Guided Bone RegenerationNCT06286605
RCT GBR One Stages Comparing A-Oss and Autogenous Bone Versus A-Oss and LCR-A
A study testing A-oss and autogenous bone and A-oss an LCR-A in people with Guided Bone Regeneration and Dental Implant, run by Università degli Studi di Sassari at 1 site in Italy.
Trial summary
The aim of this randomized controlled trial is to evaluate the tridimensional bone stability after horizontal one-stage GBR using collagene membrane (OssMem) with a mix of Bovine Bone Substitute (A-Oss) and autogenous bone (test group) versus A-Oss and LCR-A, a synthetic bone (control group). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Guided Bone Regeneration, Dental Implant
- What is being tested?
- A-oss and autogenous bone and A-oss an LCR-A
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2024to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients that required an implant supported restoration and staged horizontal guided bone regeneration (defect of class IV according to Cawed and Howell) in both mandible or maxilla.
- Patents able to understand and sign an informed consent.
- Patients were to be 18 years or older with a residual horizontal ridge thickness of 4 mm or less (Cawood-Howell Class III- IV) in the intended implant site.
- Smokers will be categorized into: 1) non smokers; 2) moderate smokers (smoking up to 10 cigarettes/day); 3) heavy smokers (smoking more than 11 cigarettes/day). Only categories 1 and 2 will be included.
Who cannot join
- General contraindications to implant surgery.
- Patients irradiated in the head and neck area.
- Immunosuppressed or immunocompromised patients.
- Patients treated or under treatment with intravenous amino-bisphosphonates.
- Patients with untreated periodontitis.
- Patients with poor oral hygiene and motivation.
Show all 16Show fewer
- Uncontrolled diabetes.
- Pregnancy or nursing.
- Substance abuser.
- Heavy smokers (smoking more than 11 cigarettes/day).
- Psychiatric problems or unrealistic expectations.
- Lack of opposite occluding dentition in the area intended for implant placement.
- Immediate implants (extractive sites will have to be healed from 6-8 weeks).
- Patients participating in other studies, if the present protocol cannot be properly adhered to.
- Patients referred only for implant placement and cannot be followed ant the treating centre.
- Patients unable to be followed for 5 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Marco Tallarico
Sassari, 07100
Dario Melodia, Dr, 3331226618, dariomld1@gmail.com
Marco Tallarico, Prof, 3280758769, me@studiomarcotallarico.it
About this study
Official title: Horizontal Ridge Augmentation Using One-stage Guided Bone Regeneration (GBR) for Bone Defect Class IV of Cawed and Howell With Collagene Membrane (OssMem) and a Mix of Bovine Bone Substitute (A-Oss) and Autogenous Bone Versus A-Oss and LCR-A, a Synthetic Bone : a Randomized Controlled Trial
The aim of this randomized controlled trial is to evaluate the tridimensional bone stability after horizontal one-stage GBR using collagene membrane (OssMem) with a mix of Bovine Bone Substitute (A-Oss) and autogenous bone (test group) versus A-Oss and LCR-A, a synthetic bone (control group).
- Conditions
- Guided Bone Regeneration, Dental Implant
- Being tested
- A-oss and autogenous bone, A-oss an LCR-A
- Keywords
- Dental Implant, GBR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A-oss and autogenous boneProcedure or surgery
Horizontal ridge augmentation in one stages approach will be performed using a mix of A-Oss and autologenous bone.
A-oss an LCR-AProcedure or surgery
Horizontal ridge augmentation in one stages approach will be performed using OssMem with A-Oss and LCR-A
| Study group | Role | What they receive |
|---|---|---|
| A-oss and autogenous bone | Experimental | In these group a GBR will be performed using only A-oss and autologous bone will be added and then will be covered with a membrane. Receives: Procedure: A-oss and autogenous bone |
| A-oss and LCR-A | Active comparator | In these subjects a GBR will be performed using only A-oss and LCR-A and then will be covered with a membrane. Receives: Procedure: A-oss an LCR-A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Implants survival
Defined as implant mobility and/or any infection dictating implant removal, and/or implant fracture and/or any other mechanical complication rendering the implant unusable. The stability of each individual implant will be measured by the local blinded outcome assessors manually tightening the screws with a torque of 30 Ncm at abutment connection at initial loading. At 1,3 and 5 years after loading, individual implants will be manually tested for stability. Once the single crowns will be screwed, their stability will be assessed by rocking the crown with the handles of two dental instruments
Measured: Up to 5 years
Number of Participants with prosthesis failure
Whether it will not be possible to place the prosthesis because of implant failure or a prosthesis that has to be remade for any reason.
Measured: Up to 5 years
Number of complications
Technical (fracture of the framework and/or the veneering material, screw loosening, etc.) and/or biologic (pain, swelling, mobility, membrane exposure, suppuration) complications will be considered
Measured: Up to 5 years
Secondary outcomes (6)
Horizontal and volumetric dimensional changes
CBCT scans will perform before ridge reconstruction and six months after. The Digital Imaging and Communication in Medicine (DICOM) data will export the OnDemand 3D software version 1.0.9.3223 (Cybermed Inc., Seoul, Korea) to perform all measurements. The DICOM data were manually alined basic on unchanged anatomical areas (e.g., teeth, basal skull, implants) and then automatically matched using the Fusion adjunctive module (Cybermed Inc. Seoul, Korea). Horizontal bone measure will recorded for all reconstructed ridge 2 mm below the bone crest, before and after treatment. Then, the postoperative volumetric data were subtracted to the original scenario. The new generated set of DICOM data will stored as a separately files. Volumetric measurements of grafts were performed with OnDemand 3D software (Cybermed Inc., Seoul, Korea) using the previously generated set of DICOM data.The volumes of the grafted material will calculated using automatic tools, basing on its opacity.
Measured: 6 and 12 months
Rate of peri-implant marginal bone level
Peri-implant marginal bone level changes will be assessed on periapical radiographs took with the paralleling technique at implant placement, at initial loading, 1,3 and 5 years after loading. Ideally digital radiographs should be taken, otherwise radiographs on conventional films will be scanned into TIFF format with a 600 dpi resolution, and stored in a personal computer. Peri-implant marginal bone levels will be measured using the Scion Image (Scion Corporation, Frederick, MD, USA) software. The software will be calibrated for every single image using the known distance of the first two consecutive threads. Measurements of the mesial and distal bone crest level adjacent to each implant will be made to the nearest 0.01 mm. Reference points for the linear measurements will be: the coronal margin of the implant collar and the most coronal point of bone-to-implant contact. Bone levels will be measured.
Measured: At 1,3 and 5 years
Plaque Index and bleeping on probing
Plaque index (PI), defined as plaque absent or present (0/1), and Bleeding on Probing (BoP), defined as bleeding on probing absent or present (0/1), will recorded 1,3 and 5 years after final prosthesis delivery. One assessor, not previously involved in the study, made all the clinical outcomes.
Measured: At 1,3 and 5 years
Valuation of patient satisfaction
Patients will answer the following questions (separately for each implant):
- Are you satisfied with the function of your implant-supported prostheses? Possible answers: yes absolutely, yes partly, not sure, not really, absolutely not.
- Are you satisfied with the aesthetic outcome of your implant-supported prostheses? Possible answers: yes absolutely, yes partly, not sure, not really, absolutely not.
- Would you undergo the same therapy again? Possible answers: "yes" or "no".1) Are you satisfied with the function of your implant-supported prostheses? Possible answers: yes absolutely, yes partly, not sure, not really, absolutely not.
- Are you satisfied with the aesthetic outcome of your implant-supported prostheses? Possible answers: yes absolutely, yes partly, not sure, not really, absolutely not.
- Would you undergo the same therapy again? Possible answers: "yes" or "no".
Measured: At 1,3 and 5 years
Valuation of soft tissue thickness and amount of keratinized tissue
The soft tissue biotype will be investigated by the same surgeon at the surgical procedures using a periodontal probe into the sulcus. Greater will be the thickness of the tissue, smaller will be transparency of the periodontal probe. The amount of keratinized tissue will be evaluated 1 year after surgical procedures using a periodontal probe. This outcome will be evaluated according to the distance from the gingival margin to the mucogingival junction
Measured: At 1,3 and 5 years
Rate of pes score
Esthetic evaluation of occlusal and vestibular pictures will take every years after definite loading was done following the pink esthetic score (PES). In brief, the PES score evaluates seven variables: mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar process deficiencies, soft tissue color and texture. A 0-1-2 scoring system was used, 0 being the lowest and 2 being the highest value, with a maximum achievable score of 14 per dental unit.
Measured: At 1,3 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Guided Bone RegenerationStudies 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
- Model description
- Multicenter, randomized controlled trial of parallel-group design.
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Sassari
- Sponsor type
- University, hospital or other
- Collaborators
- Melodia, Dario, M.D., Pisano, Milena, M.D., Dr. Aurea Lumbau, Meloni, Silvio Mario, M.D., Baldoni, Edoardo, M.D.
- Responsible party
- Principal investigator, Marco Tallarico, Università degli Studi di Sassari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286605
- Sponsor's protocol ID
- UNISS_PHD_Osstem_4
- Status last verified
- Feb 2024
- First submitted
- 24 Apr 2023
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Horizontal Ridge Augmentation Using One-stage Guided Bone Regeneration (GBR) for Bone Defect Class IV of Cawed and Howell With Collagene Membrane (OssMem) and a Mix of Bovine Bone Substitute (A-Oss) and Autogenous Bone Versus A-Oss and LCR-A, a Synthetic Bone : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06286605
- Acronym / sponsor ID
- UNISS_PHD_Osstem_4
- Conditions
- Guided Bone Regeneration, Dental Implant
- Keywords
- Dental Implant, GBR
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Università degli Studi di SassariUniversity, hospital or other
- Collaborators
- Melodia, Dario, M.D., Pisano, Milena, M.D., Dr. Aurea Lumbau, Meloni, Silvio Mario, M.D., Baldoni, Edoardo, M.D.
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 29 Feb 2024 (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.
The aim of this randomized controlled trial is to evaluate the tridimensional bone stability after horizontal one-stage GBR using collagene membrane (OssMem) with a mix of Bovine Bone Substitute (A-Oss) and autogenous bone (test group) versus A-Oss and LCR-A, a synthetic bone (control group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, randomized controlled trial of parallel-group design.
| Arm | Type | Receives |
|---|---|---|
| A-oss and autogenous bone | Experimental | Procedure: A-oss and autogenous boneIn these group a GBR will be performed using only A-oss and autologous bone will be added and then will be covered with a membrane. |
| A-oss and LCR-A | Active comparator | Procedure: A-oss an LCR-AIn these subjects a GBR will be performed using only A-oss and LCR-A and then will be covered with a membrane. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients that required an implant supported restoration and staged horizontal guided bone regeneration (defect of class IV according to Cawed and Howell) in both mandible or maxilla.
- Patents able to understand and sign an informed consent.
- Patients were to be 18 years or older with a residual horizontal ridge thickness of 4 mm or less (Cawood-Howell Class III- IV) in the intended implant site.
- Smokers will be categorized into: 1) non smokers; 2) moderate smokers (smoking up to 10 cigarettes/day); 3) heavy smokers (smoking more than 11 cigarettes/day). Only categories 1 and 2 will be included.
Key exclusion criteria (16 listed)
- General contraindications to implant surgery.
- Patients irradiated in the head and neck area.
- Immunosuppressed or immunocompromised patients.
- Patients treated or under treatment with intravenous amino-bisphosphonates.
- Patients with untreated periodontitis.
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 |
|---|---|---|
| A-oss and autogenous boneHorizontal ridge augmentation in one stages approach will be performed using a mix of A-Oss and autologenous bone. | Procedure or surgery | A-oss and autogenous bone |
| A-oss an LCR-AHorizontal ridge augmentation in one stages approach will be performed using OssMem with A-Oss and LCR-A | Procedure or surgery | A-oss and LCR-A |
Primary outcome
Rate of Implants survival
Time frame: Up to 5 years
Defined as implant mobility and/or any infection dictating implant removal, and/or implant fracture and/or any other mechanical complication rendering the implant unusable. The stability of each individual implant will be measured by the local blinded outcome assessors manually tightening the screws with a torque of 30 Ncm at abutment connection at initial loading. At 1,3 and 5 years after loading, individual implants will be manually tested for stability. Once the single crowns will be screwed, their stability will be assessed by rocking the crown with the handles of two dental instruments
Number of Participants with prosthesis failure
Time frame: Up to 5 years
Whether it will not be possible to place the prosthesis because of implant failure or a prosthesis that has to be remade for any reason.
Number of complications
Time frame: Up to 5 years
Technical (fracture of the framework and/or the veneering material, screw loosening, etc.) and/or biologic (pain, swelling, mobility, membrane exposure, suppuration) complications will be considered
6 secondary outcomes
Horizontal and volumetric dimensional changes
Time frame: 6 and 12 months
Rate of peri-implant marginal bone level
Time frame: At 1,3 and 5 years
Plaque Index and bleeping on probing
Time frame: At 1,3 and 5 years
Valuation of patient satisfaction
Time frame: At 1,3 and 5 years
Valuation of soft tissue thickness and amount of keratinized tissue
Time frame: At 1,3 and 5 years
Rate of pes score
Time frame: At 1,3 and 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Guided Bone Regeneration
Active, not recruitingObservational study
Long-Term Stability of Soft and Hard Tissues After Guided Bone Regeneration in the Maxillary Anterior Region
Alveolar Bone Deficiency
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Guided Bone Regeneration Using Polydioxanone (PDO) Membrane in Sockets After Tooth Extraction
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Comparison of Three Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
Not yet recruitingPhase 1/2
Alveolar Ridge Preservation (ARP) Study Using Alloplastic Biomaterial and a Resorbable Synthetic Membrane. A Digital Workflow (CBCT/Scanner) Evaluates Hard and Soft Tissue Volumetric Changes at 4 Months, Validating Support for the Gingival Phenotype and Buccal Bone Plate.
Alveolar Ridge Augmentation, Bone Substitutes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A-oss and autogenous bone and A-oss an LCR-A in people with Guided Bone Regeneration and Dental Implant, run by Università degli Studi di Sassari at 1 site in Italy.
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 4 inclusion and 16 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: opening soon, as of the sponsor's last update on 29 Feb 2024. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Implants survival (time frame: Up to 5 years). The study lists 3 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 29 Feb 2024.