Maxilla AtrophyNCT06831214
Assessment of Bone Gain Following Composite Graft Rehabilitation of Horizontal Maxilla Atrophy With Sausage Technique Utilizing (Pericardial) Collagen Membrane
A study testing (pericardial) collagen membrane and periosteal Membrane harvested from anterior iliac bone in people with Maxilla Atrophy, run by Cairo University at 1 site in Egypt.
Trial summary
This study designed to assess amount of bone gain following composite graft rehabilitation of horizontal maxilla atrophy with sausage technique utilizing (pericardial) collagen membrane versus Periosteal membrane harvested from the iliac crest in 6 months. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxilla Atrophy
- What is being tested?
- (pericardial) collagen membrane and periosteal Membrane harvested from anterior iliac bone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 1 Aug 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range (18-60 years)
- Patients with unilateral or bilateral horizontal atrophy in maxilla with minimum 1 quadrant.
- No intervention done previously on the donor and host sides.
- No sex predilection
Who cannot join
- Syndromic patients.
- bone metabolism \& systemic diseases.
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
Cairo University
Cairo
Manaf O Alhabshi, Msc, 01016027252, manaf.alhabshi@dentistry.cu.edu.eg
About this study
Official title: Assessment of Bone Gain Following Composite Graft Rehabilitation of Horizontal Maxilla Atrophy With Sausage Technique Utilizing (Pericardial) Collagen Membrane Versus Periosteal Membrane Harvested From the Iliac Crest A Randomized Clinical Trial
This study designed to assess amount of bone gain following composite graft rehabilitation of horizontal maxilla atrophy with sausage technique utilizing (pericardial) collagen membrane versus Periosteal membrane harvested from the iliac crest in 6 months.
Read the detailed description
Edentulous Maxillary ridges are a growing challenge worldwide. According to a fact sheet released by the World Health Organization (WHO) in 2022. teeth loss can be attributed to many conditions, mainly advanced dental caries, and severe periodontal disease. But pathology trauma and infection are other potential causes. Substantial studies have shown Dental implants as an excellent treatment choice with predictable long-term results.
However, to guarantee the success of implant stability at the time of insertion, a sufficient amount of bone width is robust. As known that bone surrounding extracted teeth resorb in all directions. This leads to horizontal and vertical bone volume loss reaching up to 50% in width reduction which compromises dental implant insertion. Cawood and Howell in 1988 categorized the degrees of edentulous ridge atrophy into six categories, emphasizing category IV atrophies which are known as "knife-edge" ridge, present a serious horizontal defect, making dental implant placement a challenge.
The challenge of bone defects augmentation primarily lies in the insufficient bone volume at the implant site, which can negatively impact the success of dental implants. Severe horizontal bone defects, such as those classified as "knife-edge" ridges, present significant obstacles for effective implant placement. Sausage Technique: Specifically designed for cases with severely thin ridges, this technique utilizes a collagen membrane stabilized with titanium pins to secure the bone graft. This helps prevent the migration or collapse of graft particles, promoting better bone gain and healing. Still some limitation of this technique including possibility of the collagen membrane becoming exposed during the healing process, which can compromise the regenerative outcome. Limited Bone Gain: In some cases, the amount of bone gain achieved may not meet the expectations, particularly in severely atrophic ridges, which can lead to the need for additional augmentation procedures. A study by Fernando V, et al showed that recipient sites augmented with autogenous bone grafts and preserved periosteal membranes maintained an average bucco-lingual width of 8.1 mm after augmentation, which was significantly greater than the baseline width of 3.2 mm. This augmented width was maintained at 98% after an average follow-up of 2.9 years. Another study by Kubota and Shirasuna evaluates the effectiveness of free periosteum in secondary bone grafting for maxillary alveolar clefts.
Results indicate that 97.1% of patients receiving free periosteum achieved significant vertical bone formation, compared to 79.5% in the control group. While the free-periosteum group experienced a higher rate of postoperative wound dehiscence. The rationale of the study is to evaluate the effectiveness of a combination of autogenous bone and an organic bovine bone-derived mineral (ABBM) for horizontal ridge augmentation using sausage technique utilizing (pericardial) collagen membrane versus Periosteal membrane harvested from the iliac crest. The study aimed to Assess bone gain in insufficient maxillary alveolar ridge width, particularly in patients with knife-edge ridges, to facilitate successful dental implant placement.
- Conditions
- Maxilla Atrophy
- Being tested
- (pericardial) collagen membrane, periosteal Membrane harvested from anterior iliac bone
- Keywords
- collagen membrane, Periosteal membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(pericardial) collagen membraneOther
bone gain following composite graft rehabilitation of horizontal maxilla atrophy with sausage technique utilizing (pericardial) collagen membrane
periosteal Membrane harvested from anterior iliac boneOther
The choice of comparators in clinical studies involving guided bone regeneration (GBR) often includes both nonresorbable and resorbable membranes. Resorbable membranes have demonstrated better soft tissue compatibility compared to nonresorbable options, making them a preferred choice in many cases. For instance, studies have shown that using an organic bovine bone-derived mineral (ABBM) in conjunction with a rapidly resorbing natural collagen membrane is effective for horizontal ridge augmentation, as evidenced by positive histologic outcomes.
| Study group | Role | What they receive |
|---|---|---|
| pericardial collagen membrane | Experimental | Sausage Technique: Specifically designed for cases with severely thin ridges, this technique utilizes a collagen membrane stabilized with titanium pins to secure the bone graft. This helps prevent the migration or collapse of graft particles, promoting better bone gain and healing Receives: Other: (pericardial) collagen membrane |
| periosteal Membrane harvested from anterior iliac bone | Active comparator | The choice of comparators in clinical studies involving guided bone regeneration (GBR) often includes both nonresorbable and resorbable membranes. Resorbable membranes have demonstrated better soft tissue compatibility compared to nonresorbable options, making them a preferred choice in many cases. For instance, studies have shown that using an organic bovine bone-derived mineral (ABBM) in conjunction with a rapidly resorbing natural collagen membrane is effective for horizontal ridge augmentation, as evidenced by positive histologic outcomes. Receives: Other: periosteal Membrane harvested from anterior iliac bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal bone gain
Bone caliper intra-operative and at time of implant placement CBCT, preoperative, immediate to assess amount of bone gain postoperative
Measured: 6 months
Secondary outcomes (1)
Percentage of newly formed bone
Bone core biopsy from the augmentation site with Histomorphometric analysis to assess amount of bone gain
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start1 Feb 2025
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxilla AtrophyStudies 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
- Participant
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manaf Omar Alhabshi, Cairo University
- Investigators
- Manaf O Alhabshi, Msc, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831214
- Sponsor's protocol ID
- 1-25
- Status last verified
- Feb 2025
- First submitted
- 30 Jan 2025
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Bone Gain Following Composite Graft Rehabilitation of Horizontal Maxilla Atrophy With Sausage Technique Utilizing (Pericardial) Collagen Membrane Versus Periosteal Membrane Harvested From the Iliac Crest A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06831214
- Acronym / sponsor ID
- 1-25
- Conditions
- Maxilla Atrophy
- Keywords
- collagen membrane, Periosteal membrane
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 18 Feb 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.
This study designed to assess amount of bone gain following composite graft rehabilitation of horizontal maxilla atrophy with sausage technique utilizing (pericardial) collagen membrane versus Periosteal membrane harvested from the iliac crest in 6 months.
Detailed description
Edentulous Maxillary ridges are a growing challenge worldwide. According to a fact sheet released by the World Health Organization (WHO) in 2022. teeth loss can be attributed to many conditions, mainly advanced dental caries, and severe periodontal disease. But pathology trauma and infection are other potential causes. Substantial studies have shown Dental implants as an excellent treatment choice with predictable long-term results.
However, to guarantee the success of implant stability at the time of insertion, a sufficient amount of bone width is robust. As known that bone surrounding extracted teeth resorb in all directions. This leads to horizontal and vertical bone volume loss reaching up to 50% in width reduction which compromises dental implant insertion. Cawood and Howell in 1988 categorized the degrees of edentulous ridge atrophy into six categories, emphasizing category IV atrophies which are known as "knife-edge" ridge, present a serious horizontal defect, making dental implant placement a challenge.
The challenge of bone defects augmentation primarily lies in the insufficient bone volume at the implant site, which can negatively impact the success of dental implants. Severe horizontal bone defects, such as those classified as "knife-edge" ridges, present significant obstacles for effective implant placement. Sausage Technique: Specifically designed for cases with severely thin ridges, this technique utilizes a collagen membrane stabilized with titanium pins to secure the bone graft. This helps prevent the migration or collapse of graft particles, promoting better bone gain and healing. Still some limitation of this technique including possibility of the collagen membrane becoming exposed during the healing process, which can compromise the regenerative outcome. Limited Bone Gain: In some cases, the amount of bone gain achieved may not meet the expectations, particularly in severely atrophic ridges, which can lead to the need for additional augmentation procedures. A study by Fernando V, et al showed that recipient sites augmented with autogenous bone grafts and preserved periosteal membranes maintained an average bucco-lingual width of 8.1 mm after augmentation, which was significantly greater than the baseline width of 3.2 mm. This augmented width was maintained at 98% after an average follow-up of 2.9 years. Another study by Kubota and Shirasuna evaluates the effectiveness of free periosteum in secondary bone grafting for maxillary alveolar clefts.
Results indicate that 97.1% of patients receiving free periosteum achieved significant vertical bone formation, compared to 79.5% in the control group. While the free-periosteum group experienced a higher rate of postoperative wound dehiscence. The rationale of the study is to evaluate the effectiveness of a combination of autogenous bone and an organic bovine bone-derived mineral (ABBM) for horizontal ridge augmentation using sausage technique utilizing (pericardial) collagen membrane versus Periosteal membrane harvested from the iliac crest. The study aimed to Assess bone gain in insufficient maxillary alveolar ridge width, particularly in patients with knife-edge ridges, to facilitate successful dental implant placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pericardial collagen membrane | Experimental | Other: (pericardial) collagen membraneSausage Technique: Specifically designed for cases with severely thin ridges, this technique utilizes a collagen membrane stabilized with titanium pins to secure the bone graft. This helps prevent the migration or collapse of graft particles, promoting better bone gain and healing |
| periosteal Membrane harvested from anterior iliac bone | Active comparator | Other: periosteal Membrane harvested from anterior iliac boneThe choice of comparators in clinical studies involving guided bone regeneration (GBR) often includes both nonresorbable and resorbable membranes. Resorbable membranes have demonstrated better soft tissue compatibility compared to nonresorbable options, making them a preferred choice in many cases. For instance, studies have shown that using an organic bovine bone-derived mineral (ABBM) in conjunction with a rapidly resorbing natural collagen membrane is effective for horizontal ridge augmentation, as evidenced by positive histologic outcomes. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age range (18-60 years)
- Patients with unilateral or bilateral horizontal atrophy in maxilla with minimum 1 quadrant.
- No intervention done previously on the donor and host sides.
- No sex predilection
Key exclusion criteria (2 listed)
- Syndromic patients.
- bone metabolism \& systemic diseases.
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 |
|---|---|---|
| (pericardial) collagen membranebone gain following composite graft rehabilitation of horizontal maxilla atrophy with sausage technique utilizing (pericardial) collagen membrane | Other | pericardial collagen membrane |
| periosteal Membrane harvested from anterior iliac boneThe choice of comparators in clinical studies involving guided bone regeneration (GBR) often includes both nonresorbable and resorbable membranes. Resorbable membranes have demonstrated better soft tissue compatibility compared to nonresorbable options, making them a preferred choice in many cases. For instance, studies have shown that using an organic bovine bone-derived mineral (ABBM) in conjunction with a rapidly resorbing natural collagen membrane is effective for horizontal ridge augmentation, as evidenced by positive histologic outcomes. | Other | periosteal Membrane harvested from anterior iliac bone |
Primary outcome
Horizontal bone gain
Time frame: 6 months
Bone caliper intra-operative and at time of implant placement CBCT, preoperative, immediate to assess amount of bone gain postoperative
1 secondary outcome
Percentage of newly formed bone
Time frame: 6 months
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 18 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Maxilla Atrophy
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
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The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos
Recruiting
Two-Stage Transcrestal Sinus Lift With Osseodensification: Allograft vs Autogenous-Xenograft
Severely Atrophic Posterior Maxilla
Recruiting
Alveolar Ridge Preservation (ARP) in the Posterior Maxilla After the Extraction of Maxillary Molars
Alveolar Bone Loss
RecruitingPhase 2/3
Assessment of a New Enhanced Xenograft in Open Maxillary Sinus Augmentation
Maxillary Sinus Floor Augmentation, Maxillary Sinus Elevation
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.
Manaf O Alhabshi, Msc principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (pericardial) collagen membrane and periosteal Membrane harvested from anterior iliac bone in people with Maxilla Atrophy, 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 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: looking for participants now, as of the sponsor's last update on 18 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 Manaf O Alhabshi (01016027252, manaf.alhabshi@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Horizontal bone gain (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2025.