Implant ComplicationNCT03663439
Modified Shell Technique Versus Onlay Bone Graft in Anterior Maxilla
A study testing modified shell technique in people with Implant Complication, run by Cairo University.
Trial summary
Amount of bone volume and (width and height): Will be measured using linear measurements from CBCT after 6 month from implant insertion. Will be measured using Histometric analysis of bone area percent sampling from recipient site after 6 months. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Implant Complication
- What is being tested?
- modified shell technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 16 Sep 2018to 16 Feb 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patients with atrophic anterior maxilla
- No intraoral soft and hard tissue pathology
- No systemic condition that contraindicate implant placement
- Both sexes.
Who cannot join
- Heavy smokers more than 20 cigarettes per day.
- Patients with systemic disease that may affect normal healing.
- Psychiatric problems
- Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.
About this study
Official title: Evaluation of Modified Shell Technique Versus Onlay Bone Graft for Reconstruction of Atrophic Anterior Maxilla
Amount of bone volume and (width and height):
Will be measured using linear measurements from CBCT after 6 month from implant insertion.
Will be measured using Histometric analysis of bone area percent sampling from recipient site after 6 months.
Read the detailed description
Augmentation of insufficient bone volume can be brought about by different methods, including, particulate and block grafting materials, Guided Bone Regeneration with or without growth and differentiation factors, ridge splitting, expansion and distraction osteogenesis, either alone or in combination. These techniques may be used for horizontal/vertical ridge augmentation
Autograft is considered as the Gold Standard for bone transplantation and various studies have shown efficacy for it. It is osteogenic, osteoconductive and osteoinductive. Autografts can be derived from extra oral source (iliac crest, ribs) or intraoral source (chin, ramus). They can be used in block or particulate form. Corticocancellous block grafts are preferred because of enhanced revascularization of the cancellous portion, and mechanical support and rigidity of the cortical portion, which ensures optimal ridge augmentation.
Fouad Khoury presented a three-dimensional (3D) reconstruction technique for atrophic ridges and complicated vertical bone defects using mandibular bone block graft "the Gold standard". There are several possibilities for augmentation of bone volume depending on situation, indication and adequate diagnosis; the treatment options can be extended from minimally invasive procedures with locally harvested bone grafts in local anesthesia, to very sophisticated grafting techniques for 3D bone reconstruction with extra oral harvested bone grafts. Khoury reported that his ascending ramus grafts is almost 5 times more than chin grafts
- Conditions
- Implant Complication
- Being tested
- modified shell technique
- Keywords
- anterior augmentation,shell technique,onlay bone graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified shell techniqueProcedure or surgery
divided block of bone into two shells and grafting one shell in anterior maxilla
| Study group | Role | What they receive |
|---|---|---|
| modified shell technique | Experimental | block of bone from the mandibular ramus divided into two shells ,grafting one shell in the anterior maxilla to increase width Receives: Procedure: modified shell technique |
| onlay bone graft | Active comparator | grafting block of bone from the mandibular ramus in the atrophic anterior maxilla Receives: Procedure: modified shell technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histomorphometric
Type of bone formed by graft, after 3 months biopsy from the bone formed
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start16 Sep 2018 (estimated)
- Primary completion20 Sep 2018 (estimated)
- Study completion16 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant ComplicationStudies 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
- Model description
- control group (modified shell technique) study group (onlay bone graft)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr hisham mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663439
- Sponsor's protocol ID
- 1552016
- Status last verified
- Sep 2018
- First submitted
- 5 Sep 2018
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Modified Shell Technique Versus Onlay Bone Graft for Reconstruction of Atrophic Anterior Maxilla
- ClinicalTrials.gov ID
- NCT03663439
- Acronym / sponsor ID
- 1552016
- Conditions
- Implant Complication
- Keywords
- anterior augmentation,shell technique,onlay bone graft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 16 Sep 2018 (estimated)
- Primary completion
- 20 Sep 2018 (estimated)
- Study completion
- 16 Feb 2019 (estimated)
- First posted
- 10 Sep 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.
Amount of bone volume and (width and height):
Will be measured using linear measurements from CBCT after 6 month from implant insertion.
Will be measured using Histometric analysis of bone area percent sampling from recipient site after 6 months.
Detailed description
Augmentation of insufficient bone volume can be brought about by different methods, including, particulate and block grafting materials, Guided Bone Regeneration with or without growth and differentiation factors, ridge splitting, expansion and distraction osteogenesis, either alone or in combination. These techniques may be used for horizontal/vertical ridge augmentation
Autograft is considered as the Gold Standard for bone transplantation and various studies have shown efficacy for it. It is osteogenic, osteoconductive and osteoinductive. Autografts can be derived from extra oral source (iliac crest, ribs) or intraoral source (chin, ramus). They can be used in block or particulate form. Corticocancellous block grafts are preferred because of enhanced revascularization of the cancellous portion, and mechanical support and rigidity of the cortical portion, which ensures optimal ridge augmentation.
Fouad Khoury presented a three-dimensional (3D) reconstruction technique for atrophic ridges and complicated vertical bone defects using mandibular bone block graft "the Gold standard". There are several possibilities for augmentation of bone volume depending on situation, indication and adequate diagnosis; the treatment options can be extended from minimally invasive procedures with locally harvested bone grafts in local anesthesia, to very sophisticated grafting techniques for 3D bone reconstruction with extra oral harvested bone grafts. Khoury reported that his ascending ramus grafts is almost 5 times more than chin grafts
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- control group (modified shell technique) study group (onlay bone graft)
| Arm | Type | Receives |
|---|---|---|
| modified shell technique | Experimental | Procedure: modified shell techniqueblock of bone from the mandibular ramus divided into two shells ,grafting one shell in the anterior maxilla to increase width |
| onlay bone graft | Active comparator | Procedure: modified shell techniquegrafting block of bone from the mandibular ramus in the atrophic anterior maxilla |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- patients with atrophic anterior maxilla
- No intraoral soft and hard tissue pathology
- No systemic condition that contraindicate implant placement
- Both sexes.
Key exclusion criteria (4 listed)
- Heavy smokers more than 20 cigarettes per day.
- Patients with systemic disease that may affect normal healing.
- Psychiatric problems
- Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.
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 |
|---|---|---|
| modified shell techniquedivided block of bone into two shells and grafting one shell in anterior maxilla | Procedure or surgery | modified shell technique, onlay bone graft |
Primary outcome
Histomorphometric
Time frame: 3 months
Type of bone formed by graft, after 3 months biopsy from the bone formed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing modified shell technique in people with Implant Complication, 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 4 inclusion and 4 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 10 Sep 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?
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?
Histomorphometric (time frame: 3 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 10 Sep 2018.