Dental ImplantsNCT00878332
Histologic Evaluation of Bone Formation After Alveolar Augmentation by "Sandwich Osteotomy" Procedure for Dental Implants Insertion
An observational study of Dental Implants, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The purpose of this study is to evaluate histologic bone remodeling after interpositional bone graft ("sandwich osteotomy" technique) using xenograft to fill the gap of the bone after moving and fixation it in the proper place. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implants
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2009to Apr 2011
- Phase
- Observational
- 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
Study population: patients refered to the oral and maxillofacial clinic for bone augmentation (because of insufficient bone height) and fixed rehabilitation using dental implants
Who may be able to join
- age > 18 years
- partially edentulous patients
- insufficient bone height (recipient site)
- interested in fixed dental rehabilitation using dental implants
Who cannot join
- smoking
- unbalanced diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Sandwich Osteotomy" Histologic Evaluation
The purpose of this study is to evaluate histologic bone remodeling after interpositional bone graft ("sandwich osteotomy" technique) using xenograft to fill the gap of the bone after moving and fixation it in the proper place.
Read the detailed description
Dental implant use for partially edentolous jaw is a predictable procedure with high success rate. However, implantation procedure requires sufficient bone support both vertically and horizontally, and sometimes there is bone defect that requires bone augmentation prior to dental implant insertion.
There are some bone augmentation techniques known and used for this purposes, including: guided bone regeneration (GBR), distraction osteogenesis, split osteotomy, onlay bone graft, and interpositional bone graft.
One of the techniques is the interpositional bone graft using "sandwich osteotomy" technique, in which a cut is made in the bone (one horizontal and two vertical) separating a mobile bone portion which is fixed (using bone plate) in its new "ideal" position. The gap between the moved bone and the remaining bone is filled with xenograft ("bio-oss"). There is no documentation in the literature about histological evaluation of the bone after this well known clinical procedure. Four months after the bone augmentation procedure - the fixating plate is moved out and dental implants inserted. The first bur of the implantation (the smallest in the diameter) will be a trephine from which a histologic slide will be taken for check. The continuous dental implants insertion is the normal protocol for dental implantation (widening the recipient hole with bur, and insertion of the implant), followed by rehabilitation by prosthodontics.
- Conditions
- Dental Implants
- Keywords
- edentulous, fixed dental rehabilitation, insufficient bone height, Partially edentulous patients, Patients interested in fixed non removable dental rehabilitation by dental implants., The recipient bone with insufficient bone height for dental implant insertion., Adult patients
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| partially edentulous patients | Adult (post growth period) patients who are interested in fixed dental rehabilitation (non- removable denture) by dental implants. Partially edentulous patients with insufficient bone height for dental implant insertion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histologic slide evaluation of the bone on the dental implantation time
Measured: implantation day (four months post bone augmentation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2009 (estimated)
- Study startFeb 2009
- Primary completionApr 2010 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantsStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Nardy Caspi, MD / DMD, Principal investigator, Senior Lecturer oral and maxillofacial surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00878332
- Sponsor's protocol ID
- sandwich osteotomy-HMO-CTIL
- Status last verified
- Mar 2009
- First submitted
- 7 Apr 2009
- Last updated
- 8 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jensen OT. Alveolar segmental "sandwich" osteotomies for posterior edentulous mandibular sites for dental implants. J Oral Maxillofac Surg. 2006 Mar;64(3):471-5. doi: 10.1016/j.joms.2005.11.030.
PubMed 16487811Jensen OT, Kuhlke L, Bedard JF, White D. Alveolar segmental sandwich osteotomy for anterior maxillary vertical augmentation prior to implant placement. J Oral Maxillofac Surg. 2006 Feb;64(2):290-6. doi: 10.1016/j.joms.2005.10.021.
PubMed 16413903Stellingsma C, Raghoebar GM, Meijer HJ, Batenburg RH. Reconstruction of the extremely resorbed mandible with interposed bone grafts and placement of endosseous implants. A preliminary report on outcome of treatment and patients' satisfaction. Br J Oral Maxillofac Surg. 1998 Aug;36(4):290-5. doi: 10.1016/s0266-4356(98)90713-6.
PubMed 9762457Marchetti C, Trasarti S, Corinaldesi G, Felice P. Interpositional bone grafts in the posterior mandibular region: a report on six patients. Int J Periodontics Restorative Dent. 2007 Dec;27(6):547-55.
PubMed 18092449Yeung R. Surgical management of the partially edentulous atrophic mandibular ridge using a modified sandwich osteotomy: a case report. Int J Oral Maxillofac Implants. 2005 Sep-Oct;20(5):799-803.
PubMed 16274157Robiony M, Costa F, Politi M. Alveolar sandwich osteotomy of the anterior maxilla. J Oral Maxillofac Surg. 2006 Sep;64(9):1453-4; author reply 1454-5. doi: 10.1016/j.joms.2006.02.006. No abstract available.
PubMed 16916686Politi M, Robiony M. Localized alveolar sandwich osteotomy for vertical augmentation of the anterior maxilla. J Oral Maxillofac Surg. 1999 Nov;57(11):1380-2. doi: 10.1016/s0278-2391(99)90883-2. No abstract available.
PubMed 10555808
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Sandwich Osteotomy" Histologic Evaluation
- ClinicalTrials.gov ID
- NCT00878332
- Acronym / sponsor ID
- sandwich osteotomy-HMO-CTIL
- Conditions
- Dental Implants
- Keywords
- edentulous, fixed dental rehabilitation, insufficient bone height, Partially edentulous patients, Patients interested in fixed non removable dental rehabilitation by dental implants., The recipient bone with insufficient bone height for dental implant insertion., Adult patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 8 Apr 2009 (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.
The purpose of this study is to evaluate histologic bone remodeling after interpositional bone graft ("sandwich osteotomy" technique) using xenograft to fill the gap of the bone after moving and fixation it in the proper place.
Detailed description
Dental implant use for partially edentolous jaw is a predictable procedure with high success rate. However, implantation procedure requires sufficient bone support both vertically and horizontally, and sometimes there is bone defect that requires bone augmentation prior to dental implant insertion.
There are some bone augmentation techniques known and used for this purposes, including: guided bone regeneration (GBR), distraction osteogenesis, split osteotomy, onlay bone graft, and interpositional bone graft.
One of the techniques is the interpositional bone graft using "sandwich osteotomy" technique, in which a cut is made in the bone (one horizontal and two vertical) separating a mobile bone portion which is fixed (using bone plate) in its new "ideal" position. The gap between the moved bone and the remaining bone is filled with xenograft ("bio-oss"). There is no documentation in the literature about histological evaluation of the bone after this well known clinical procedure. Four months after the bone augmentation procedure - the fixating plate is moved out and dental implants inserted. The first bur of the implantation (the smallest in the diameter) will be a trephine from which a histologic slide will be taken for check. The continuous dental implants insertion is the normal protocol for dental implantation (widening the recipient hole with bur, and insertion of the implant), followed by rehabilitation by prosthodontics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| partially edentulous patients | – | –Adult (post growth period) patients who are interested in fixed dental rehabilitation (non- removable denture) by dental implants. Partially edentulous patients with insufficient bone height for dental implant insertion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients refered to the oral and maxillofacial clinic for bone augmentation (because of insufficient bone height) and fixed rehabilitation using dental implants
Key inclusion criteria (4 listed)
- age > 18 years
- partially edentulous patients
- insufficient bone height (recipient site)
- interested in fixed dental rehabilitation using dental implants
Key exclusion criteria (2 listed)
- smoking
- unbalanced diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Histologic slide evaluation of the bone on the dental implantation time
Time frame: implantation day (four months post bone augmentation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2009.
- Background: PubMed 16487811Jensen OT. Alveolar segmental "sandwich" osteotomies for posterior edentulous mandibular sites for dental implants. J Oral Maxillofac Surg. 2006 Mar;64(3):471-5. doi: 10.1016/j.joms.2005.11.030.
- Background: PubMed 16413903Jensen OT, Kuhlke L, Bedard JF, White D. Alveolar segmental sandwich osteotomy for anterior maxillary vertical augmentation prior to implant placement. J Oral Maxillofac Surg. 2006 Feb;64(2):290-6. doi: 10.1016/j.joms.2005.10.021.
- Background: PubMed 9762457Stellingsma C, Raghoebar GM, Meijer HJ, Batenburg RH. Reconstruction of the extremely resorbed mandible with interposed bone grafts and placement of endosseous implants. A preliminary report on outcome of treatment and patients' satisfaction. Br J Oral Maxillofac Surg. 1998 Aug;36(4):290-5. doi: 10.1016/s0266-4356(98)90713-6.
- Background: PubMed 18092449Marchetti C, Trasarti S, Corinaldesi G, Felice P. Interpositional bone grafts in the posterior mandibular region: a report on six patients. Int J Periodontics Restorative Dent. 2007 Dec;27(6):547-55.
- Background: PubMed 16274157Yeung R. Surgical management of the partially edentulous atrophic mandibular ridge using a modified sandwich osteotomy: a case report. Int J Oral Maxillofac Implants. 2005 Sep-Oct;20(5):799-803.
- Background: PubMed 16916686Robiony M, Costa F, Politi M. Alveolar sandwich osteotomy of the anterior maxilla. J Oral Maxillofac Surg. 2006 Sep;64(9):1453-4; author reply 1454-5. doi: 10.1016/j.joms.2006.02.006. No abstract available.
- Background: PubMed 10555808Politi M, Robiony M. Localized alveolar sandwich osteotomy for vertical augmentation of the anterior maxilla. J Oral Maxillofac Surg. 1999 Nov;57(11):1380-2. doi: 10.1016/s0278-2391(99)90883-2. No abstract available.
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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.
Nardy Caspi, MD / DMD principal investigator
Senior Lecturer oral and maxillofacial surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Implants, run by Hadassah Medical Organization at 1 site in Israel.
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 2 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 8 Apr 2009. 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 Israel. 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?
Histologic slide evaluation of the bone on the dental implantation time (time frame: implantation day (four months post bone augmentation)). 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 NCT00878332, which also lists 7 linked publications.
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 8 Apr 2009.