7.5 mm defined as the distance from the anatomical landmark, alveolar nerve or lingual dehiscence)
- The subject must be in good physical and mental condition
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- The subject is willing and able to comply with all study related procedures (such as exercising oral hygiene and attending all follow-up procedures).
- Full-mouth bleeding score (FMBS) lower than 25%.
- Full-mouth plaque score (FMPI) lower than 25%.
- The subject is suitable for a 2-stage surgical procedure
Who cannot join
- Severe bone defect classified as: Vertical medium (Vm) (4-6 mm defect) or Vertical large, (Vl) (≥7 mm)
- Medium (Cm) and Large (Cl) classified combination defects Prior bone augmentation in the area planned for treatment (i.e ridge preservation)
- Health conditions, which do not permit the surgical (including anesthesia) or restorative procedure.
- Any disorders directly in the planned implant area such as previous tumors, chronic bone disease.
- Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc).
- Alcohol or drug abuse as noted in subject records or in subject history.
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- Reason to believe that the treatment might have a negative effect on the subject's overall situation (psychiatric problems), as noted in subject records or history.
- Heavy smoking (> 10 cigarettes per day).
- Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of neglecting doctor's recommendations regarding treatment, food and alcohol intake or A1c level above 8%.
- Poor compliance.
- Active periodontal disease involving the residual dentition.
- Mucosal diseases in the areas to be treated.
- Pregnant or lactating women at the time of bone augmentation procedure.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Germany2 sites
Praxisklinik der Zahnheilkunde am Luisenhospital
Aachen, 52064
Universitäts Klinikum Frankfurt
Frankfurt, 60596
Italy2 sites
Clinica Odontoiatrica - Dipartimento di Neuroscienze, Università di Padova
Padua, 35128
Clinica Merli
Rimini, 47923
Serbia2 sites
Military Academy of Belgrade, Oral Surgery
Belgrade, 11 000
University of Belgrade, Periodontology
Belgrade, 11000
About this study
Official title: A Prospective, Multi-centre Study Evaluating Creos™ Xenogain Bone Graft Substitute in Horizontal Ridge Augmentation in the Premolar and Molar Region of the Mandible
This clinical investigation is a prospective, multi-centre study to evaluate bone gain after horizontal augmentation using creos xenogain bone graft substitute. Patients included in the study are in need of a GBR procedure prior to implant placement in the premolar and posterior region of the mandible.
Read the detailed description
This clinical investigation is a prospective, multi-centre study to evaluate bone gain after horizontal augmentation using creos xenogain bone graft substitute.
Patients included in the study are in need of a GBR procedure prior to implant placement in the premolar and posterior region of the mandible.
Primary endpoint include the bone gain after 8 months healing period, while secondary endpoints includes histological analysis 8 months after performance of the augmentation procedure as well as Implant survival, implant success and marginal bone levels evaluated over a period of 1 year after definitive prosthetic delivery.
- Conditions
- Horizontal Bone Augmentation
- Being tested
- creos xenogain
- Keywords
- creos xenogain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
creos xenogainDevice
GBR procedure will be performed using creors xenogain bone graft substitute in patients that need horizontal bone augmentation prior to implant placement. The defect should be located in the pre-molar and molar region of the mandible
| Study group | Role | What they receive |
|---|---|---|
| creos xenogain | Other | Patients in need of bone augmentation prior to implant insertion will undergo GBR procedure using Creos xenogain bone graft substitute Receives: Device: creos xenogain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone gain 8 months after bone augmentation procedure for implant placement.
To evaluate bone gain 8 months after bone augmentation procedure for implant placement.
Measured: 8 months
Secondary outcomes (6)
Implant survival
To demonstrate cumulative survival rate of the implants placed in the augmented bone at 6 months and at 1 year after definitive prosthetic delivery.
Measured: 6 months and 1 year after definitive prosthetic delivery
Implant success
To demonstrate cumulative success rate of the implants placed in the augmented bone at 6 months and 1 year after definitive prosthetic delivery.
Measured: 6 months and 1 year after definitive prosthetic delivery
Marginal bone levels
To demonstrate the changes in marginal bone levels (ΔMBL) around the implants placed in the augmented bone as measured and evaluated by periapical films, 6 months and 1 year after definitive prosthetic delivery
Measured: 6 months and 1 year after definitive prosthetic delivery
Histological analysis prior to implant insertion including percentage of vital bone, residual graft and connective tissue or other non bone components
A bone sample using a trephine bur will be collected after 8 months and prior to implant insertion in order to perform histological analysis. The analysis will include the following parameters: percentage of vital bone and residual graft and connective tissue and if present other non bone components
Measured: 8 months
Soft tissue outcome 1 year after definitive prosthetic delivery
Soft tissue outcome is a combination of different parameters that include gingival index, bleeding index, keratinized mucosa and pink esthetic score
Measured: 1 year
oral health related quality of life assessment
To demonstrate pre- and postoperatively the oral health related quality of life assessment using the Oral Health Impact Profile questionnaire (OHIP-14).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study startOct 2016
- Primary completionApr 2018
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Horizontal Bone AugmentationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nobel Biocare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028922
- Sponsor's protocol ID
- T-189
- Status last verified
- Mar 2020
- First submitted
- 10 Jan 2017
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Lorenz J, Ghanaati S, Aleksic Z, Milinkovic I, Lazic Z, Magic M, Wessing B, Grotenclos RS, Merli M, Mariotti G, Bressan E, De Stavola L, Sader R. Horizontal Guided Bone Regeneration of the Posterior Mandible to Allow Implant Placement: 1-Year Prospective Study Results. Clin Oral Implants Res. 2025 Jan;36(1):100-116. doi: 10.1111/clr.14363. Epub 2024 Oct 1.
PubMed 39351703
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-centre Study Evaluating Creos™ Xenogain Bone Graft Substitute in Horizontal Ridge Augmentation in the Premolar and Molar Region of the Mandible
- ClinicalTrials.gov ID
- NCT03028922
- Acronym / sponsor ID
- T-189
- Conditions
- Horizontal Bone Augmentation
- Keywords
- creos xenogain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Nobel BiocareIndustry (pharma, biotech, devices)
- Study start
- Oct 2016
- Primary completion
- Apr 2018 (actual)
- Study completion
- Jun 2020 (estimated)
- First posted
- 23 Jan 2017 (estimated)
- 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.
This clinical investigation is a prospective, multi-centre study to evaluate bone gain after horizontal augmentation using creos xenogain bone graft substitute. Patients included in the study are in need of a GBR procedure prior to implant placement in the premolar and posterior region of the mandible.
Detailed description
This clinical investigation is a prospective, multi-centre study to evaluate bone gain after horizontal augmentation using creos xenogain bone graft substitute.
Patients included in the study are in need of a GBR procedure prior to implant placement in the premolar and posterior region of the mandible.
Primary endpoint include the bone gain after 8 months healing period, while secondary endpoints includes histological analysis 8 months after performance of the augmentation procedure as well as Implant survival, implant success and marginal bone levels evaluated over a period of 1 year after definitive prosthetic delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| creos xenogain | Other | Device: creos xenogainPatients in need of bone augmentation prior to implant insertion will undergo GBR procedure using Creos xenogain bone graft substitute |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects between 18 and 80 years old.
- Patient has signed informed consent to participate in the study.
- Patients in need of horizontal ridge augmentation prior to implant placement in the premolar and posterior region of the mandible
- Horizontal defect classified as: Horizontal medium defect (Hm) (4-6 mm defect) or Horizontal large defect (Hl) (≥7 mm defect)
- Patients presented with a combination defect Horizontal/Vertical with a maximum of 2mm loss of vertical dimensions (minimal vertical dimension for patient inclusion is 7.5 mm defined as the distance from the anatomical landmark, alveolar nerve or lingual dehiscence)
Key exclusion criteria (13 listed)
- Severe bone defect classified as: Vertical medium (Vm) (4-6 mm defect) or Vertical large, (Vl) (≥7 mm)
- Medium (Cm) and Large (Cl) classified combination defects Prior bone augmentation in the area planned for treatment (i.e ridge preservation)
- Health conditions, which do not permit the surgical (including anesthesia) or restorative procedure.
- Any disorders directly in the planned implant area such as previous tumors, chronic bone disease.
- Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc).
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 |
|---|---|---|
| creos xenogainGBR procedure will be performed using creors xenogain bone graft substitute in patients that need horizontal bone augmentation prior to implant placement. The defect should be located in the pre-molar and molar region of the mandible | Device | creos xenogain |
Primary outcome
Bone gain 8 months after bone augmentation procedure for implant placement.
Time frame: 8 months
To evaluate bone gain 8 months after bone augmentation procedure for implant placement.
6 secondary outcomes
Implant survival
Time frame: 6 months and 1 year after definitive prosthetic delivery
Implant success
Time frame: 6 months and 1 year after definitive prosthetic delivery
Marginal bone levels
Time frame: 6 months and 1 year after definitive prosthetic delivery
Histological analysis prior to implant insertion including percentage of vital bone, residual graft and connective tissue or other non bone components
Time frame: 8 months
Soft tissue outcome 1 year after definitive prosthetic delivery
Time frame: 1 year
oral health related quality of life assessment
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Derived from this study: PubMed 39351703Lorenz J, Ghanaati S, Aleksic Z, Milinkovic I, Lazic Z, Magic M, Wessing B, Grotenclos RS, Merli M, Mariotti G, Bressan E, De Stavola L, Sader R. Horizontal Guided Bone Regeneration of the Posterior Mandible to Allow Implant Placement: 1-Year Prospective Study Results. Clin Oral Implants Res. 2025 Jan;36(1):100-116. doi: 10.1111/clr.14363. Epub 2024 Oct 1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing creos xenogain in people with Horizontal Bone Augmentation, run by Nobel Biocare at 6 sites in 3 countries.
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 10 inclusion and 13 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 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Italy, Serbia. 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?
Bone gain 8 months after bone augmentation procedure for implant placement. (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03028922, which also lists 1 linked publication.
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 18 Mar 2020.