Bone AugmentationNCT04775940
Use of Perforated Barrier Membranes and IPRF Nano- Micro Sticky Bone
A study testing Perforated collagen membrane and Occlusive collagen membrane in people with Bone Augmentation, run by Ain Shams University at 1 site in Egypt.
Trial summary
Comparing amount of horizontal bone gain 4 months after alveolar ridge augmentation using IPRF Nano- micro Sticky Bone with perforated collagen membrane versus occlusive barrier membrane by : 1. clinical and Radiographic analysis . 2. Histomorphometric analysis . 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?
- Perforated collagen membrane and Occlusive collagen 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 Mar 2018to 1 Dec 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult patients.
- Both sex, males and females. 3-Age from 20 - 40 years old. 4-All patients will be free from any systemic diseases as evidenced by Burkett's oral medicine health history questionnaire.
- 5-Remaining alveolar bone ≥ 8mm vertically and ≤ 4 mm horizontally. 6-Gingival biotype 1-2mm thickness.
Who cannot join
- Smokers.
- Pregnant and breast feeding females.
- Mentally retarded Patients.
- Presence of hematologic disease.
- Previous radiation, chemotherapy, or immunosuppressive treatments.
- Diabetes mellitus, metabolic bone disease, ongoing treatment with bisphosphonates drugs, or pregnancy.
- Anticoagulant drugs, Endocarditis risk factors, renal and hepatic failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Perforated Barrier Membranes and IPRF Nano- Micro Sticky Bone in Horizontal Alveolar Ridge Augmentation - Controlled Clinical and Histomorphometric Study
Comparing amount of horizontal bone gain 4 months after alveolar ridge augmentation using IPRF Nano- micro Sticky Bone with perforated collagen membrane versus occlusive barrier membrane by :
- clinical and Radiographic analysis .
- Histomorphometric analysis .
- Conditions
- Bone Augmentation
- Being tested
- Perforated collagen membrane, Occlusive collagen membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perforated collagen membraneProcedure or surgery
Horizontal Bone Augmentation using Perforated Collagen Membrane
Occlusive collagen membraneProcedure or surgery
Occlusive collagen membrane
| Study group | Role | What they receive |
|---|---|---|
| Perforated collagen membrane | Experimental | Not described Receives: Procedure: Perforated collagen membrane |
| Occlusive collagen membrane | Active comparator | Not described Receives: Procedure: Occlusive collagen membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal alveolar bone width in mm
Measured By Bone caliber and Cone Beam Computed Tomography (CBCT)
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 posted1 Mar 2021
- Study start1 Mar 2018
- Primary completion1 Sep 2018
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone AugmentationStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775940
- Sponsor's protocol ID
- FDASU-Rec ID021701
- Status last verified
- Feb 2021
- First submitted
- 26 Feb 2021
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Perforated Barrier Membranes and IPRF Nano- Micro Sticky Bone in Horizontal Alveolar Ridge Augmentation - Controlled Clinical and Histomorphometric Study
- ClinicalTrials.gov ID
- NCT04775940
- Acronym / sponsor ID
- FDASU-Rec ID021701
- Conditions
- Bone Augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 1 Mar 2021 (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.
Comparing amount of horizontal bone gain 4 months after alveolar ridge augmentation using IPRF Nano- micro Sticky Bone with perforated collagen membrane versus occlusive barrier membrane by :
- clinical and Radiographic analysis .
- Histomorphometric analysis .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perforated collagen membrane | Experimental | Procedure: Perforated collagen membrane |
| Occlusive collagen membrane | Active comparator | Procedure: Occlusive collagen membrane |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adult patients.
- Both sex, males and females. 3-Age from 20 - 40 years old. 4-All patients will be free from any systemic diseases as evidenced by Burkett's oral medicine health history questionnaire.
- 5-Remaining alveolar bone ≥ 8mm vertically and ≤ 4 mm horizontally. 6-Gingival biotype 1-2mm thickness.
Key exclusion criteria (7 listed)
- Smokers.
- Pregnant and breast feeding females.
- Mentally retarded Patients.
- Presence of hematologic disease.
- Previous radiation, chemotherapy, or immunosuppressive treatments.
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 |
|---|---|---|
| Perforated collagen membraneHorizontal Bone Augmentation using Perforated Collagen Membrane | Procedure or surgery | Perforated collagen membrane |
| Occlusive collagen membraneOcclusive collagen membrane | Procedure or surgery | Occlusive collagen membrane |
Primary outcome
Horizontal alveolar bone width in mm
Time frame: 6 months
Measured By Bone caliber and Cone Beam Computed Tomography (CBCT)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perforated collagen membrane and Occlusive collagen membrane in people with Bone Augmentation, run by Ain Shams 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 3 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: finished, as of the sponsor's last update on 1 Mar 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Horizontal alveolar bone 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 1 Mar 2021.