The Presence of Horizontal and Vertical Alveolar Defects in Both Jaws, Inadequate for the Placement of at Least Two Fixtures, Even ≤6 mm Long OnesNCT04942223
Guided Bone Regeneration With Custom Made Meshes
A study testing guided bone regeneration in people with The Presence of Horizontal and Vertical Alveolar Defects in Both Jaws, Inadequate for the Placement of at Least Two Fixtures, Even ≤6 mm Long Ones, run by University of Bologna.
Trial summary
Twenty patients underwent a guided bone regenerative procedure with the application of a virtually projected customized mesh as containment and stabilizer of particulate bone graft. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- The Presence of Horizontal and Vertical Alveolar Defects in Both Jaws, Inadequate for the Placement of at Least Two Fixtures, Even ≤6 mm Long Ones
- What is being tested?
- guided bone regeneration
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 9 Apr 2013to 31 Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The presence of horizontal and vertical alveolar defects in both jaws, inadequate for the placement of at least two fixtures, even ≤6 mm long ones;
- ≥ 18 years;
- informed consent signed.
Who cannot join
- acute or chronic infections in the head and neck;
- smoking >10 cigarettes per day;
- uncontrolled diabetes (glycated hemoglobin level > 7 mg/dL);
- a history of radiation therapy in the head or neck region;
- current antitumor chemotherapy;
- liver, blood, or kidney disease;
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- immunosuppression;
- everyday corticosteroid use;
- pregnancy;
- inflammatory and autoimmune disease of the oral cavity;
- poor oral hygiene and motivation
About this study
Official title: Guided Bone Regeneration With Custom Made Meshes in the Dental Rehabilitation of Three Dimensional and Extended Defect of the Jaws.
Twenty patients underwent a guided bone regenerative procedure with the application of a virtually projected customized mesh as containment and stabilizer of particulate bone graft. The entity of bone volume reconstructed after healing were digitally analysed on radiological imaging and expressed in volumetric data and in percentage of what planned before the operation. This datum was correlated with predictors variables potentially affecting the final results. As secondary outcome the implant results after the prosthetic loading was evaluated in terms of survival, success and complication.
Read the detailed description
The implant-borne rehabilitation of three-dimensional and extended alveolar defects is not simple in any case: anatomic and prosthetic demands often require bone reconstructive procedures. Up to date, we can entirely virtually simulate our treatment .The design and printing of a customized mesh mimicking the ideal reconstruction eliminate the intra-operative handling and trimming, with reduced surgical timings and minimal stress for the soft tissues.
The aim is to verify if virtual planning with a customized scaffold could improve the predictability of a complex bone reconstruction in terms of bone reconstruction and implant results.
Twenty patients underwent a guided bone regenerative procedure with the application of a virtually projected customized mesh as containment and stabilizer of particulate bone graft. The entity of bone volume reconstructed after healing were digitally analysed on radiological imaging and expressed in volumetric data and in percentage of what planned before the operation. This datum was correlated with predictors variables potentially affecting the final result: six months at least after surgery, a new cone-beam CT was taken;the pre-and postoperative CT datasets were converted into three-dimensional models and digitally aligned; the reconstructed bone volumes (RBV) were calculated according to the planned bone volumes (PBVs), outlining the areas under the mesh. These values were correlated with complications, atrophies' location and the entity of virtually planned bone volume. As secondary outcome the implant results after the prosthetic loading was evaluated in terms of survival, success and complication.
- Being tested
- guided bone regeneration
- Keywords
- virtual planning, GBR, titanium meshes.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
guided bone regenerationDevice
Also called bone reconstruction
After local anesthesia, the surgery started with a mid-crestal incision with vertical releasing cuts followed by the full-thickness buccal and lingual/palatal flaps raising to expose the bone defect completely. The flaps were coronally extended to assure a complete closure with a passive suture above the titanium. Subsequently, an intra-oral mandibular ramus bone cortical block was harvested in the molar zone. The bone block was milled and mixed with freeze-dried. The particulate graft was put to fill the deficit above the mesh until its perfect stability and unity with the defect's borders. Two or three titanium mini-screws were used to stabilize the device , and the flaps were carefully sutured. Ceftriaxone was administered intravenously at a loading dose of 2 g; together with a non-steroidal analgesic, it was continued at two g/die per os beginning the day after surgery and continuing for six days.
| Study group | Role | What they receive |
|---|---|---|
| Subjects undergoing virtually planned GBR for extended and complex alveolar defects. | Other | Subjects undergoing virtually planned GBR for extended and complex alveolar defects.
The subjects were selected from the population of patients referring to the Oral \& Maxillofacial Surgery Unit of S.Orsola-Malpighi University Hospital for oral function rehabilitation. Eligibility criteria were: the presence of horizontal and vertical alveolar defects in both jaws, inadequate for the placement of at least two fixtures, even ≤6 mm long ones; ≥ 18 years; informed consent signed. Receives: Device: guided bone regeneration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone regeneration volumes
The bone reconstruction was calculated comparing the pre-operative and postoperative volumes. The Reconstructed Bone Volume (RBV) derived by subtracting the Lacking Bone Volume (LBV) values from Planned Bone Volume (PBV) ones. The pre-and postoperative CT datasets were converted into 3D models using Amira imaging software, version 5.3.3. The segmentation regarded almost the entire jaw structure to have at least six precise anatomical points of matching for the superimposition. After that, the pre and postoperative models were digitally aligned with Geomagic Studio 12 software. After the alignment was verified at a minimum range of tolerance of error level of ±0.37 mm in the areas no involved by the surgery, the measurements were performed. In every single slice, the space between the mesh profile and the basal bone was virtually selected and rendered to obtain the PBV; the area representative for the empty space according to the gray-scale of pixels was rendered for the LBV.
Measured: 6 months after surgery
Secondary outcomes (3)
Implant survival.
The number of implants in function at the end of follow-up was recorded
Measured: 1 year after implant loading at least.
Complication rate
The number of complications (peri-implantitis, infections, prosthetic fractures, soft tissue problems) was recorded and expressed in numerical data.
Measured: through study completion, an average of 2 years.
Implant success
The implant succes was calculated in respect to the bone resorption around each implant, radiographically assessed: with a dedicated software, the distance between the implant shoulder and the higher point of bone-implant contact was measured mesially and distally, attributing a mean value to each implant. These measures, expressed in millimeters, were recorded and reported as numerical data.
Measured: 1 year after implant loading at least.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start9 Apr 2013
- Primary completion15 May 2018
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Presence of Horizontal and Vertical Alveolar Defects in Both Jaws, Inadequate for the Placement of at Least Two Fixtures, Even ≤6 mm Long OnesStudies 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
- Model description
- prospective pilot cohort study
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Lizio, University of Bologna
- Investigators
- Giuseppe lizio, DDS, Principal investigator, University of Bologna (Italy) UNIBO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942223
- Sponsor's protocol ID
- 121/2013
- Status last verified
- Jun 2021
- First submitted
- 15 Jun 2021
- Last updated
- 28 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided Bone Regeneration With Custom Made Meshes in the Dental Rehabilitation of Three Dimensional and Extended Defect of the Jaws.
- ClinicalTrials.gov ID
- NCT04942223
- Acronym / sponsor ID
- 121/2013
- Keywords
- virtual planning, GBR, titanium meshes.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 9 Apr 2013 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 28 Jun 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.
Twenty patients underwent a guided bone regenerative procedure with the application of a virtually projected customized mesh as containment and stabilizer of particulate bone graft. The entity of bone volume reconstructed after healing were digitally analysed on radiological imaging and expressed in volumetric data and in percentage of what planned before the operation. This datum was correlated with predictors variables potentially affecting the final results. As secondary outcome the implant results after the prosthetic loading was evaluated in terms of survival, success and complication.
Detailed description
The implant-borne rehabilitation of three-dimensional and extended alveolar defects is not simple in any case: anatomic and prosthetic demands often require bone reconstructive procedures. Up to date, we can entirely virtually simulate our treatment .The design and printing of a customized mesh mimicking the ideal reconstruction eliminate the intra-operative handling and trimming, with reduced surgical timings and minimal stress for the soft tissues.
The aim is to verify if virtual planning with a customized scaffold could improve the predictability of a complex bone reconstruction in terms of bone reconstruction and implant results.
Twenty patients underwent a guided bone regenerative procedure with the application of a virtually projected customized mesh as containment and stabilizer of particulate bone graft. The entity of bone volume reconstructed after healing were digitally analysed on radiological imaging and expressed in volumetric data and in percentage of what planned before the operation. This datum was correlated with predictors variables potentially affecting the final result: six months at least after surgery, a new cone-beam CT was taken;the pre-and postoperative CT datasets were converted into three-dimensional models and digitally aligned; the reconstructed bone volumes (RBV) were calculated according to the planned bone volumes (PBVs), outlining the areas under the mesh. These values were correlated with complications, atrophies' location and the entity of virtually planned bone volume. As secondary outcome the implant results after the prosthetic loading was evaluated in terms of survival, success and complication.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
- Model description
- prospective pilot cohort study
| Arm | Type | Receives |
|---|---|---|
| Subjects undergoing virtually planned GBR for extended and complex alveolar defects. | Other | Device: guided bone regenerationSubjects undergoing virtually planned GBR for extended and complex alveolar defects. The subjects were selected from the population of patients referring to the Oral \& Maxillofacial Surgery Unit of S.Orsola-Malpighi University Hospital for oral function rehabilitation. Eligibility criteria were: the presence of horizontal and vertical alveolar defects in both jaws, inadequate for the placement of at least two fixtures, even ≤6 mm long ones; ≥ 18 years; informed consent signed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The presence of horizontal and vertical alveolar defects in both jaws, inadequate for the placement of at least two fixtures, even ≤6 mm long ones;
- ≥ 18 years;
- informed consent signed.
Key exclusion criteria (11 listed)
- acute or chronic infections in the head and neck;
- smoking >10 cigarettes per day;
- uncontrolled diabetes (glycated hemoglobin level > 7 mg/dL);
- a history of radiation therapy in the head or neck region;
- current antitumor chemotherapy;
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 |
|---|---|---|
| guided bone regenerationAlso: bone reconstructionAfter local anesthesia, the surgery started with a mid-crestal incision with vertical releasing cuts followed by the full-thickness buccal and lingual/palatal flaps raising to expose the bone defect completely. The flaps were coronally extended to assure a complete closure with a passive suture above the titanium. Subsequently, an intra-oral mandibular ramus bone cortical block was harvested in the molar zone. The bone block was milled and mixed with freeze-dried. The particulate graft was put to fill the deficit above the mesh until its perfect stability and unity with the defect's borders. Two or three titanium mini-screws were used to stabilize the device , and the flaps were carefully sutured. Ceftriaxone was administered intravenously at a loading dose of 2 g; together with a non-steroidal analgesic, it was continued at two g/die per os beginning the day after surgery and continuing for six days. | Device | Subjects undergoing virtually planned GBR for extended and complex alveolar defects. |
Primary outcome
Bone regeneration volumes
Time frame: 6 months after surgery
The bone reconstruction was calculated comparing the pre-operative and postoperative volumes. The Reconstructed Bone Volume (RBV) derived by subtracting the Lacking Bone Volume (LBV) values from Planned Bone Volume (PBV) ones. The pre-and postoperative CT datasets were converted into 3D models using Amira imaging software, version 5.3.3. The segmentation regarded almost the entire jaw structure to have at least six precise anatomical points of matching for the superimposition. After that, the pre and postoperative models were digitally aligned with Geomagic Studio 12 software. After the alignment was verified at a minimum range of tolerance of error level of ±0.37 mm in the areas no involved by the surgery, the measurements were performed. In every single slice, the space between the mesh profile and the basal bone was virtually selected and rendered to obtain the PBV; the area representative for the empty space according to the gray-scale of pixels was rendered for the LBV.
3 secondary outcomes
Implant survival.
Time frame: 1 year after implant loading at least.
Complication rate
Time frame: through study completion, an average of 2 years.
Implant success
Time frame: 1 year after implant loading at least.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
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.
Giuseppe lizio, DDS principal investigator
University of Bologna (Italy) UNIBO
Questions about this trial
What is this clinical trial studying?
A study testing guided bone regeneration in people with The Presence of Horizontal and Vertical Alveolar Defects in Both Jaws, Inadequate for the Placement of at Least Two Fixtures, Even ≤6 mm Long Ones, run by University of Bologna.
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 3 inclusion and 11 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: finished, as of the sponsor's last update on 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 regeneration volumes (time frame: 6 months after surgery). 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 28 Jun 2021; AzTrials last refreshed its copy on 30 Oct 2026.