Bone AugmentationNCT04462575
Reconstruction of Atrophic Maxillary Ridges Using Mandibular Blocks With and Without Coverage Using Collagen Membrane
A study testing Onlay bone block covered using collagen membrane and Onlay bone block without collagen membrane in people with Bone Augmentation, run by Cairo University at 1 site in Egypt.
Trial summary
Is the use of collagen membrane on top of particulate bone mixture covered by onlay bone block in Maxilla better than the use of mixture of particulate bone covered by onlay bone block without the use of collagen membrane, in terms of bone quality and bone quantity? Read more about this study
- Who is it for?
- Ages 18 to 46 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Augmentation
- What is being tested?
- Onlay bone block covered using collagen membrane and Onlay bone block without collagen membrane
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2021to 30 Sep 2023
- 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 to 46 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with maxillary residual alveolar bone height not less than 8 mm.
- Alveolar bone width from less than or equal 5 mm.
- Both sexes.
- At least missing single tooth.
- Previous Failed Implants.
- Previous Failed Grafting.
Who cannot join
- Heavy smokers more than 10 cigarettes per day.
- Patients with alcohol abuse
- Patients with narcotic abuse.
- Patients with bone disease that may affect normal healing, example; hyperparathyroidism.
- Patients had radiotherapy and chemotherapy in head and neck.
- Patients had neoplasms in sites to be grafted. 18
Show all 14Show fewer
- Patients with Metabolic diseases uncontrolled diabetic patients, Glycated hemoglobin (Hb A1c) more than 7 mg\dl.
- Pregnant females.
- Patients with Para functional habits, apprehensive and non-cooperative.
- Bone pathology related to the site to be grafted.
- Psychological problems, stress situation (socially or professionally), emotional instability, and unrealistic patients' expectations.
- Intraoral soft and hard tissue pathology.
- Systemic condition that contraindicate implant placement.
- Under the age of 18 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reconstruction of Horizontally Deficient Atrophic Maxillary Ridges Using Mandibular Blocks With and Without Coverage Using Collagen Membrane
Is the use of collagen membrane on top of particulate bone mixture covered by onlay bone block in Maxilla better than the use of mixture of particulate bone covered by onlay bone block without the use of collagen membrane, in terms of bone quality and bone quantity?
Read the detailed description
Soft tissue dehiscence could result due to flap irritation as a result of, closure under tension, intraoperative or postoperative recipient site infection, postoperative edema, which in turns compromises stability of onlay bone blocks thus osseintegration of bone block. Any attempt of bone recontouring and resuturing fails since there is no vascular bed. Ideal requirements of barrier membranes are, they should be biological compatible, they must act as a barrier membrane, unwanted fibroblasts should be hindered from entrance while allowing diffusion of nutrients, tissue integration (biological adhesion), tissues should be able to grow into the membrane but not through it. Space maintainer, it should be sufficiently stiff, so as not to collapse into the underlying particulate bone under the pressure of soft tissue and it should be ease in its manipulation, adaptation and handling, as for example, collagen membrane. Some types of collagen membrane, contain some degrees of stretchability.
- Conditions
- Bone Augmentation
- Being tested
- Onlay bone block covered using collagen membrane, Onlay bone block without collagen membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Onlay bone block covered using collagen membraneProcedure or surgery
The ratio is 40% of xenogenic bone particles (low resorption rate) to 60% of autogenous bone particles (contains viable cells) to be placed in recipient decorticated site and covered by onlay bone block..
Onlay bone block without collagen membraneProcedure or surgery
Onlay bone block without collagen membrane
| Study group | Role | What they receive |
|---|---|---|
| Onlay bone block covered using collagen membrane | Experimental | The onlay bone block (harvested from mandibular intra oral sites) on top of a mixture of particulate autogenous bone and particulate xenogenic bone (assembly going to be fixed by at least 2 micro screws of diameter 1.5 mms and length 13 mms, to avoid micro movements of onlay bone block) covered by collagen membrane, stabilized by resorbable suture and fixed by tacs. Receives: Procedure: Onlay bone block covered using collagen membrane |
| Onlay bone block without collagen membrane | Active comparator | The onlay bone block (harvested from mandibular intra oral sites) on top of a mixture of particulate autogenous bone and particulate xenogenic bone (assembly going to be fixed by at least 2 micro screws of diameter 1.5 mms and length 13 mms, to avoid micro movements of onlay bone block). Receives: Procedure: Onlay bone block without collagen membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity of bone gain.
Measured using linear measurements from Cone Beam Computed Tomography (CBCT) in millimeters (mm).
Measured: after 4 months from ridge augmentation.
Secondary outcomes (1)
Bone Quality.
Measured using Image Analyser Computer System using Histomorphometric method (area percent micrometer square) and optical density
Measured: after 4 months from ridge augmentation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start15 Apr 2021
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Bone AugmentationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohannad Ahmed Ismail, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462575
- Sponsor's protocol ID
- OMFS - (3-3-14)
- Status last verified
- Jul 2024
- First submitted
- 28 Jun 2020
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hammerle CH, Jung RE. Bone augmentation by means of barrier membranes. Periodontol 2000. 2003;33:36-53. doi: 10.1046/j.0906-6713.2003.03304.x. No abstract available.
PubMed 12950840Cash and Alex: 20 years of guided bone regeneration in implant dentistry, 2nd ed. (2009).
Urban IA, Nagursky H, Lozada JL. Horizontal ridge augmentation with a resorbable membrane and particulated autogenous bone with or without anorganic bovine bone-derived mineral: a prospective case series in 22 patients. Int J Oral Maxillofac Implants. 2011 Mar-Apr;26(2):404-14.
PubMed 21483894Urban IA, Nagursky H, Lozada JL, Nagy K. Horizontal ridge augmentation with a collagen membrane and a combination of particulated autogenous bone and anorganic bovine bone-derived mineral: a prospective case series in 25 patients. Int J Periodontics Restorative Dent. 2013 May-Jun;33(3):299-307. doi: 10.11607/prd.1407.
PubMed 23593623Pellegrino G, Lizio G, Corinaldesi G, Marchetti C. Titanium Mesh Technique in Rehabilitation of Totally Edentulous Atrophic Maxillae: A Retrospective Case Series. J Periodontol. 2016 May;87(5):519-28. doi: 10.1902/jop.2016.150432. Epub 2016 Jan 12.
PubMed 26759078Polis-Yanes C, Cadenas-Sebastian C, Gual-Vaques P, Ayuso-Montero R, Mari-Roig A, Lopez-Lopez J. Guided Bone Regeneration of an Atrophic Maxilla Using Heterologous Cortical Lamina. Case Rep Dent. 2019 Jun 11;2019:5216362. doi: 10.1155/2019/5216362. eCollection 2019.
PubMed 31308978Jensen J, Sindet-Pedersen S. Autogenous mandibular bone grafts and osseointegrated implants for reconstruction of the severely atrophied maxilla: a preliminary report. J Oral Maxillofac Surg. 1991 Dec;49(12):1277-87. doi: 10.1016/0278-2391(91)90303-4.
PubMed 1955919Misch CM. Comparison of intraoral donor sites for onlay grafting prior to implant placement. Int J Oral Maxillofac Implants. 1997 Nov-Dec;12(6):767-76.
PubMed 9425757Montazem A, Valauri DV, St-Hilaire H, Buchbinder D. The mandibular symphysis as a donor site in maxillofacial bone grafting: a quantitative anatomic study. J Oral Maxillofac Surg. 2000 Dec;58(12):1368-71. doi: 10.1053/joms.2000.18268.
PubMed 11117684Gungormus M, Yavuz MS. The ascending ramus of the mandible as a donor site in maxillofacial bone grafting. J Oral Maxillofac Surg. 2002 Nov;60(11):1316-8. doi: 10.1053/joms.2002.35731.
PubMed 12420267Clavero J, Lundgren S. Ramus or chin grafts for maxillary sinus inlay and local onlay augmentation: comparison of donor site morbidity and complications. Clin Implant Dent Relat Res. 2003;5(3):154-60. doi: 10.1111/j.1708-8208.2003.tb00197.x.
PubMed 14575631Pourabbas R, Nezafati S. Clinical results of localized alveolar ridge augmentation with bone grafts harvested from symphysis in comparison with ramus. J Dent Res Dent Clin Dent Prospects. 2007 Spring;1(1):7-12. doi: 10.5681/joddd.2007.002. Epub 2007 Jun 10.
PubMed 23277827Acocella A, Bertolai R, Colafranceschi M, Sacco R. Clinical, histological and histomorphometric evaluation of the healing of mandibular ramus bone block grafts for alveolar ridge augmentation before implant placement. J Craniomaxillofac Surg. 2010 Apr;38(3):222-30. doi: 10.1016/j.jcms.2009.07.004. Epub 2009 Aug 3.
PubMed 19648020Spin-Neto R, Landazuri Del Barrio RA, Pereira LA, Marcantonio RA, Marcantonio E, Marcantonio E Jr. Clinical similarities and histological diversity comparing fresh frozen onlay bone blocks allografts and autografts in human maxillary reconstruction. Clin Implant Dent Relat Res. 2013 Aug;15(4):490-7. doi: 10.1111/j.1708-8208.2011.00382.x. Epub 2011 Aug 11.
PubMed 21834864Acocella A, Bertolai R, Ellis E 3rd, Nissan J, Sacco R. Maxillary alveolar ridge reconstruction with monocortical fresh-frozen bone blocks: a clinical, histological and histomorphometric study. J Craniomaxillofac Surg. 2012 Sep;40(6):525-33. doi: 10.1016/j.jcms.2011.09.004. Epub 2011 Nov 9.
PubMed 22075326
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconstruction of Horizontally Deficient Atrophic Maxillary Ridges Using Mandibular Blocks With and Without Coverage Using Collagen Membrane
- ClinicalTrials.gov ID
- NCT04462575
- Acronym / sponsor ID
- OMFS - (3-3-14)
- Conditions
- Bone Augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 8 Jul 2020 (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.
Is the use of collagen membrane on top of particulate bone mixture covered by onlay bone block in Maxilla better than the use of mixture of particulate bone covered by onlay bone block without the use of collagen membrane, in terms of bone quality and bone quantity?
Detailed description
Soft tissue dehiscence could result due to flap irritation as a result of, closure under tension, intraoperative or postoperative recipient site infection, postoperative edema, which in turns compromises stability of onlay bone blocks thus osseintegration of bone block. Any attempt of bone recontouring and resuturing fails since there is no vascular bed. Ideal requirements of barrier membranes are, they should be biological compatible, they must act as a barrier membrane, unwanted fibroblasts should be hindered from entrance while allowing diffusion of nutrients, tissue integration (biological adhesion), tissues should be able to grow into the membrane but not through it. Space maintainer, it should be sufficiently stiff, so as not to collapse into the underlying particulate bone under the pressure of soft tissue and it should be ease in its manipulation, adaptation and handling, as for example, collagen membrane. Some types of collagen membrane, contain some degrees of stretchability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Onlay bone block covered using collagen membrane | Experimental | Procedure: Onlay bone block covered using collagen membraneThe onlay bone block (harvested from mandibular intra oral sites) on top of a mixture of particulate autogenous bone and particulate xenogenic bone (assembly going to be fixed by at least 2 micro screws of diameter 1.5 mms and length 13 mms, to avoid micro movements of onlay bone block) covered by collagen membrane, stabilized by resorbable suture and fixed by tacs. |
| Onlay bone block without collagen membrane | Active comparator | Procedure: Onlay bone block without collagen membraneThe onlay bone block (harvested from mandibular intra oral sites) on top of a mixture of particulate autogenous bone and particulate xenogenic bone (assembly going to be fixed by at least 2 micro screws of diameter 1.5 mms and length 13 mms, to avoid micro movements of onlay bone block). |
Who may qualify
- Ages
- 18 to 46 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients with maxillary residual alveolar bone height not less than 8 mm.
- Alveolar bone width from less than or equal 5 mm.
- Both sexes.
- At least missing single tooth.
- Previous Failed Implants.
Key exclusion criteria (14 listed)
- Heavy smokers more than 10 cigarettes per day.
- Patients with alcohol abuse
- Patients with narcotic abuse.
- Patients with bone disease that may affect normal healing, example; hyperparathyroidism.
- Patients had radiotherapy and chemotherapy in head and neck.
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 |
|---|---|---|
| Onlay bone block covered using collagen membraneThe ratio is 40% of xenogenic bone particles (low resorption rate) to 60% of autogenous bone particles (contains viable cells) to be placed in recipient decorticated site and covered by onlay bone block.. | Procedure or surgery | Onlay bone block covered using collagen membrane |
| Onlay bone block without collagen membraneOnlay bone block without collagen membrane | Procedure or surgery | Onlay bone block without collagen membrane |
Primary outcome
Quantity of bone gain.
Time frame: after 4 months from ridge augmentation.
Measured using linear measurements from Cone Beam Computed Tomography (CBCT) in millimeters (mm).
1 secondary outcome
Bone Quality.
Time frame: after 4 months from ridge augmentation.
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 11 Jul 2024.
- Background: PubMed 12950840Hammerle CH, Jung RE. Bone augmentation by means of barrier membranes. Periodontol 2000. 2003;33:36-53. doi: 10.1046/j.0906-6713.2003.03304.x. No abstract available.
- BackgroundCash and Alex: 20 years of guided bone regeneration in implant dentistry, 2nd ed. (2009).
- Background: PubMed 21483894Urban IA, Nagursky H, Lozada JL. Horizontal ridge augmentation with a resorbable membrane and particulated autogenous bone with or without anorganic bovine bone-derived mineral: a prospective case series in 22 patients. Int J Oral Maxillofac Implants. 2011 Mar-Apr;26(2):404-14.
- Background: PubMed 23593623Urban IA, Nagursky H, Lozada JL, Nagy K. Horizontal ridge augmentation with a collagen membrane and a combination of particulated autogenous bone and anorganic bovine bone-derived mineral: a prospective case series in 25 patients. Int J Periodontics Restorative Dent. 2013 May-Jun;33(3):299-307. doi: 10.11607/prd.1407.
- Background: PubMed 26759078Pellegrino G, Lizio G, Corinaldesi G, Marchetti C. Titanium Mesh Technique in Rehabilitation of Totally Edentulous Atrophic Maxillae: A Retrospective Case Series. J Periodontol. 2016 May;87(5):519-28. doi: 10.1902/jop.2016.150432. Epub 2016 Jan 12.
- Background: PubMed 31308978Polis-Yanes C, Cadenas-Sebastian C, Gual-Vaques P, Ayuso-Montero R, Mari-Roig A, Lopez-Lopez J. Guided Bone Regeneration of an Atrophic Maxilla Using Heterologous Cortical Lamina. Case Rep Dent. 2019 Jun 11;2019:5216362. doi: 10.1155/2019/5216362. eCollection 2019.
- Background: PubMed 1955919Jensen J, Sindet-Pedersen S. Autogenous mandibular bone grafts and osseointegrated implants for reconstruction of the severely atrophied maxilla: a preliminary report. J Oral Maxillofac Surg. 1991 Dec;49(12):1277-87. doi: 10.1016/0278-2391(91)90303-4.
- Background: PubMed 9425757Misch CM. Comparison of intraoral donor sites for onlay grafting prior to implant placement. Int J Oral Maxillofac Implants. 1997 Nov-Dec;12(6):767-76.
- Background: PubMed 11117684Montazem A, Valauri DV, St-Hilaire H, Buchbinder D. The mandibular symphysis as a donor site in maxillofacial bone grafting: a quantitative anatomic study. J Oral Maxillofac Surg. 2000 Dec;58(12):1368-71. doi: 10.1053/joms.2000.18268.
- Background: PubMed 12420267Gungormus M, Yavuz MS. The ascending ramus of the mandible as a donor site in maxillofacial bone grafting. J Oral Maxillofac Surg. 2002 Nov;60(11):1316-8. doi: 10.1053/joms.2002.35731.
- Background: PubMed 14575631Clavero J, Lundgren S. Ramus or chin grafts for maxillary sinus inlay and local onlay augmentation: comparison of donor site morbidity and complications. Clin Implant Dent Relat Res. 2003;5(3):154-60. doi: 10.1111/j.1708-8208.2003.tb00197.x.
- Background: PubMed 23277827Pourabbas R, Nezafati S. Clinical results of localized alveolar ridge augmentation with bone grafts harvested from symphysis in comparison with ramus. J Dent Res Dent Clin Dent Prospects. 2007 Spring;1(1):7-12. doi: 10.5681/joddd.2007.002. Epub 2007 Jun 10.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Onlay bone block covered using collagen membrane and Onlay bone block without collagen membrane in people with Bone Augmentation, run by Cairo University at 1 site in Egypt.
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 6 inclusion and 14 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 11 Jul 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 Egypt. 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?
Quantity of bone gain. (time frame: after 4 months from ridge 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 NCT04462575, which also lists 24 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 11 Jul 2024.