An interventional study of ROG and ROG & ESWT in Bone Regeneration, sponsored by Universidad El Bosque, Bogotá. Completed at 1 site in Colombia. Open to participants aged 35 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-24.
Sponsored by Universidad El Bosque, Bogotá · Not applicable, Interventional, and Treatment
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.
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:
Universidad El Bosque, Bogotá is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
cancellous (1-2 mm) \& cortical (250-1000 mm) bone allograft and pericardium membrane without extracorporeal shockwave therapy
Procedure: ROG · Procedure: ROG & ESWT
cancellous 1-2mm \& cortical 250-1000mm Bonegrafts and membrane with extracorporeal shockwave therapy
Procedure: ROG · Procedure: ROG & ESWT
Bone width augmentation using bone grafting and membrane non cross linking.
Before the bone width augmentation using bone grafting and membrane non cross linking, the patient was received ESWT (Extracorporeal shockwave therapy).
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.
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.
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Aug 2016 to primary completion in Dec 2017, 16 months.
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This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Universidad El Bosque, Bogotá