Bone AugmentationNCT06900933
Reconstruction of Deficient Maxillary Ridges Using Retromolar Blocks With and Without Collagen Membrane
A study testing Onlay bone block covered with 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 quantity? Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Augmentation
- What is being tested?
- Onlay bone block covered with collagen membrane and Onlay bone block without collagen membrane
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 28 May 2025to 15 Feb 2026
- 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 40 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 genders.
- At least missing single tooth.
- Previous Failed Implants.
- Previous Failed Grafting.
Who cannot join
- • Heavy smokers more than 20 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.
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. 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
Niveen A. Askar, Professor, +201001558769 ext. +20, niveen.askar@dentistry.cu.edu.eg
About this study
Official title: Reconstruction of Horizontally Deficient Atrophic Maxillary Ridges Using Retromolar Blocks With and Without Coverage Using Collagen Membrane (Randomized Clinical Trials)
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 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 example Geistlich Bio-Gide or Jason Membrane Botiss.
- Conditions
- Bone Augmentation
- Being tested
- Onlay bone block covered with 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 with collagen membraneProcedure or surgery
Onlay bone block covered with collagen membrane
Onlay bone block without collagen membraneProcedure or surgery
Onlay bone block covered without collagen membrane
| Study group | Role | What they receive |
|---|---|---|
| Study Group A: Retromolar bone block covered with collagen membrane. | Experimental | The onlay bone block harvested from retromolar region and fixed with micro screws, a mixture of autogenous and xenogenic particulate bone graft is going to be packed in between the bone block and recipient site. The assembly is going to be covered with native collagen membrane and fixed with titanium bone tacks. Receives: Procedure: Onlay bone block covered with collagen membrane |
| Control Group B: Retromolar bone block without collagen membrane. | Active comparator | The onlay bone block harvested from retromolar region and fixed with micro screws, a mixture of autogenous and xenogenic particulate bone graft is going to be packed in between the bone block and recipient site. 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 in millimeters.
Measured: At 5 months from ridge augmentation.
Secondary outcomes (1)
Soft Tissue Dehiscence
Exposure of bone block assembly and impaired healing
Measured: Baseline 1st Week. Written Binary Numerical 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 posted28 Mar 2025
- Study start28 May 2025
- Primary completion15 Nov 2025 (estimated)
- Study completion15 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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 (estimated)
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
- NCT06900933
- Sponsor's protocol ID
- 0-0002-9582-5106
- Status last verified
- Jul 2025
- First submitted
- 21 Mar 2025
- Last updated
- 16 Jul 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 12950840Cash and Alex: 20 years of guided bone regeneration in implant dentistry, 2nd ed. (2009).
Urban, I A., Nagrusky H, Lozada JM:
Urban, I A., Nagrusky H, Lozada JM.:
Pellegrino 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 1955919Montazem 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 11117684
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconstruction of Horizontally Deficient Atrophic Maxillary Ridges Using Retromolar Blocks With and Without Coverage Using Collagen Membrane (Randomized Clinical Trials)
- ClinicalTrials.gov ID
- NCT06900933
- Acronym / sponsor ID
- 0-0002-9582-5106
- Conditions
- Bone Augmentation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 28 May 2025 (actual)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 15 Feb 2026 (estimated)
- First posted
- 28 Mar 2025 (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 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 example Geistlich Bio-Gide or Jason Membrane Botiss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group A: Retromolar bone block covered with collagen membrane. | Experimental | Procedure: Onlay bone block covered with collagen membraneThe onlay bone block harvested from retromolar region and fixed with micro screws, a mixture of autogenous and xenogenic particulate bone graft is going to be packed in between the bone block and recipient site. The assembly is going to be covered with native collagen membrane and fixed with titanium bone tacks. |
| Control Group B: Retromolar bone block without collagen membrane. | Active comparator | Procedure: Onlay bone block without collagen membraneThe onlay bone block harvested from retromolar region and fixed with micro screws, a mixture of autogenous and xenogenic particulate bone graft is going to be packed in between the bone block and recipient site. |
Who may qualify
- Ages
- 20 to 40 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 genders.
- At least missing single tooth.
- Previous Failed Implants.
Key exclusion criteria (14 listed)
- • Heavy smokers more than 20 cigarettes per day.
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 with collagen membraneOnlay bone block covered with collagen membrane | Procedure or surgery | Study Group A: Retromolar bone block covered with collagen membrane. |
| Onlay bone block without collagen membraneOnlay bone block covered without collagen membrane | Procedure or surgery | Control Group B: Retromolar bone block without collagen membrane. |
Primary outcome
Quantity of bone gain.
Time frame: At 5 months from ridge augmentation.
Measured using linear measurements from Cone Beam Computed Tomography in millimeters.
1 secondary outcome
Soft Tissue Dehiscence
Time frame: Baseline 1st Week. Written Binary Numerical 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 16 Jul 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.
- BackgroundCash and Alex: 20 years of guided bone regeneration in implant dentistry, 2nd ed. (2009).
- BackgroundUrban, I A., Nagrusky H, Lozada JM:
- BackgroundUrban, I A., Nagrusky H, Lozada JM.:
- 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 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.
- 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.
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 with 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: looking for participants now, as of the sponsor's last update on 16 Jul 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. (01222968444 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: At 5 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 NCT06900933, which also lists 8 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 16 Jul 2025.