Bone RegenerationNCT03785717
Horizontal Ridge Augmentation in Mandible Usign ROG + ESWT
A study testing ROG and ROG & ESWT in people with Bone Regeneration, run by Universidad El Bosque, Bogotá at 1 site in Colombia.
Trial summary
Guided bone regeneration (GBR) has been the most frequently used option to treat bone ridge deficiencies, allowing to restore such defects in order to place bone-integrated dental implants. A few reports exist in the literature about the augmentation of mandibular horizontal ridge defects before implant placement. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Regeneration
- What is being tested?
- ROG and ROG & ESWT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteColombia
- Study dates
- Aug 2016to 20 Dec 2018
- 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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who agree to participate in the study and sign informed consent
- Partial mandibular edentulism requiring at least two teeth to be replaced with osseointegrated implants
- Patient with alveolar ridge thickness of ≤4mm, evaluated by CBCT
- Vertical bone availability of 9mm to anatomical structure such as a chin or dental canal that allows a short implant placement of 8mm at the end of the study.
- Extractions performed ≥ 6 months
- Elderly patients between 35 and 65 years old
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- Patients without current disease or with chronic pathologies in medical control that does not affect the healing processes such as: controlled hypertension, controlled hypothyroidism, controlled hypercholesterolemia
- Evaluated by anamnesis and laboratory tests that rule out processes of immunosuppression, glycemia and coagulation disorders hypercholesterolemia
- No smoking
Who cannot join
- Diabetes
- Immunosuppressive drugs
- Anti-coagulated or with dual anti-platelet aggregation
- Therapy with bisphosphonates
- Hormone replacement therapy
- Patient with a history of radiotherapy of the head and neck
Show all 9Show fewer
- Pregnant women or nursing
- Permanent consumption of NSAIDs and corticosteroids
- Prolonged antibiotic therapy in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Horizontal Guide Bone Regeneration With or Without Shock Waves: a Randomized Clinical Trial
Guided bone regeneration (GBR) has been the most frequently used option to treat bone ridge deficiencies, allowing to restore such defects in order to place bone-integrated dental implants. A few reports exist in the literature about the augmentation of mandibular horizontal ridge defects before implant placement. Published studies show a large variability of reported results regarding horizontal bone augmentation. This can be due to the use of different types of membranes and bone graft materials or a combination thereof. Likewise, an important percentage of graft reabsorption is reported. Although this technique is very much used, an important number of cases must be re-treated or require placing bone graft during implant installation surgery. Techniques are required in order to improve vascularization of the grafts during GBR technique with the aim to improve their clinical success. Recent studies show great interest on the application of shock waves in oral diseases associated to infection and bone loss. The shock waves are acoustic waves that have effects on human biological tissues, stimulating the neo-angiogenesis and the development of a hyper cellularity, showing repairing characteristics on tissues, and starting regenerative processes as a result of metabolism improvement and the increase of local circulation. The extra corporeal shock waves can activate the osteoblasts and their precursors and they have been widely used in orthopaedics for repairing bone fractures. Several clinical studies have shown the effectiveness and safety of shock wave therapy in myocardial revascularization, lithotripsy, cellulitis, volar fasciitis, osteonecrosis, bone fractures, and complicated injuries of soft tissues. No clinical studies exist that assess its effect on guided bone regeneration. The evidence related to the positive effects of the use of shock waves on bone regeneration suggests this treatment as a novelty and a promising therapy that combined with the GBR technique for the treatment of horizontal defects could have an important impact on the potentialization of its clinical effectiveness.
Read the detailed description
General Objective:
Assessing the efficacy of horizontal augmentation and percentage of reabsorption of bone graft material in the technique of guided bone regeneration (GBR), combined with the shock wave therapy (SWT) in the horizontal bone reconstruction of mandibular alveolar ridges.
Type of study:
Triple blind randomized clinical trial
Population and sample:
Twenty six patients of university and private clinical practice, who require augmentation of horizontal ridge in the mandible for back placing of an implant, and their compliance with inclusion and exclusion criteria, will be assessed.
Type of analysis:
Central trend and dispersion (medium and standard deviation) measurements will be obtained. Type of data distribution using Shapiro Wilk.
t-student test between no related groups for assessing bone augmentation. t-paired test between related groups for assessing pre and post treatment within the same group.
t test for proportion difference, in order to assess the percentage of reabsorption of bone graft, bone density, bone quality, within a same group.
Fisher, group comparison.
A multiple linear regression model will be developed in order to establish if the difference among groups is influenced by the initial width of the ridge and the thickness of the soft tissue.
In case of not following a normal distribution, no parametrical tests for related and no related groups and logistic regression, will be used.
The frequencies of adverse effects in each group will be obtained, and compared to the Chi2 test or the Fisher exact test.
All the analyses will be made with significance level of 5% (p< 0.05).
Effect measurements: Relative Risk (RR), Attributable Risk Reduction (ARR), and Necessary Number to be Treated (NNT). The augmentation of horizontal volume that allows the installation of a ≥4.1 mm implant will be taken as cutting point reference of clinical success.
Expected Results:
- Establishing the effect of the shock wave therapy, in combination with guided bone regeneration, on the improvement of bone augmentation and the decrease of bone graft reabsorption.
- Establishing the effect of shock wave therapy, in combination with guided bone regeneration, on the improvement of bone quality and density, as well as on decreasing the adverse effects.
- Acquiring new knowledge in the area of bone reconstruction.
- Presentation of results in local and international congresses.
- Formation of human resource; mastery graduation paper on Dentistry Science Master.
- Conditions
- Bone Regeneration
- Being tested
- ROG, ROG & ESWT
- Keywords
- shock wave therapy (SWT or ESWT), Guided bone regeneration (GBR), horizontal ridge augmentation
- Medical subject headings
- Ciliary Dyskinesia, Primary, 13
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROGProcedure or surgery
Bone width augmentation using bone grafting and membrane non cross linking.
ROG & ESWTProcedure or surgery
Before the bone width augmentation using bone grafting and membrane non cross linking, the patient was received ESWT (Extracorporeal shockwave therapy).
| Study group | Role | What they receive |
|---|---|---|
| ROG only | Active comparator | cancellous (1-2 mm) \& cortical (250-1000 mm) bone allograft and pericardium membrane without extracorporeal shockwave therapy Receives: Procedure: ROG; Procedure: ROG & ESWT |
| ROG & ESWT | Active comparator | cancellous 1-2mm \& cortical 250-1000mm Bonegrafts and membrane with extracorporeal shockwave therapy Receives: Procedure: ROG; Procedure: ROG & ESWT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bone width (in mm), as assessed using (CBCT) on a partially edentulous patients after ROG+ESWT.
Using specialized software in dental implantology, measurements are taken in the tomographies taken of each volunteer patient, in order to determine the increase in bone volume in the intervention, and its reabsorption after the healing process.
Measured: Patients will be assessed prior the ROG, two weeks after ROG, and 6 months after ROG in order to determinate actual situation, the situation after the ROG placement and the reabsorption of ROG material.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study startAug 2016
- Primary completion11 Dec 2017
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad El Bosque, Bogotá
- Sponsor type
- University, hospital or other
- Collaborators
- Gloria Lafaurie, Carlos Leal
- Responsible party
- Principal investigator, Yamil Lesmes, Universidad El Bosque, Bogotá
- Investigators
- Yamil Lesmes, Principal investigator, Universidad El Bosque
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785717
- Sponsor's protocol ID
- PCI2015-8351
- Status last verified
- Dec 2018
- First submitted
- 2 Mar 2018
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Horizontal Guide Bone Regeneration With or Without Shock Waves: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03785717
- Acronym / sponsor ID
- PCI2015-8351
- Conditions
- Bone Regeneration
- Keywords
- shock wave therapy (SWT or ESWT), Guided bone regeneration (GBR), horizontal ridge augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Universidad El Bosque, BogotáUniversity, hospital or other
- Collaborators
- Gloria Lafaurie, Carlos Leal
- Study start
- Aug 2016 (actual)
- Primary completion
- 11 Dec 2017 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 24 Dec 2018 (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.
Guided bone regeneration (GBR) has been the most frequently used option to treat bone ridge deficiencies, allowing to restore such defects in order to place bone-integrated dental implants. A few reports exist in the literature about the augmentation of mandibular horizontal ridge defects before implant placement. Published studies show a large variability of reported results regarding horizontal bone augmentation. This can be due to the use of different types of membranes and bone graft materials or a combination thereof. Likewise, an important percentage of graft reabsorption is reported. Although this technique is very much used, an important number of cases must be re-treated or require placing bone graft during implant installation surgery. Techniques are required in order to improve vascularization of the grafts during GBR technique with the aim to improve their clinical success. Recent studies show great interest on the application of shock waves in oral diseases associated to infection and bone loss. The shock waves are acoustic waves that have effects on human biological tissues, stimulating the neo-angiogenesis and the development of a hyper cellularity, showing repairing characteristics on tissues, and starting regenerative processes as a result of metabolism improvement and the increase of local circulation. The extra corporeal shock waves can activate the osteoblasts and their precursors and they have been widely used in orthopaedics for repairing bone fractures. Several clinical studies have shown the effectiveness and safety of shock wave therapy in myocardial revascularization, lithotripsy, cellulitis, volar fasciitis, osteonecrosis, bone fractures, and complicated injuries of soft tissues. No clinical studies exist that assess its effect on guided bone regeneration. The evidence related to the positive effects of the use of shock waves on bone regeneration suggests this treatment as a novelty and a promising therapy that combined with the GBR technique for the treatment of horizontal defects could have an important impact on the potentialization of its clinical effectiveness.
Detailed description
General Objective:
Assessing the efficacy of horizontal augmentation and percentage of reabsorption of bone graft material in the technique of guided bone regeneration (GBR), combined with the shock wave therapy (SWT) in the horizontal bone reconstruction of mandibular alveolar ridges.
Type of study:
Triple blind randomized clinical trial
Population and sample:
Twenty six patients of university and private clinical practice, who require augmentation of horizontal ridge in the mandible for back placing of an implant, and their compliance with inclusion and exclusion criteria, will be assessed.
Type of analysis:
Central trend and dispersion (medium and standard deviation) measurements will be obtained. Type of data distribution using Shapiro Wilk.
t-student test between no related groups for assessing bone augmentation. t-paired test between related groups for assessing pre and post treatment within the same group.
t test for proportion difference, in order to assess the percentage of reabsorption of bone graft, bone density, bone quality, within a same group.
Fisher, group comparison.
A multiple linear regression model will be developed in order to establish if the difference among groups is influenced by the initial width of the ridge and the thickness of the soft tissue.
In case of not following a normal distribution, no parametrical tests for related and no related groups and logistic regression, will be used.
The frequencies of adverse effects in each group will be obtained, and compared to the Chi2 test or the Fisher exact test.
All the analyses will be made with significance level of 5% (p< 0.05).
Effect measurements: Relative Risk (RR), Attributable Risk Reduction (ARR), and Necessary Number to be Treated (NNT). The augmentation of horizontal volume that allows the installation of a ≥4.1 mm implant will be taken as cutting point reference of clinical success.
Expected Results:
- Establishing the effect of the shock wave therapy, in combination with guided bone regeneration, on the improvement of bone augmentation and the decrease of bone graft reabsorption.
- Establishing the effect of shock wave therapy, in combination with guided bone regeneration, on the improvement of bone quality and density, as well as on decreasing the adverse effects.
- Acquiring new knowledge in the area of bone reconstruction.
- Presentation of results in local and international congresses.
- Formation of human resource; mastery graduation paper on Dentistry Science Master.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ROG only | Active comparator | Procedure: ROG, Procedure: ROG & ESWTcancellous (1-2 mm) \& cortical (250-1000 mm) bone allograft and pericardium membrane without extracorporeal shockwave therapy |
| ROG & ESWT | Active comparator | Procedure: ROG, Procedure: ROG & ESWTcancellous 1-2mm \& cortical 250-1000mm Bonegrafts and membrane with extracorporeal shockwave therapy |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients who agree to participate in the study and sign informed consent
- Partial mandibular edentulism requiring at least two teeth to be replaced with osseointegrated implants
- Patient with alveolar ridge thickness of ≤4mm, evaluated by CBCT
- Vertical bone availability of 9mm to anatomical structure such as a chin or dental canal that allows a short implant placement of 8mm at the end of the study.
- Extractions performed ≥ 6 months
Key exclusion criteria (9 listed)
- Diabetes
- Immunosuppressive drugs
- Anti-coagulated or with dual anti-platelet aggregation
- Therapy with bisphosphonates
- Hormone replacement therapy
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 |
|---|---|---|
| ROGBone width augmentation using bone grafting and membrane non cross linking. | Procedure or surgery | ROG & ESWT, ROG only |
| ROG & ESWTBefore the bone width augmentation using bone grafting and membrane non cross linking, the patient was received ESWT (Extracorporeal shockwave therapy). | Procedure or surgery | ROG & ESWT, ROG only |
Primary outcome
Change in Bone width (in mm), as assessed using (CBCT) on a partially edentulous patients after ROG+ESWT.
Time frame: Patients will be assessed prior the ROG, two weeks after ROG, and 6 months after ROG in order to determinate actual situation, the situation after the ROG placement and the reabsorption of ROG material.
Using specialized software in dental implantology, measurements are taken in the tomographies taken of each volunteer patient, in order to determine the increase in bone volume in the intervention, and its reabsorption after the healing process.
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 24 Dec 2018.
- Individual participant dataSharing planned: Undecided
Related trials for 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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Lactoferrin Nanohydrogel for Soft And Hard Tissue Healing and Implant Stability in Immediate Implant Placement
Immediate Dental Implant Placement Dental Implant Stability Soft Tissue Healing Bone Regeneration Lactoferrin Nanohydrogel, Dental Implant Stability - Bone Regeneration
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Guided Bone Regeneration Using Polydioxanone (PDO) Membrane in Sockets After Tooth Extraction
Surgery, Oral
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
Not yet recruiting
Comparison of Three Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
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.
Yamil Lesmes principal investigator
Universidad El Bosque
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ROG and ROG & ESWT in people with Bone Regeneration, run by Universidad El Bosque, Bogotá at 1 site in Colombia.
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 9 inclusion and 9 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 24 Dec 2018. 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 Colombia. 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?
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?
Change in Bone width (in mm), as assessed using (CBCT) on a partially edentulous patients after ROG+ESWT. (time frame: Patients will be assessed prior the ROG, two weeks after ROG, and 6 months after ROG in order to determinate actual situation, the situation after the ROG placement and the reabsorption of ROG material.). 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 24 Dec 2018.