Bone ResorptionNCT03052387
Vertical Augmentation Using Onlay Versus Inlay Autogenous Graft With Simultaneous Implant Placement.
A study testing assigned intervention in people with Bone Resorption, run by Cairo University.
Trial summary
Using autogenous Chin block for vertical augmentation with simultaneous implant placement at anterior maxilla region comparing between the Onlay and Inlay grafting techniques. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Resorption
- What is being tested?
- assigned intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Mar 2017to Dec 2017
- 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- * Patients with partially edentulous anterior maxillary ridges.
- Patients were free from any systemic disease that interferes with bone healing.
- Absence of local pathosis at anterior maxillary area.
- No history of any grafting procedure at the designated edentulous ridge.
- The edentulous ridge vertical dimension was less than 10 mm measured from the alveolar crest to the nasal floor (i.e.ridge had vertical inadequacy) with normal horizontal alveolar dimension or patient with Increased Inter-Arch Space.
Who cannot join
- * Patient with fully dentulous maxilla.
- Pregnant females.
- Presence of bad habits (severe bruxism, clenching).
- Systemic diseases that may interfere with bone healing.e.g. uncontrolled Diabetes.
About this study
Official title: Assessment of Vertical Bone Augmentation Using Autogenous Onlay Versus Inlay Grafting Techniques With Simultaneous Implant Placement in the Anterior Maxillary Area on Patient's Esthetic Satisfaction : A Randomized Clinical Trial
Using autogenous Chin block for vertical augmentation with simultaneous implant placement at anterior maxilla region comparing between the Onlay and Inlay grafting techniques.
Read the detailed description
to study the vertical augmentation with simultaneous implant placement at anterior maxillary region.
- P: Patient requires implant at anterior maxillary ridge with vertical deficiency.
- I:Inlay Sandwich Technique with immediate implant placement.
- C:Onlay autogenous graft immediate implant placement.
- O:Outcome name Measuring device Measuring unit
Primary outcome: Vertical bone gain CBCT Millimeter
-Secondary outcome(a): Crestal bone loss CBCT Millimeter
- Conditions
- Bone Resorption
- Being tested
- assigned intervention
- Medical subject headings
- Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assigned interventionOther
- Local anesthesia with vasoconstrictor(V.C) used for hemostasis. chin block graft
- Scrubbing and draping of the patient will be carried out in a standard fashion using betadine surgical scrub.
- The donor site is usually the chin area, its approached using local anesthesia with VC at symphysis region.
- Low vestibular incision exposing the symphysis area to the inferior border of the mandible.
- Using fissure bur to harvest the graft for the defect.
- Closure using vicryl 3-O sutures.
| Study group | Role | What they receive |
|---|---|---|
| control | Placebo comparator | * Crestal pyramidal flap will be done with 2 releasing incisions for adequate exposure.
* Buccal\& palatal full reflection for adequate exposure and to avoid the interference between the onlay graft and the residual bone.
* Decortication of the bone bed to increase the blood supply to the onlay graft.
* The block graft harvested from the chin is placed crestal to the residual ridge and stabilized in place using dental implant immediately.
* Periosteal incisions are usually needed to allow tension free sutures.
* Vicryl 3/0 sutures for closer.
* augmentin 1g twice daily for 5 days.
* catflam 50g twice daily for 3 days Receives: Other: assigned intervention |
| Comparator | Active comparator | * Crestal incision with labial flap reflected leaving the palatal tissues without elevation.
* Marking of the 3 bony cuts ( 2 vertical cuts \& 1 horizontal cut ) using fine fissure bur in the form of perforations along the cuts position.
* Drilling of pilot drill and first drill only.
* 3 full thickness cuts will be performed (2 vertical stop cuts will be made by using the tungsten carbide disc at the distal ends of the horizontal bony cut on the facial surface of alveolar ridge.
* splitting osteotomes are used and mallet to complete the splitting of the bony segment.
* After bony separation the rectangular bony segment (transport segment) will be mobilized occlusally and pedicled on the palatal mucoperiosteum.
* The autogenous block graft harvested from the chin area is placed in the space gained under the mobile bony segment.
* Drilling through the bony segment and the block graft.
* Immediate implant placement
chin graft block dental implants Receives: Other: assigned intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
vertical Bone gain
- The nasal floor will be used as a fixed reference by adjusting the cross sectional long axis in the center of the area of interest and bisecting it (showing the buccolingual dimension).
- All the patients will wear the radiographic dentures with radiopaque material (barium sulphate mixed with acrylic powder) filling the teeth at the area of interest to ensure that the calculations were taken at the same region.
- On the cross sectional view of CBCT and at each proposed implant site, a line will be drawn starting from the crest of the ridge till the nasal floor. The height will be recorded preoperatively, immediately (1 week) and 6 months postoperatively.the difference between them in millimeters will be recorded.
Measured: 6 months
Secondary outcomes (1)
crestal bone loss
crestal bone loss around the implant will be measured in millimeter after 6 months
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 Feb 2017
- Study startMar 2017 (estimated)
- Primary completionAug 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone ResorptionStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Ahmed Hassan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052387
- Sponsor's protocol ID
- CairoAMI-CG
- Status last verified
- Feb 2017
- First submitted
- 7 Feb 2017
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: assessment of vertical ridge augmentation using autogenous Onlay versus Inlay Bone Grafting techniques in the anterior maxilla.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Vertical Bone Augmentation Using Autogenous Onlay Versus Inlay Grafting Techniques With Simultaneous Implant Placement in the Anterior Maxillary Area on Patient's Esthetic Satisfaction : A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03052387
- Acronym / sponsor ID
- CairoAMI-CG
- Conditions
- Bone Resorption
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2017 (estimated)
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 14 Feb 2017 (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.
Using autogenous Chin block for vertical augmentation with simultaneous implant placement at anterior maxilla region comparing between the Onlay and Inlay grafting techniques.
Detailed description
to study the vertical augmentation with simultaneous implant placement at anterior maxillary region.
- P: Patient requires implant at anterior maxillary ridge with vertical deficiency.
- I:Inlay Sandwich Technique with immediate implant placement.
- C:Onlay autogenous graft immediate implant placement.
- O:Outcome name Measuring device Measuring unit
Primary outcome: Vertical bone gain CBCT Millimeter
-Secondary outcome(a): Crestal bone loss CBCT Millimeter
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Placebo comparator | Other: assigned intervention* Crestal pyramidal flap will be done with 2 releasing incisions for adequate exposure. * Buccal\& palatal full reflection for adequate exposure and to avoid the interference between the onlay graft and the residual bone. * Decortication of the bone bed to increase the blood supply to the onlay graft. * The block graft harvested from the chin is placed crestal to the residual ridge and stabilized in place using dental implant immediately. * Periosteal incisions are usually needed to allow tension free sutures. * Vicryl 3/0 sutures for closer. * augmentin 1g twice daily for 5 days. * catflam 50g twice daily for 3 days |
| Comparator | Active comparator | Other: assigned intervention* Crestal incision with labial flap reflected leaving the palatal tissues without elevation. * Marking of the 3 bony cuts ( 2 vertical cuts \& 1 horizontal cut ) using fine fissure bur in the form of perforations along the cuts position. * Drilling of pilot drill and first drill only. * 3 full thickness cuts will be performed (2 vertical stop cuts will be made by using the tungsten carbide disc at the distal ends of the horizontal bony cut on the facial surface of alveolar ridge. * splitting osteotomes are used and mallet to complete the splitting of the bony segment. * After bony separation the rectangular bony segment (transport segment) will be mobilized occlusally and pedicled on the palatal mucoperiosteum. * The autogenous block graft harvested from the chin area is placed in the space gained under the mobile bony segment. * Drilling through the bony segment and the block graft. * Immediate implant placement chin graft block dental implants |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- * Patients with partially edentulous anterior maxillary ridges.
- The edentulous ridge vertical dimension was less than 10 mm measured from the alveolar crest to the nasal floor (i.e.ridge had vertical inadequacy) with normal horizontal alveolar dimension or patient with Increased Inter-Arch Space.
Key exclusion criteria (4 listed)
- * Patient with fully dentulous maxilla.
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 |
|---|---|---|
| assigned intervention* Local anesthesia with vasoconstrictor(V.C) used for hemostasis. chin block graft * Scrubbing and draping of the patient will be carried out in a standard fashion using betadine surgical scrub. * The donor site is usually the chin area, its approached using local anesthesia with VC at symphysis region. * Low vestibular incision exposing the symphysis area to the inferior border of the mandible. * Using fissure bur to harvest the graft for the defect. * Closure using vicryl 3-O sutures. | Other | Comparator, control |
Primary outcome
vertical Bone gain
Time frame: 6 months
* The nasal floor will be used as a fixed reference by adjusting the cross sectional long axis in the center of the area of interest and bisecting it (showing the buccolingual dimension). * All the patients will wear the radiographic dentures with radiopaque material (barium sulphate mixed with acrylic powder) filling the teeth at the area of interest to ensure that the calculations were taken at the same region. * On the cross sectional view of CBCT and at each proposed implant site, a line will be drawn starting from the crest of the ridge till the nasal floor. The height will be recorded preoperatively, immediately (1 week) and 6 months postoperatively.the difference between them in millimeters will be recorded.
1 secondary outcome
crestal bone loss
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 23 Feb 2017.
- Individual participant dataSharing planned: No. assessment of vertical ridge augmentation using autogenous Onlay versus Inlay Bone Grafting techniques in the anterior maxilla.
Related trials for Bone Resorption
Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos
Enrolling by invitation
Investigation of the Effect of Horizontal Platelet Rich Fibrin Placed in Tooth Extraction Sockets on Bone Formation
Tooth Loss, Dental Implant Failed
RecruitingPhase 1
Veverimer to Decrease Net Acid Excretion and Bone Resorption in Adults With Osteopenia
Osteopenia
RecruitingObservational study
A Prospective Natural History Study of Lymphatic Anomalies
Lymphatic Diseases, Lymphatic Abnormalities
Recruiting
Effect of Collagen Membrane on Ridge Preservation
Dehiscence, Tooth Extraction
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 assigned intervention in people with Bone Resorption, 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 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 23 Feb 2017. 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. Some participants in this study may receive a placebo. 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?
vertical Bone gain (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 23 Feb 2017.