Atrophied Anterior Maxillary RidgesPhase 2NCT03628157
GBR With Ptfe With Bovine Bone With and Without Autogenous
A Phase 2 study testing Geistlich Bio-Oss® bovine bone alone in people with Atrophied Anterior Maxillary Ridges, run by Cairo University at 1 site in Egypt.
Trial summary
Ridge Augmentation in Atrophic Anterior Maxillary Ridges with a Titanium Reinforced Polytetraflouroethelene Membrane and Anorganic Bovine Bone-Derived Mineral in intervention group and Anorganic Bovine Bone-Derived Mineralwith Particulated Autogenous Bone Chips in control group. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrophied Anterior Maxillary Ridges
- What is being tested?
- Geistlich Bio-Oss® bovine bone alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2018to Aug 2019
- Phase
- Phase 2
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, 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
1 site in 1 country.
Egypt1 site
Faculty of Oral and Dental Medicine
Giza, 12613
hassan A ahmed, bachelor, (+202) 23642938, hassan.ahmed@dentistry.cu.edu.eg
About this study
Official title: Ridge Augmentation in Atrophic Anterior Maxillary Ridges With a Titanium Reinforced Polytetraflouroethelene Membrane and Anorganic Bovine Bone-Derived Mineral With and Without Particulated Autogenous Bone Chips
Ridge Augmentation in Atrophic Anterior Maxillary Ridges with a Titanium Reinforced Polytetraflouroethelene Membrane and Anorganic Bovine Bone-Derived Mineral in intervention group and Anorganic Bovine Bone-Derived Mineralwith Particulated Autogenous Bone Chips in control group.
CBCT will be done before surgery, immediate after surgery and 6 month to compare the bone gain in mm.
Read more
Bone sample will be collected during exposure after 6 month of surgery by trephine bur to assess the bone quality through histo-morphometric analysis in order to determine the size, shape and orientation of the bony trabeculae, the size and porosity of the bony cortex in addition to the new bone/ bone substitute ratio
- 1ry outcome: Amount of bone gain will be measured using linear measurements from CBCT immediate after surgery and after 6 month.
- 2ry outcome: a bone sample will be collected and analyzed under histo-morphometric analysis.
- Conditions
- Atrophied Anterior Maxillary Ridges
- Being tested
- Geistlich Bio-Oss® bovine bone alone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geistlich Bio-Oss® bovine bone aloneOther
Ridge augmentation by titanium reinforced polytetraflouroethelene membrane and anorganic bovine bone derived mineral alone
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | using a bio-oss bovine bone alone Receives: Other: Geistlich Bio-Oss® bovine bone alone |
| control | Active comparator | using a bio-oss bovine bone with autogenous bone ratio 1:1 Receives: Other: Geistlich Bio-Oss® bovine bone alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of bone gain (height and width in mm)
will be measured using linear measurements from CBCT
Measured: 6 months
Secondary outcomes (1)
a bone sample will be collected and analyzed under histo-morphometric analysis. (no of bone cells in cubic mm)
a bone sample will be collected and analyzed under 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 posted14 Aug 2018
- Study startSep 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophied Anterior Maxillary RidgesStudies 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherif osama hegazy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628157
- Sponsor's protocol ID
- Bone augmentation
- Status last verified
- Aug 2018
- First submitted
- 7 Aug 2018
- Last updated
- 14 Aug 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ridge Augmentation in Atrophic Anterior Maxillary Ridges With a Titanium Reinforced Polytetraflouroethelene Membrane and Anorganic Bovine Bone-Derived Mineral With and Without Particulated Autogenous Bone Chips
- ClinicalTrials.gov ID
- NCT03628157
- Acronym / sponsor ID
- Bone augmentation
- Conditions
- Atrophied Anterior Maxillary Ridges
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 14 Aug 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.
Ridge Augmentation in Atrophic Anterior Maxillary Ridges with a Titanium Reinforced Polytetraflouroethelene Membrane and Anorganic Bovine Bone-Derived Mineral in intervention group and Anorganic Bovine Bone-Derived Mineralwith Particulated Autogenous Bone Chips in control group.
CBCT will be done before surgery, immediate after surgery and 6 month to compare the bone gain in mm.
Bone sample will be collected during exposure after 6 month of surgery by trephine bur to assess the bone quality through histo-morphometric analysis in order to determine the size, shape and orientation of the bony trabeculae, the size and porosity of the bony cortex in addition to the new bone/ bone substitute ratio
- 1ry outcome: Amount of bone gain will be measured using linear measurements from CBCT immediate after surgery and after 6 month.
- 2ry outcome: a bone sample will be collected and analyzed under histo-morphometric analysis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: Geistlich Bio-Oss® bovine bone aloneusing a bio-oss bovine bone alone |
| control | Active comparator | Other: Geistlich Bio-Oss® bovine bone aloneusing a bio-oss bovine bone with autogenous bone ratio 1:1 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- • Patients with atrophied anterior maxillary ridge area.
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 |
|---|---|---|
| Geistlich Bio-Oss® bovine bone aloneRidge augmentation by titanium reinforced polytetraflouroethelene membrane and anorganic bovine bone derived mineral alone | Other | control, intervention |
Primary outcome
Amount of bone gain (height and width in mm)
Time frame: 6 months
will be measured using linear measurements from CBCT
1 secondary outcome
a bone sample will be collected and analyzed under histo-morphometric analysis. (no of bone cells in cubic mm)
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 14 Aug 2018.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Geistlich Bio-Oss® bovine bone alone in people with Atrophied Anterior Maxillary Ridges, 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 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 14 Aug 2018. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 sherif hegazy, bachelor (00201008183867, shekosoa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of bone gain (height and width in mm) (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 14 Aug 2018; AzTrials last refreshed its copy on 6 Nov 2026.