Posterior Mandible With Deficient Ridge HeightNCT03680118
Vertical Ridge Augmentation With Autogenous Onlay Blocks Combined With Guided Bone Regeneration Versus Autogenous Bone Graft With Titanium Mesh in Posterior Mandible
A study testing autogenous rings with GBR and autogenous graft with ti-mesh in people with Posterior Mandible With Deficient Ridge Height, run by Cairo University.
Trial summary
Atrophic ridge augmentation utilizing guided bone regeneration (GBR) has become a major treatment option to provide optimal bone support for osseointegrated dental implants. GBR was initially employed to treat simple defects, including dehiscence and fenestration defects. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Posterior Mandible With Deficient Ridge Height
- What is being tested?
- autogenous rings with GBR and autogenous graft with ti-mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2018to 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients with edentulous posterior mandible.
- Both sexes.
- No intraoral soft and hard tissue pathology.
- No systemic condition that contraindicate implant placement.
- Residual alveolar bone height more than 6 mm (7-9 mm) and less than 12 mm.
Who cannot join
- Presence of fenestrations or dehiscence of the residual ridge.
- Heavy smokers more than 20 cigarettes per day.
- Patients with systemic disease that may affect normal healing.
- Psychiatric problems
- Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Vertical Ridge Augmentation Using Autogenous Onlay Ring Blocks Combined With Guided Bone Regeneration Using Collagen Membrane Versus Autogenous Bone Graft Only Using Titanium Mesh in Atrophic Posterior Mandibles.
Atrophic ridge augmentation utilizing guided bone regeneration (GBR) has become a major treatment option to provide optimal bone support for osseointegrated dental implants. GBR was initially employed to treat simple defects, including dehiscence and fenestration defects. In addition, GBR has been utilized for horizontal and vertical ridge augmentations and has demonstrated reproducible outcomes, with high implant survival rates and low complication rates. The results of recent clinical and histologic studies of ridge augmentation with GBR indicated that autogenous bone graft may be a suitable material for staged localized ridge augmentation in both horizontal and vertical augmentations. The main advantages of autogenous grafts are their osteogenic, osteoinductive and osteoconductive capabilities. Because of these qualities, autogenous grafts are considered by many to be the gold standard for bone regeneration
Read the detailed description
The GBR Procedure requires to place a barrier between the bone graft and the surrounding soft tissues. This blocks the fast-duplicating connective and epithelial cells from colonizing the regenerating site.
Collagen membranes have been successfully used as a barrier membrane in clinical practice.
They have the advantage of being resorbable and pose less post-operative complications. On the other hand, collagen membranes are not rigid, causing a difficulty in maintaining the vertical height of the particulate bone graft placed onto the ridge.
Alternatively, titanium meshes have been used with success in clinical practice and display both advantages and disadvantages. They provide tenting effect thanks to their rigidity and, being moldable, can be easily given the shape needed to cover the defect.
However they must be removed, not resorbable, require time-consuming shaping and pose complications as flap dehiscence.
Choice of the comparator:
Current studies have shown that using titanium mesh as a barrier to protect the bone graft during GBR can be considered successful in terms of vertical bone gain.
There might be variable in other findings which could be attributed to differences in the methodology, such as using other membranes over the titanium mesh (collagen or PTFE membranes).
- Being tested
- autogenous rings with GBR and autogenous graft with ti-mesh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autogenous rings with GBR and autogenous graft with ti-meshDevice
- Autogenous Onlay ring block harvested from either mandibular ramus or chin will be placed over the defected site and fixed using titanium screws (1.6mm diameter) and then GBR using autogenous particulate will be placed around and over the blocks and covered with a resorbable bilayer collagen membrane (Bio-Gide®, Geistlich, USA)
- Autogenous bone graft will be placed on the defected site and covered by a titanium mesh which will be fixed by titanium screws.
- Flap advancement will be acquired by releasing the mylohyoid muscle attachment from the lingual flap and periosteal releasing incision for the buccal flap to provide tension free closure.
- The flap will then be copiously irrigated with saline in preparation for closure.
- The flap will then be closed using horizontal mattress and interrupted 4/0 polypropylene sutures.
| Study group | Role | What they receive |
|---|---|---|
| autogenous rings with GBR and autogenous graft with ti-mesh | Experimental | Augmentation with autogenous onlay ring blocks covered by guided bone regeneration (GBR) using collagen membrane and autogenous bone graft using titanium mesh (ti-mesh) only Receives: Device: autogenous rings with GBR and autogenous graft with ti-mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
vertical bone gain
the amount of vertical bone gain will be measured using cone beam computed tomography
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start15 Dec 2018 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Mandible With Deficient Ridge HeightStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Shawky Abd El-Moneim Shaheen, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680118
- Sponsor's protocol ID
- cairouimplant masters
- Status last verified
- Nov 2018
- First submitted
- 19 Sep 2018
- Last updated
- 21 Nov 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 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vertical Ridge Augmentation Using Autogenous Onlay Ring Blocks Combined With Guided Bone Regeneration Using Collagen Membrane Versus Autogenous Bone Graft Only Using Titanium Mesh in Atrophic Posterior Mandibles.
- ClinicalTrials.gov ID
- NCT03680118
- Acronym / sponsor ID
- cairouimplant masters
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Dec 2018 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 21 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.
Atrophic ridge augmentation utilizing guided bone regeneration (GBR) has become a major treatment option to provide optimal bone support for osseointegrated dental implants. GBR was initially employed to treat simple defects, including dehiscence and fenestration defects. In addition, GBR has been utilized for horizontal and vertical ridge augmentations and has demonstrated reproducible outcomes, with high implant survival rates and low complication rates. The results of recent clinical and histologic studies of ridge augmentation with GBR indicated that autogenous bone graft may be a suitable material for staged localized ridge augmentation in both horizontal and vertical augmentations. The main advantages of autogenous grafts are their osteogenic, osteoinductive and osteoconductive capabilities. Because of these qualities, autogenous grafts are considered by many to be the gold standard for bone regeneration
Detailed description
The GBR Procedure requires to place a barrier between the bone graft and the surrounding soft tissues. This blocks the fast-duplicating connective and epithelial cells from colonizing the regenerating site.
Collagen membranes have been successfully used as a barrier membrane in clinical practice.
They have the advantage of being resorbable and pose less post-operative complications. On the other hand, collagen membranes are not rigid, causing a difficulty in maintaining the vertical height of the particulate bone graft placed onto the ridge.
Alternatively, titanium meshes have been used with success in clinical practice and display both advantages and disadvantages. They provide tenting effect thanks to their rigidity and, being moldable, can be easily given the shape needed to cover the defect.
However they must be removed, not resorbable, require time-consuming shaping and pose complications as flap dehiscence.
Choice of the comparator:
Current studies have shown that using titanium mesh as a barrier to protect the bone graft during GBR can be considered successful in terms of vertical bone gain.
There might be variable in other findings which could be attributed to differences in the methodology, such as using other membranes over the titanium mesh (collagen or PTFE membranes).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| autogenous rings with GBR and autogenous graft with ti-mesh | Experimental | Device: autogenous rings with GBR and autogenous graft with ti-meshAugmentation with autogenous onlay ring blocks covered by guided bone regeneration (GBR) using collagen membrane and autogenous bone graft using titanium mesh (ti-mesh) only |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adult patients with edentulous posterior mandible.
- Both sexes.
- No intraoral soft and hard tissue pathology.
- No systemic condition that contraindicate implant placement.
- Residual alveolar bone height more than 6 mm (7-9 mm) and less than 12 mm.
Key exclusion criteria (5 listed)
- Presence of fenestrations or dehiscence of the residual ridge.
- Heavy smokers more than 20 cigarettes per day.
- Patients with systemic disease that may affect normal healing.
- Psychiatric problems
- Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
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 |
|---|---|---|
| autogenous rings with GBR and autogenous graft with ti-mesh* Autogenous Onlay ring block harvested from either mandibular ramus or chin will be placed over the defected site and fixed using titanium screws (1.6mm diameter) and then GBR using autogenous particulate will be placed around and over the blocks and covered with a resorbable bilayer collagen membrane (Bio-Gide®, Geistlich, USA) * Autogenous bone graft will be placed on the defected site and covered by a titanium mesh which will be fixed by titanium screws. * Flap advancement will be acquired by releasing the mylohyoid muscle attachment from the lingual flap and periosteal releasing incision for the buccal flap to provide tension free closure. * The flap will then be copiously irrigated with saline in preparation for closure. * The flap will then be closed using horizontal mattress and interrupted 4/0 polypropylene sutures. | Device | autogenous rings with GBR and autogenous graft with ti-mesh |
Primary outcome
vertical bone gain
Time frame: 6 month
the amount of vertical bone gain will be measured using cone beam computed tomography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
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.
Questions about this trial
What is this clinical trial studying?
A study testing autogenous rings with GBR and autogenous graft with ti-mesh in people with Posterior Mandible With Deficient Ridge Height, 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 5 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 21 Nov 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 Mostafa Shawky Shaheen, BDS (+201118153852, dentshaheen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vertical bone gain (time frame: 6 month). 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 21 Nov 2018.