Bone Resorption DisorderNCT03731416
Guided Bone Regeneration in Atrophic Anterior Maxillary Ridges
A study testing GBR by xenograft and autogenous bone in people with Bone Resorption Disorder, run by Cairo University.
Trial summary
This study is aiming to evaluate clinically, radiographically ,and histologically GBR using collagen membrane in combination with a mixture of ABBM and autogenous particulated bone compared to collagen membrane with ABBM in atrophied anterior maxilla. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Resorption Disorder
- What is being tested?
- GBR by xenograft and autogenous bone
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 12 Nov 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with atrophied anterior maxillary ridge area.
- Age: 18 years and older.
- Both sexes.
- No intraoral soft and hard tissue pathology.
- No systemic condition that contraindicate bone augmentation
Who cannot join
- • Heavy smokers more than 20 cigarettes per day.(32)
- Patients with systemic disease that may affect normal healing.
- Psychiatric problems.
- Disorders to bone augmentation are related to history of radiation therapy to the head and neck neoplasia.
- Pregnant or nursing women.
- Patients with uncontrolled diabetes mellitus, rheumatoid arthritis or osteoporosis.
- Patient with previous history of radiotherapy.
Trial locations and contacts
No sites are listed yet.
hossam Elbaha contact
About this study
Official title: Ridge Augmentation in Atrophic Anterior Maxillary Ridges With Native Collagen Membrane and Anorganic Bovine Bone Derived Mineral With and Without Particulated Autogenous Bone Chips
This study is aiming to evaluate clinically, radiographically ,and histologically GBR using collagen membrane in combination with a mixture of ABBM and autogenous particulated bone compared to collagen membrane with ABBM in atrophied anterior maxilla.
Read the detailed description
Guided bone regeneration (GBR) has been proposed as a possible alternative for patients with severe horizontal bone atrophy, to overcome the drawback of bone blocks techniques.6,8 To protect and prevent the invasion of the clot by nonosteogenic cells, maintaining an adequate biological space for the regeneration of bone tissue, the use of resorbable membranes, in combination with autologous or heterologous particulate bone have been proposed. Expanded polytetrafluoroethylene (e-PTFE) membranes are the most used non-resorbable membranes with the longest published follow-up, considering them the gold standard in the reconstructions of major horizontal bone defects. However, a second surgery is needed to remove them and they may get exposed in the oral cavity and contaminate with possible infection and graft loss. Conversely, the resorbable membranes most advantages are an ability to merge with the host tissues, as well as a rapid resorption in case of exposure, thereby reducing the risk of bacterial contamination. Resorbable membranes in combination with particulated anorganic bovine bone (ABB) can be used for the augmentation of horizontally deficient ridges. Particulated autogenous bone can be mixed with bone substitutes to add more osteogenic factors.
- Conditions
- Bone Resorption Disorder
- Being tested
- GBR by xenograft and autogenous bone
- Keywords
- GBR, autogenous bone, xenograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GBR by xenograft and autogenous boneProcedure or surgery
Ridge augmentation by native collagen membrane and mix of anorganic bovine bone derived mineral with particulated autogenous bone chips (ratio 1:1).
| Study group | Role | What they receive |
|---|---|---|
| GBR by xenograft | Placebo comparator | * Patients of both groups will be subjected to CBCT (diagnostic for upper arch).
* Intra operative procedures (for both groups) followed by CBCT will be taken for every patient.
* Local anesthesia will be given to the patient.
* Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures.
* Flap will be done.
* In the study group: bone decortication will be done using surgical round bur, anorganic bovine bone derived mineral will be packed then covered at the defected area by a native collagen membrane which will be stabilized by tacks.
* • The site will then be copiously irrigated with saline in preparation for closure.
* The flap will then be closed using interrupted 4/0 resorbable sutures. Receives: Procedure: GBR by xenograft and autogenous bone |
| GBR by xenograft ,autogenous bone | Active comparator | Intervention In the control group:first crestal incision then two vertical incisions by blade 15c,full thickness flap reflection, bone decortication will be done using surgical round bur, autogenous bone will be harvested by trephine bur ,mixed 1:1 with anorganic bovine bone derived mineral and packed at the defected area(atrophic maxilla) then covered by a native collagen membrane which will be stabilized by tacks.Then The flap will then be closed using interrupted 4/0 resorbable sutures. Receives: Procedure: GBR by xenograft and autogenous bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height and width of bone gained
Height and width of bone gained in mm by CBCT
Measured: 6 months
Secondary outcomes (1)
Bone area percentage
Bone area percentage % by Histo-morphometric analysis
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 posted6 Nov 2018
- Study start1 Oct 2019 (estimated)
- Primary completion1 Nov 2019 (estimated)
- Study completion12 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone Resorption DisorderStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients will be randomly divided into 2 equal groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hossam samir mohamed ahmed elbaha, Cairo University
- Investigators
- hossam Elbaha, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731416
- Sponsor's protocol ID
- Guided bone regeneration
- Status last verified
- Aug 2019
- First submitted
- 3 Nov 2018
- Last updated
- 30 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Meloni SM, Jovanovic SA, Urban I, Canullo L, Pisano M, Tallarico M. Horizontal Ridge Augmentation using GBR with a Native Collagen Membrane and 1:1 Ratio of Particulated Xenograft and Autologous Bone: A 1-Year Prospective Clinical Study. Clin Implant Dent Relat Res. 2017 Feb;19(1):38-45. doi: 10.1111/cid.12429. Epub 2016 Jun 9.
PubMed 27283920
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ridge Augmentation in Atrophic Anterior Maxillary Ridges With Native Collagen Membrane and Anorganic Bovine Bone Derived Mineral With and Without Particulated Autogenous Bone Chips
- ClinicalTrials.gov ID
- NCT03731416
- Acronym / sponsor ID
- Guided bone regeneration
- Conditions
- Bone Resorption Disorder
- Keywords
- GBR, autogenous bone, xenograft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 12 Nov 2019 (estimated)
- First posted
- 6 Nov 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.
This study is aiming to evaluate clinically, radiographically ,and histologically GBR using collagen membrane in combination with a mixture of ABBM and autogenous particulated bone compared to collagen membrane with ABBM in atrophied anterior maxilla.
Detailed description
Guided bone regeneration (GBR) has been proposed as a possible alternative for patients with severe horizontal bone atrophy, to overcome the drawback of bone blocks techniques.6,8 To protect and prevent the invasion of the clot by nonosteogenic cells, maintaining an adequate biological space for the regeneration of bone tissue, the use of resorbable membranes, in combination with autologous or heterologous particulate bone have been proposed. Expanded polytetrafluoroethylene (e-PTFE) membranes are the most used non-resorbable membranes with the longest published follow-up, considering them the gold standard in the reconstructions of major horizontal bone defects. However, a second surgery is needed to remove them and they may get exposed in the oral cavity and contaminate with possible infection and graft loss. Conversely, the resorbable membranes most advantages are an ability to merge with the host tissues, as well as a rapid resorption in case of exposure, thereby reducing the risk of bacterial contamination. Resorbable membranes in combination with particulated anorganic bovine bone (ABB) can be used for the augmentation of horizontally deficient ridges. Particulated autogenous bone can be mixed with bone substitutes to add more osteogenic factors.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The patients will be randomly divided into 2 equal groups
| Arm | Type | Receives |
|---|---|---|
| GBR by xenograft | Placebo comparator | Procedure: GBR by xenograft and autogenous bone* Patients of both groups will be subjected to CBCT (diagnostic for upper arch). * Intra operative procedures (for both groups) followed by CBCT will be taken for every patient. * Local anesthesia will be given to the patient. * Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures. * Flap will be done. * In the study group: bone decortication will be done using surgical round bur, anorganic bovine bone derived mineral will be packed then covered at the defected area by a native collagen membrane which will be stabilized by tacks. * • The site will then be copiously irrigated with saline in preparation for closure. * The flap will then be closed using interrupted 4/0 resorbable sutures. |
| GBR by xenograft ,autogenous bone | Active comparator | Procedure: GBR by xenograft and autogenous boneIntervention In the control group:first crestal incision then two vertical incisions by blade 15c,full thickness flap reflection, bone decortication will be done using surgical round bur, autogenous bone will be harvested by trephine bur ,mixed 1:1 with anorganic bovine bone derived mineral and packed at the defected area(atrophic maxilla) then covered by a native collagen membrane which will be stabilized by tacks.Then The flap will then be closed using interrupted 4/0 resorbable sutures. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with atrophied anterior maxillary ridge area.
- Age: 18 years and older.
- Both sexes.
- No intraoral soft and hard tissue pathology.
- No systemic condition that contraindicate bone augmentation
Key exclusion criteria (7 listed)
- • Heavy smokers more than 20 cigarettes per day.(32)
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 |
|---|---|---|
| GBR by xenograft and autogenous boneRidge augmentation by native collagen membrane and mix of anorganic bovine bone derived mineral with particulated autogenous bone chips (ratio 1:1). | Procedure or surgery | GBR by xenograft, GBR by xenograft ,autogenous bone |
Primary outcome
Height and width of bone gained
Time frame: 6 months
Height and width of bone gained in mm by CBCT
1 secondary outcome
Bone area percentage
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
- Results publication: PubMed 27283920Meloni SM, Jovanovic SA, Urban I, Canullo L, Pisano M, Tallarico M. Horizontal Ridge Augmentation using GBR with a Native Collagen Membrane and 1:1 Ratio of Particulated Xenograft and Autologous Bone: A 1-Year Prospective Clinical Study. Clin Implant Dent Relat Res. 2017 Feb;19(1):38-45. doi: 10.1111/cid.12429. Epub 2016 Jun 9.
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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.
hossam Elbaha contact
hossam Elbaha study chair
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing GBR by xenograft and autogenous bone in people with Bone Resorption Disorder, 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 5 inclusion and 7 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 30 Aug 2019. 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. Some participants in this study may receive a placebo. 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?
Contact Hossam Elbaha, Master (+201277750002, hossam_elbaha@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Height and width of bone gained (time frame: 6 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 NCT03731416, which also lists 1 linked publication.
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 30 Aug 2019.