Bone AtrophyNCT03498573
Evaluation of Alveolar Augmentation Using Tunneling Surgical Technique
A study testing tunneling surgical technique in people with Bone Atrophy, run by Hussien Amer Elkady.
Trial summary
patients suffering from anterior maxillary horizontal bone defect the alveolar ridge will be augmented by minimally invasive tunneling technique utilizing MPM as bone graft and patients followed up for 14 weeks . Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bone Atrophy
- What is being tested?
- tunneling surgical technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2018to Apr 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients' age range from 18-60 years.
- Patients with horizontal bone defect in anterior maxillary area.
- Patients should be free from any systemic disease that may affect normal healing of bone and predictable outcome.
Who cannot join
- Patients with systemic diseases as history of radiation therapy or chemotherapy, hematological disorders and autoimmune diseases (may affect normal healing).
Trial locations and contacts
No sites are listed yet.
tarek elghareeb contact
About this study
Official title: Evaluation of Minimally Invasive Alveolar Augmentation Procedure of Anterior Maxillary Ridge Using Tunneling Surgical Technique
patients suffering from anterior maxillary horizontal bone defect the alveolar ridge will be augmented by minimally invasive tunneling technique utilizing MPM as bone graft and patients followed up for 14 weeks .
- Conditions
- Bone Atrophy
- Being tested
- tunneling surgical technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tunneling surgical techniqueOther
Also called mpm
sticky bone prepared by centrifuge patient blood and mixing with xinograft
| Study group | Role | What they receive |
|---|---|---|
| tunneling surgical technique | Experimental | Not described Receives: Other: tunneling surgical technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone formation
bone formation assessed by cone beam ct
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start1 May 2018 (estimated)
- Primary completionJul 2018 (estimated)
- Study completionApr 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 AtrophyStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hussien Amer Elkady
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hussien Amer Elkady, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498573
- Sponsor's protocol ID
- 29004052103937
- Status last verified
- Apr 2018
- First submitted
- 29 Mar 2018
- Last updated
- 13 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nevins ML, Camelo M, Nevins M, Schupbach P, Friedland B, Camelo JM, Kim DM. Minimally invasive alveolar ridge augmentation procedure (tunneling technique) using rhPDGF-BB in combination with three matrices: a case series. Int J Periodontics Restorative Dent. 2009 Aug;29(4):371-83.
PubMed 19639058
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Minimally Invasive Alveolar Augmentation Procedure of Anterior Maxillary Ridge Using Tunneling Surgical Technique
- ClinicalTrials.gov ID
- NCT03498573
- Acronym / sponsor ID
- 29004052103937
- Conditions
- Bone Atrophy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hussien Amer ElkadyUniversity, hospital or other
- Study start
- 1 May 2018 (estimated)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 13 Apr 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.
patients suffering from anterior maxillary horizontal bone defect the alveolar ridge will be augmented by minimally invasive tunneling technique utilizing MPM as bone graft and patients followed up for 14 weeks .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tunneling surgical technique | Experimental | Other: tunneling surgical technique |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients' age range from 18-60 years.
- Patients with horizontal bone defect in anterior maxillary area.
- Patients should be free from any systemic disease that may affect normal healing of bone and predictable outcome.
Key exclusion criteria (1 listed)
- Patients with systemic diseases as history of radiation therapy or chemotherapy, hematological disorders and autoimmune diseases (may affect normal healing).
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 |
|---|---|---|
| tunneling surgical techniqueAlso: mpmsticky bone prepared by centrifuge patient blood and mixing with xinograft | Other | tunneling surgical technique |
Primary outcome
bone formation
Time frame: 14 weeks
bone formation assessed by cone beam ct
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2018.
- Background: PubMed 19639058Nevins ML, Camelo M, Nevins M, Schupbach P, Friedland B, Camelo JM, Kim DM. Minimally invasive alveolar ridge augmentation procedure (tunneling technique) using rhPDGF-BB in combination with three matrices: a case series. Int J Periodontics Restorative Dent. 2009 Aug;29(4):371-83.
- 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.
tarek elghareeb contact
Questions about this trial
What is this clinical trial studying?
A study testing tunneling surgical technique in people with Bone Atrophy, run by Hussien Amer Elkady.
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 1 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 13 Apr 2018. 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. 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 hussien amer elkady, B.D.S (01141178095, elkady_003@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone formation (time frame: 14 weeks). 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 NCT03498573, 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 13 Apr 2018.