Alveolar Ridge AugmentationNCT03712631
Ridge Augmentation in Posterior Mandible Using Tunneling Technique With Amix of Autogenous Bone and Xenograft With and Without Collagen Membrane
A study testing tunneling technique bone augmentation in people with Alveolar Ridge Augmentation, run by Cairo University.
Trial summary
aim Evaluation of the amount of bone gain following Ridge augmentation using tunneling technique in atrophic posterior mandibular ridges using anorganic bovine bone derived mineral mixed with particulated autogenous bone chips with collagen membrane Read more about this study
- Who is it for?
- Ages 22 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Ridge Augmentation
- What is being tested?
- tunneling technique bone augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2018to Dec 2019
- 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 22 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- medically free,age 22:50 years, atrophic posterior mandibleClinical diagnosis of Alzheimer's Disease Must be able to swallow tablets
Who cannot join
- smoking Insulin dependent diabetes Clinical diagnosis of Alzheimer's Disease Must be able to swallow tablets
About this study
Official title: Ridge Augmentation in Atrophic Posterior Mandible Using Tunneling Technique With Anorganic Bovine Bone-Derived Mineral Mixed With Particulated Autogenous Bone Chips With and Without Collagen Membrane
aim Evaluation of the amount of bone gain following Ridge augmentation using tunneling technique in atrophic posterior mandibular ridges using anorganic bovine bone derived mineral mixed with particulated autogenous bone chips with collagen membrane
Read the detailed description
Bone grafting before implant placement has become a routine procedure over the last 20 years. A 5-year survival rate of up to98.3% for implants placed in grafted bone has been reported.
Autologous bone grafts are considered the gold standard.However, the success rate of the grafting procedure may beinfluenced by various risk factors.
A particular challenge isposed by an extensive graft of the alveolar ridge, with relativelyhigh complication rates of up to 20% being reported, mostcommonly dehiscence. More serious complications such asdehiscence or mobilization of the graft were observed in one third of smokers compared to a complication rate of only 7.7%for non-smokers. Complications such as flap necroses, dehiscenceand resorption are frequently soft-tissue complications.
A tension-free wound closure is a key factor in the successof bone grafts. Periosteal incisions are a common techniquefor flap extension. However, too many relief incisions in the periosteum may also result in an excessively thin or stretched wound flap.
This type of soft-tissue management may result in perforation or flap necrosis above the bone graft.
In 1987 Härle reported on a tunneling access in connectionwith a technique for preprosthetic jaw ridge grafting in the mandibular side-tooth region with bone replacement materials.
In the clinical experience of the authors the use of a tunneling technique for preparation without a crestal incision can present an alternative with autologous bone grafts to conventional surgical procedures with a trapezoid flap design.
- Conditions
- Alveolar Ridge Augmentation
- Being tested
- tunneling technique bone augmentation
- Keywords
- tunneling technique, collagen membrane, tunnel, augmentation, horizontal ridge augmentation, bone graft, ridge augmentation, posterior mandible
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tunneling technique bone augmentationProcedure or surgery
horizontal ridge augmentation using mixture of xenograft,autogenous bone
| Study group | Role | What they receive |
|---|---|---|
| bone without a collagen membrane | Active comparator | not covering bone with collagen membrane Receives: Procedure: tunneling technique bone augmentation |
| bone with collagen membrane | Experimental | covering bone with collagen membrane Receives: Procedure: tunneling technique bone augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height and width of bone gained
Measured: 4 months
Secondary outcomes (1)
Bone area percentage
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study startOct 2018 (estimated)
- Primary completionMay 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Alveolar Ridge 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, haytham mohamed ahmed ibrahim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712631
- Sponsor's protocol ID
- augmentation tunneling tech
- Status last verified
- Oct 2018
- First submitted
- 17 Oct 2018
- Last updated
- 22 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Hasson O. Augmentation of deficient lateral alveolar ridge using the subperiosteal tunneling dissection approach. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Mar;103(3):e14-9. doi: 10.1016/j.tripleo.2006.10.019. Epub 2007 Jan 22.
PubMed 17241798Maestre-Ferrin L, Boronat-Lopez A, Penarrocha-Diago M, Penarrocha-Diago M. Augmentation procedures for deficient edentulous ridges, using onlay autologous grafts: an update. Med Oral Patol Oral Cir Bucal. 2009 Aug 1;14(8):e402-7.
PubMed 19415058de Macedo LG, de Macedo NL, do Socorro Ferreira Monteiro A. Fresh-frozen human bone graft for repair of defect after adenomatoid odontogenic tumour removal. Cell Tissue Bank. 2009 Aug;10(3):221-6. doi: 10.1007/s10561-008-9120-1. Epub 2009 Jan 9.
PubMed 19132551Khan SN, Cammisa FP Jr, Sandhu HS, Diwan AD, Girardi FP, Lane JM. The biology of bone grafting. J Am Acad Orthop Surg. 2005 Jan-Feb;13(1):77-86.
PubMed 157129859. Fonseca RJ, Powers MP, Dexter H. Oral and max¬illofacial surgery: Reconstructive and implant surgery. Philadelphia: WB Saunders Co. 2007; 7.
Kent JN. Reconstruction of the alveolar ridge with hydroxyapatite. Dent Clin North Am. 1986 Apr;30(2):231-57.
PubMed 3009242Smiler D, Soltan M, Lee JW. A histomorphogenic analysis of bone grafts augmented with adult stem cells. Implant Dent. 2007 Mar;16(1):42-53. doi: 10.1097/ID.0b013e3180335934.
PubMed 17356371Rothstein SS, Paris DA, Zacek MP. Use of hydroxylapatite for the augmentation of deficient alveolar ridges. J Oral Maxillofac Surg. 1984 Apr;42(4):224-30. doi: 10.1016/0278-2391(84)90453-1.
PubMed 6323657Mehlisch DR, Taylor TD, Leibold DG, Hiatt R, Waite DE, Waite PD, Laskin DM, Smith ST. Collagen/hydroxylapatite implant for augmenting deficient alveolar ridges: twelve-month clinical data. J Oral Maxillofac Surg. 1988 Oct;46(10):839-43. doi: 10.1016/0278-2391(88)90046-8.
PubMed 2845038Williams CW, Meyers JF, Robinson RR. Hydroxyapatite augmentation of the anterior portion of the maxilla with a modified transpositional flap technique. Oral Surg Oral Med Oral Pathol. 1991 Oct;72(4):395-9. doi: 10.1016/0030-4220(91)90546-o.
PubMed 1656356Marshall SG. The combined use of endosseous dental implants and collagen/hydroxylapatite augmentation procedures for reconstruction/augmentation of the edentulous and atrophic mandible: a preliminary report. Oral Surg Oral Med Oral Pathol. 1989 Oct;68(4 Pt 2):517-25; discussion 525-6. doi: 10.1016/0030-4220(89)90231-4.
PubMed 2559388Kfir E, Kfir V, Eliav E, Kaluski E. Minimally invasive guided bone regeneration. J Oral Implantol. 2007;33(4):205-10. doi: 10.1563/1548-1336(2007)33[205:MIGBR]2.0.CO;2.
PubMed 17912961Li J, Xuan F, Choi BH, Jeong SM. Minimally invasive ridge augmentation using xenogenous bone blocks in an atrophied posterior mandible: a clinical and histological study. Implant Dent. 2013 Apr;22(2):112-6. doi: 10.1097/ID.0b013e3182805bec.
PubMed 23344366Vanassche BJ, Stoelinga PJ, de Koomen HA, Blijdorp PA, Schoenaers JH. Reconstruction of the severely resorbed mandible with interposed bone grafts and hydroxylapatite. A 2-3 year follow-up. Int J Oral Maxillofac Surg. 1988 Jun;17(3):157-60. doi: 10.1016/s0901-5027(88)80021-3.
PubMed 2840471Block MS. Horizontal ridge augmentation using particulate bone. Atlas Oral Maxillofac Surg Clin North Am. 2006 Mar;14(1):27-38. doi: 10.1016/j.cxom.2005.11.004. No abstract available.
PubMed 16522508
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ridge Augmentation in Atrophic Posterior Mandible Using Tunneling Technique With Anorganic Bovine Bone-Derived Mineral Mixed With Particulated Autogenous Bone Chips With and Without Collagen Membrane
- ClinicalTrials.gov ID
- NCT03712631
- Acronym / sponsor ID
- augmentation tunneling tech
- Conditions
- Alveolar Ridge Augmentation
- Keywords
- tunneling technique, collagen membrane, tunnel, augmentation, horizontal ridge augmentation, bone graft, ridge augmentation, posterior mandible
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- May 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 19 Oct 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.
aim Evaluation of the amount of bone gain following Ridge augmentation using tunneling technique in atrophic posterior mandibular ridges using anorganic bovine bone derived mineral mixed with particulated autogenous bone chips with collagen membrane
Detailed description
Bone grafting before implant placement has become a routine procedure over the last 20 years. A 5-year survival rate of up to98.3% for implants placed in grafted bone has been reported.
Autologous bone grafts are considered the gold standard.However, the success rate of the grafting procedure may beinfluenced by various risk factors.
A particular challenge isposed by an extensive graft of the alveolar ridge, with relativelyhigh complication rates of up to 20% being reported, mostcommonly dehiscence. More serious complications such asdehiscence or mobilization of the graft were observed in one third of smokers compared to a complication rate of only 7.7%for non-smokers. Complications such as flap necroses, dehiscenceand resorption are frequently soft-tissue complications.
A tension-free wound closure is a key factor in the successof bone grafts. Periosteal incisions are a common techniquefor flap extension. However, too many relief incisions in the periosteum may also result in an excessively thin or stretched wound flap.
This type of soft-tissue management may result in perforation or flap necrosis above the bone graft.
In 1987 Härle reported on a tunneling access in connectionwith a technique for preprosthetic jaw ridge grafting in the mandibular side-tooth region with bone replacement materials.
In the clinical experience of the authors the use of a tunneling technique for preparation without a crestal incision can present an alternative with autologous bone grafts to conventional surgical procedures with a trapezoid flap design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bone without a collagen membrane | Active comparator | Procedure: tunneling technique bone augmentationnot covering bone with collagen membrane |
| bone with collagen membrane | Experimental | Procedure: tunneling technique bone augmentationcovering bone with collagen membrane |
Who may qualify
- Ages
- 22 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- medically free,age 22:50 years, atrophic posterior mandibleClinical diagnosis of Alzheimer's Disease Must be able to swallow tablets
Key exclusion criteria (1 listed)
- smoking Insulin dependent diabetes Clinical diagnosis of Alzheimer's Disease Must be able to swallow tablets
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 |
|---|---|---|
| tunneling technique bone augmentationhorizontal ridge augmentation using mixture of xenograft,autogenous bone | Procedure or surgery | bone with collagen membrane, bone without a collagen membrane |
Primary outcome
Height and width of bone gained
Time frame: 4 months
1 secondary outcome
Bone area percentage
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2018.
- Background: PubMed 17241798Hasson O. Augmentation of deficient lateral alveolar ridge using the subperiosteal tunneling dissection approach. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Mar;103(3):e14-9. doi: 10.1016/j.tripleo.2006.10.019. Epub 2007 Jan 22.
- Background: PubMed 19415058Maestre-Ferrin L, Boronat-Lopez A, Penarrocha-Diago M, Penarrocha-Diago M. Augmentation procedures for deficient edentulous ridges, using onlay autologous grafts: an update. Med Oral Patol Oral Cir Bucal. 2009 Aug 1;14(8):e402-7.
- Background: PubMed 19132551de Macedo LG, de Macedo NL, do Socorro Ferreira Monteiro A. Fresh-frozen human bone graft for repair of defect after adenomatoid odontogenic tumour removal. Cell Tissue Bank. 2009 Aug;10(3):221-6. doi: 10.1007/s10561-008-9120-1. Epub 2009 Jan 9.
- Background: PubMed 15712985Khan SN, Cammisa FP Jr, Sandhu HS, Diwan AD, Girardi FP, Lane JM. The biology of bone grafting. J Am Acad Orthop Surg. 2005 Jan-Feb;13(1):77-86.
- Background9. Fonseca RJ, Powers MP, Dexter H. Oral and max¬illofacial surgery: Reconstructive and implant surgery. Philadelphia: WB Saunders Co. 2007; 7.
- Background: PubMed 3009242Kent JN. Reconstruction of the alveolar ridge with hydroxyapatite. Dent Clin North Am. 1986 Apr;30(2):231-57.
- Background: PubMed 17356371Smiler D, Soltan M, Lee JW. A histomorphogenic analysis of bone grafts augmented with adult stem cells. Implant Dent. 2007 Mar;16(1):42-53. doi: 10.1097/ID.0b013e3180335934.
- Background: PubMed 6323657Rothstein SS, Paris DA, Zacek MP. Use of hydroxylapatite for the augmentation of deficient alveolar ridges. J Oral Maxillofac Surg. 1984 Apr;42(4):224-30. doi: 10.1016/0278-2391(84)90453-1.
- Background: PubMed 2845038Mehlisch DR, Taylor TD, Leibold DG, Hiatt R, Waite DE, Waite PD, Laskin DM, Smith ST. Collagen/hydroxylapatite implant for augmenting deficient alveolar ridges: twelve-month clinical data. J Oral Maxillofac Surg. 1988 Oct;46(10):839-43. doi: 10.1016/0278-2391(88)90046-8.
- Background: PubMed 1656356Williams CW, Meyers JF, Robinson RR. Hydroxyapatite augmentation of the anterior portion of the maxilla with a modified transpositional flap technique. Oral Surg Oral Med Oral Pathol. 1991 Oct;72(4):395-9. doi: 10.1016/0030-4220(91)90546-o.
- Background: PubMed 2559388Marshall SG. The combined use of endosseous dental implants and collagen/hydroxylapatite augmentation procedures for reconstruction/augmentation of the edentulous and atrophic mandible: a preliminary report. Oral Surg Oral Med Oral Pathol. 1989 Oct;68(4 Pt 2):517-25; discussion 525-6. doi: 10.1016/0030-4220(89)90231-4.
- Background: PubMed 17912961Kfir E, Kfir V, Eliav E, Kaluski E. Minimally invasive guided bone regeneration. J Oral Implantol. 2007;33(4):205-10. doi: 10.1563/1548-1336(2007)33[205:MIGBR]2.0.CO;2.
- Individual participant dataSharing planned: Yes
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Alveolar Ridge Augmentation, Bone Substitutes
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.
Questions about this trial
What is this clinical trial studying?
A study testing tunneling technique bone augmentation in people with Alveolar Ridge Augmentation, run by Cairo University.
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 1 inclusion and 1 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 22 Oct 2018. 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?
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?
Height and width of bone gained (time frame: 4 months). 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 NCT03712631, which also lists 39 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 22 Oct 2018.