Ridge AugmentationNCT06746935
Reconstruction of Deficient Atrophic Ridges Using Guide Bone Regeneration Technique
A study testing Collagen membrane. and Polytetrafluoroethylene membrane. in people with Ridge Augmentation and Bone Augmentation, run by Cairo University at 1 site in Egypt.
Trial summary
patients will be informed of the nature of the research work and informed consent will be obtained then randomized in 2 groups. Mixture 1:1 autogenous and xenogenic bone covered with Polytetrafluoroethylene membrane control group and study group p covered with native collagen membrane. Read more about this study
- Who is it for?
- Ages 20 to 48 years
- Conditions the study is for
- Ridge Augmentation, Bone Augmentation
- What is being tested?
- Collagen membrane. and Polytetrafluoroethylene membrane.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 29 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 48 years
- All sexes
- No healthy volunteers
- 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 20 cigarettes per day.
- 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.
- Patients with Metabolic diseases uncontrolled diabetic patients, Glycated hemoglobin (Hb A1c) more than 7 mg\dl.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry Cairo University
Cairo, 11553
Ahmed M. Youssef, Lecturer, +201067941236 ext. +20, ahmed.youssef@dentistry.cu.edu.eg
About this study
Official title: Reconstruction of Deficient Atrophic Ridges Using Guided Bone Regeneration Technique With Native Collagen Membrane and Polytetrafluoroethylene Membrane (Randomized Clinical Trial)
patients will be informed of the nature of the research work and informed consent will be obtained then randomized in 2 groups. Mixture 1:1 autogenous and xenogenic bone covered with Polytetrafluoroethylene membrane control group and study group p covered with native collagen membrane.
- Patients of both groups will be subjected to CBCT (diagnostic for upper arch), diagnostic wax-up and stent fabrication.
- Intra operative procedures (for both groups) followed by CBCT will be taken for every patient after 4 months.
Read more
Both the study and control group will receive:
- In Recipient site, using 15C blade on Bard Parker handle incision of full thickness mucoperiosteal flap inorder to obtain, three-line pyramidal flap, reflection using mucoperiosteal elevator molt 9.
- The defective site is reevaluated after its primary evaluation on CBCT using UNC (University of North Carolina) periodontal probe and a template is cut using sterile suture pack, prior to donor site preparation.
- Flap advancement using periosteal releasing incision inorder to allow later tension free flap closure.
- In Donor site, mucoperiosteal flap is done, auto chip maker (ACM) is used for autogenous bone harvesting.
- Autogenous particulate bone graft is obtained using auto chip maker bur (ACM), in implant contra 20:1 using surgical motor recommended drilling speed 100 rpm and maximum torque 50 Ncm. as well as, using bone scrapper in push direction.
- Xenogenic bone graft particles (De-proteinized bovine bone mineral small granules (0.25-1 mm). is added to the autogenous bone particles to obtain homogenous mixture ratio 1:1.
- The gold standard is a mixture of autogenous bone containing viable cells and xenogenic bone which has slower rate of resorption is to be placed in recipient decorticated site and covered by PTFE membrane.
- The assemble is to be fixed by titanium bone tacks of diameter 2.5 mm and length 3.5 mm, to avoid micro movements of particulate bone assembly.
- In the Study group: The assemble is going to be covered by resorbable collagen membrane and fixed by tacks.
- Recheck adequate flap advancement by visualizing passive flap approximation, to allow tension free closure.
- Double line closure using horizontal mattress placed 5mm away from flap margins followed by interrupted sutures on top to allow contact area which is preferred to point contact and wound edge eversion.
Read the detailed description
.General operative procedures The selected patients will be informed of the nature of the research work and informed consent will be obtained then randomized in equal proportions between control group particulate bone mixture 1:1 autogenous and xenogenic bone covered with Polytetrafluoroethylene membrane and study group particulate bone mixture 1:1 autogenous and xenogenic bone covered with native collagen membrane.
- Patients of both groups will be subjected to CBCT (diagnostic for upper arch), diagnostic wax-up and stent fabrication.
- Intra operative procedures (for both groups) followed by CBCT will be taken for every patient after 4 months.
- Infiltration local anesthesia will be given to the patient (Articaine 4% 1:100 000 epinephrine).
Both the study and control group will receive:
- In Recipient site, preparation 1st to obtain, three-line pyramidal flap.
- Flap advancement using periosteal releasing incision.
- In Donor site, auto chip maker (ACM) is used for autogenous bone harvesting and xenogenic bone graft particles mixture ratio 1:1.
- The assemble is to be fixed by titanium bone tacks. In the Study group: The assemble is going to be covered by collagen membrane.
- Double line closure using horizontal mattress placed 5mm away from flap margins followed by interrupted sutures on top to allow contact area which is preferred to point contact and wound edge eversion.
- Conditions
- Ridge Augmentation, Bone Augmentation
- Being tested
- Collagen membrane., Polytetrafluoroethylene membrane.
- Keywords
- ridge augmentation, Polytetrafluoroethylene, native collagen membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen membrane.Procedure or surgery
Particulate bone mixture 1:1 autogenous and xenogenic bone covered with native collagen membrane.
Polytetrafluoroethylene membrane.Procedure or surgery
Particulate bone mixture 1:1 autogenous and xenogenic bone covered with polytetrafluoroethylene membrane.
| Study group | Role | What they receive |
|---|---|---|
| Control Group B polytetrafluoroethylene membrane. | Active comparator | Particulate bone mixture 1:1 autogenous and xenogenic bone covered with polytetrafluoroethylene membrane. Receives: Procedure: Polytetrafluoroethylene membrane. |
| Study Group A native collagen membrane. | Experimental | Particulate bone mixture 1:1 autogenous and xenogenic bone covered with native collagen membrane. Receives: Procedure: 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)
Soft tissue dehiscence.
Exposure of barrier membrane and impaied wound healing.
Measured: Starting from Week 1. Binary Yes or No.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start1 Jan 2025
- Primary completion30 Jun 2025 (estimated)
- Study completion29 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohannad Ahmed Ismail, Cairo University
- Investigators
- Ahmed M. Youssef, PHD., Study director, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746935
- Sponsor's protocol ID
- 0000-0001-6142-0568
- Status last verified
- Feb 2025
- First submitted
- 15 Dec 2024
- Last updated
- 19 Feb 2025
- 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 12950840Pellegrino 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 22075326Dasmah A, Thor A, Ekestubbe A, Sennerby L, Rasmusson L. Particulate vs. block bone grafts: three-dimensional changes in graft volume after reconstruction of the atrophic maxilla, a 2-year radiographic follow-up. J Craniomaxillofac Surg. 2012 Dec;40(8):654-9. doi: 10.1016/j.jcms.2011.10.032. Epub 2011 Dec 3.
PubMed 22137760AlGhamdi AS. Post-surgical complications of symphyseal block graft with and without soft tissue grafting. Saudi Med J. 2013 Jun;34(6):609-15.
PubMed 23756926Hernandez-Alfaro F, Sancho-Puchades M, Guijarro-Martinez R. Total reconstruction of the atrophic maxilla with intraoral bone grafts and biomaterials: a prospective clinical study with cone beam computed tomography validation. Int J Oral Maxillofac Implants. 2013 Jan-Feb;28(1):241-51. doi: 10.11607/jomi.2405.
PubMed 23377071
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconstruction of Deficient Atrophic Ridges Using Guided Bone Regeneration Technique With Native Collagen Membrane and Polytetrafluoroethylene Membrane (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06746935
- Acronym / sponsor ID
- 0000-0001-6142-0568
- Conditions
- Ridge Augmentation, Bone Augmentation
- Keywords
- ridge augmentation, Polytetrafluoroethylene, native collagen membrane
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 29 Oct 2025 (estimated)
- First posted
- 24 Dec 2024 (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.
patients will be informed of the nature of the research work and informed consent will be obtained then randomized in 2 groups. Mixture 1:1 autogenous and xenogenic bone covered with Polytetrafluoroethylene membrane control group and study group p covered with native collagen membrane.
- Patients of both groups will be subjected to CBCT (diagnostic for upper arch), diagnostic wax-up and stent fabrication.
- Intra operative procedures (for both groups) followed by CBCT will be taken for every patient after 4 months.
Both the study and control group will receive:
- In Recipient site, using 15C blade on Bard Parker handle incision of full thickness mucoperiosteal flap inorder to obtain, three-line pyramidal flap, reflection using mucoperiosteal elevator molt 9.
- The defective site is reevaluated after its primary evaluation on CBCT using UNC (University of North Carolina) periodontal probe and a template is cut using sterile suture pack, prior to donor site preparation.
- Flap advancement using periosteal releasing incision inorder to allow later tension free flap closure.
- In Donor site, mucoperiosteal flap is done, auto chip maker (ACM) is used for autogenous bone harvesting.
- Autogenous particulate bone graft is obtained using auto chip maker bur (ACM), in implant contra 20:1 using surgical motor recommended drilling speed 100 rpm and maximum torque 50 Ncm. as well as, using bone scrapper in push direction.
- Xenogenic bone graft particles (De-proteinized bovine bone mineral small granules (0.25-1 mm). is added to the autogenous bone particles to obtain homogenous mixture ratio 1:1.
- The gold standard is a mixture of autogenous bone containing viable cells and xenogenic bone which has slower rate of resorption is to be placed in recipient decorticated site and covered by PTFE membrane.
- The assemble is to be fixed by titanium bone tacks of diameter 2.5 mm and length 3.5 mm, to avoid micro movements of particulate bone assembly.
- In the Study group: The assemble is going to be covered by resorbable collagen membrane and fixed by tacks.
- Recheck adequate flap advancement by visualizing passive flap approximation, to allow tension free closure.
- Double line closure using horizontal mattress placed 5mm away from flap margins followed by interrupted sutures on top to allow contact area which is preferred to point contact and wound edge eversion.
Detailed description
.General operative procedures The selected patients will be informed of the nature of the research work and informed consent will be obtained then randomized in equal proportions between control group particulate bone mixture 1:1 autogenous and xenogenic bone covered with Polytetrafluoroethylene membrane and study group particulate bone mixture 1:1 autogenous and xenogenic bone covered with native collagen membrane.
- Patients of both groups will be subjected to CBCT (diagnostic for upper arch), diagnostic wax-up and stent fabrication.
- Intra operative procedures (for both groups) followed by CBCT will be taken for every patient after 4 months.
- Infiltration local anesthesia will be given to the patient (Articaine 4% 1:100 000 epinephrine).
Both the study and control group will receive:
- In Recipient site, preparation 1st to obtain, three-line pyramidal flap.
- Flap advancement using periosteal releasing incision.
- In Donor site, auto chip maker (ACM) is used for autogenous bone harvesting and xenogenic bone graft particles mixture ratio 1:1.
- The assemble is to be fixed by titanium bone tacks. In the Study group: The assemble is going to be covered by collagen membrane.
- Double line closure using horizontal mattress placed 5mm away from flap margins followed by interrupted sutures on top to allow contact area which is preferred to point contact and wound edge eversion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group B polytetrafluoroethylene membrane. | Active comparator | Procedure: Polytetrafluoroethylene membrane.Particulate bone mixture 1:1 autogenous and xenogenic bone covered with polytetrafluoroethylene membrane. |
| Study Group A native collagen membrane. | Experimental | Procedure: Collagen membrane.Particulate bone mixture 1:1 autogenous and xenogenic bone covered with native collagen membrane. |
Who may qualify
- Ages
- 20 to 48 years
- Sex
- All
- Healthy volunteers
- Not 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 (5 listed)
- Heavy smokers more than 20 cigarettes per day.
- 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.
- Patients with Metabolic diseases uncontrolled diabetic patients, Glycated hemoglobin (Hb A1c) more than 7 mg\dl.
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 |
|---|---|---|
| Collagen membrane.Particulate bone mixture 1:1 autogenous and xenogenic bone covered with native collagen membrane. | Procedure or surgery | Study Group A native collagen membrane. |
| Polytetrafluoroethylene membrane.Particulate bone mixture 1:1 autogenous and xenogenic bone covered with polytetrafluoroethylene membrane. | Procedure or surgery | Control Group B polytetrafluoroethylene 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
Soft tissue dehiscence.
Time frame: Starting from Week 1. Binary Yes or No.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- 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.
- 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.
- Background: PubMed 19648020Acocella 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.
- Background: PubMed 21834864Spin-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.
- Background: PubMed 22075326Acocella 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.
- 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.
Ahmed M. Youssef, PHD. study director
Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collagen membrane. and Polytetrafluoroethylene membrane. in people with Ridge Augmentation and 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 5 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: looking for participants now, as of the sponsor's last update on 19 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohannad A. Ismail, MSc. (+201222968444 ext. +20, mohannadahmed@hotmail.com), or a site near the patient. 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 NCT06746935, which also lists 20 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 19 Feb 2025.