Alveolar Bone LossNCT06450535
Radiographic and Histological Assessment of Autogenous Onlay Block Versus Cortical Shell on Anterior Maxilla
A study testing Autogenous onlay bone block harvesting from retromolar bone in anterior maxilla and Autogenous cortical shell technique from retromolar bone in anterior maxilla in people with Alveolar Bone Loss, run by Cairo University at 1 site in Egypt.
Trial summary
Two groups of patient with horizontally deficient anterior maxilla indicated for bone augmentation ,one will be subjected to autogenous onlay bone block from retromolar bone and the other to cortical shell from retromolar bone also. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- Autogenous onlay bone block harvesting from retromolar bone in anterior maxilla and Autogenous cortical shell technique from retromolar bone in anterior maxilla
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 1 Dec 2025
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients in both sex with partial edentulism of the maxilla and requiring horizontal ridge augmentation
- The ages of the patients ranged from 20 to 60 years.
- The residual ridge width in these patients are less than 4.m
- Sufficient bone in intra-oral donor sites are available (external oblique ridge)
- Patients free from any systemic conditions and bone metabolism diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.
- The vertical level should be in a favourable esthetic appearance with normal inter-arch space
- The minimum number of missing teeth in the anterior maxilla alveolar ridge is one single extracted teeth
Who cannot join
- Subjected to irradiation in the head and neck area less than 1 year before implantation.
- Poor oral hygiene and motivation.
- Uncontrolled diabetes.
- Pregnant or nursing.
- Substance abuse.
- Psychiatric problems or unrealistic expectations.
- Severe bruxism or clenching.
- Immunosuppressed or immunocompromised.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
faculty of oral and dental medicine ,Cairo university
Cairo, Giza Governorate, 12613
MARIA ibrahim nageeb, BSc, 01002402712, maria.nageeb@dentistry.cu.edu.eg
mohamed atef, PhD, 01009612708, mohammedatef@dentistery.cu.edu.eg
About this study
Official title: Radiographic and Histological Assessment of Retromolar Autogenous Onlay Bone Block Versus Cortical Shell for Augmentation of Horizontally Deficient Anterior Maxilla: (Randomized Clinical Trial).
Two groups of patient with horizontally deficient anterior maxilla indicated for bone augmentation ,one will be subjected to autogenous onlay bone block from retromolar bone and the other to cortical shell from retromolar bone also.
Read the detailed description
- Two groups of patients with horizontally deficient anterior maxilla indicated for bone augmentation, the first group will be subjected to autogenous onlay bone block from retromolar bone and the other group to cortical shell from retromolar bone also.
- periodontal therapy will be performed before any procedure and oral hygiene measures will be given to the patient.
- After injecting local anesthesia in the anterior maxillary region a trapezoidal flap will be performed in the area of horizontal bone defect (the recipient site).
- The recipient site will be decorticated and recontoured using a round bone bur for better adaptation of the graft and to improve graft-to-recipient bone contact.
- Bone harvesting will be carried out from retromolar region (the donor site) a crestal incision will be carried out 5 mm below and parallel to the gingival margin of the mandibular molars.
- subperiosteal dissection will be extended to expose the ascending ramus and the retromolar region.
- Using piezoelectric device a crestal cut and two proximal vertical cuts penetrating the cortex of the external oblique ridge will be performed then the inferior cut will be carried out.
- Using a mallet and chisel the bone block will be sheared off.
- The underlying cancellous bone will be gently retrieved and the collected bone will be conserved in sterile saline, followed by suturing the mucosal wound.
- Onlay bone block graft procedure (control group)
- In the first intervention, a bone block harvested from the donor site will be fixed with osteosynthesis titanium screws to the recipient site as an onlay graft to achieve a horizontal enlargement of the alveolar ridge.
- Cortical shell graft procedure (intervention group)
- The harvested cortical plate will be split longitudinally in two parts using a micro-saw and thinned with the bone scraper to achieve a plate of 1 mm thickness.
- The plate will be fixed at a distance from the residual ridge with 2 screws.
- Autogenous bone particles, collected with the bone scraper, were tightly packed into the gap between the plate and the recipient site.
- Radiographic assessment will be achieved by CBCT scan immediately and 4 months postoperatively to evaluate bone regeneration and final horizontal bone width.
- In the two groups, the screws will be removed 4 months postoperatively after final CBCT.
- The bone formed in the gap between the bone segment and the original bone will be measured from the CBCT scan.
- Before the intraoperative installment of the dental implants, bone core biopsies will be retrieved from each patient's recipient sites followed by implant placement.
- Conditions
- Alveolar Bone Loss
- Being tested
- Autogenous onlay bone block harvesting from retromolar bone in anterior maxilla, Autogenous cortical shell technique from retromolar bone in anterior maxilla
- Keywords
- Autogenous onlay bone block, Cortical shell technique
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autogenous onlay bone block harvesting from retromolar bone in anterior maxillaProcedure or surgery
Also called Autogenous onlay block from retomolar bone
Surgical protocol ( retromolar bone harvesting) After injecting local anesthesia a crestal incision is done, from a point on the occlusal surface along the external oblique ridge and extending anteriorly and inferiorly through the buccal mucosa, parallel to the gingival margin of the mandibular molars.
The subperiosteal dissection extend to expose the ascending ramus and the retromolar region With the aid of surgical carbide burs, two proximal vertical cuts penetrating the cortex of the external oblique ridge.
The depth of penetration of the posterior cut did not exceed 2.5 mm to avoid injury to the inferior alveolar nerve.
By using microsaw , an inferior cut of 3.2 mm in depth joining the anterior and posterior vertical cuts was done.
Small perforations of 3-4 mm in depth were performed on the superior aspect of the external oblique ridge using 1 mm drill bur.
Finally, the block was sheared off using a chisel.
Autogenous cortical shell technique from retromolar bone in anterior maxillaProcedure or surgery
Also called Cortical shell technique from retromolar bone
The harvested cortical plate was then split longitudinally in two parts using a microsaw, and thinned with the bone scraper to achieve a plate of 1 mm thickness.
The plate was fixed at a distance from the residual ridge with 2 screws. Autogenous bone particles, collected with the bone scraper, were tightly packed into the gap between the plate and the recipient site.
| Study group | Role | What they receive |
|---|---|---|
| Autogenous onlay block from retromolar bone | Experimental | In the first intervention, a bone block harvested from the donor site was fixed with osteosynthesis titanium screws to the recipient site as an onlay graft to achieve a horizontal enlargement of the alveolar ridge.
● Placement of the bone graft was always guided by an augmentation template Receives: Procedure: Autogenous onlay bone block harvesting from retromolar bone in anterior maxilla |
| Cortical shell technique from retromolar bone | Active comparator | The harvested cortical plate was then split longitudinally in two parts using a microsaw, and thinned with the bone scraper to achieve a plate of 1 mm thickness.
* The plate was fixed at a distance from the residual ridge with 2 screws.
* Autogenous bone particles, collected with the bone scraper, were tightly packed into the gap between the plate and the recipient site. Receives: Procedure: Autogenous cortical shell technique from retromolar bone in anterior maxilla |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiographic analysis
calculation of bone width gain using cone beam computed tomography
Measured: 4 month postoperative
Secondary outcomes (1)
histomorphometric analysis
to assess the bone quality for each technique
Measured: 4 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies 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
- Randomzed cinical trial A trial will be caried out in hosptal of Oral and Maxllolacial surgery department- Faculy of Oral and Dental Medicine Cairo Univerity. Equal randomizaion: participants wih equal probabilites for intervenion Postive controlled :Both groups receiving treatment Parallel group study: Each group of patients receives a single treatment simutaneously
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Ibrahim Nageeb, Cairo University
- Investigators
- mohamed atef, PhD, Study director, faculty of oral and dental medicine,cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450535
- Sponsor's protocol ID
- CEBD_CU_2024_26_1
- Status last verified
- Jun 2024
- First submitted
- 9 May 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic and Histological Assessment of Retromolar Autogenous Onlay Bone Block Versus Cortical Shell for Augmentation of Horizontally Deficient Anterior Maxilla: (Randomized Clinical Trial).
- ClinicalTrials.gov ID
- NCT06450535
- Acronym / sponsor ID
- CEBD_CU_2024_26_1
- Conditions
- Alveolar Bone Loss
- Keywords
- Autogenous onlay bone block, Cortical shell technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 10 Jun 2024 (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.
Two groups of patient with horizontally deficient anterior maxilla indicated for bone augmentation ,one will be subjected to autogenous onlay bone block from retromolar bone and the other to cortical shell from retromolar bone also.
Detailed description
- Two groups of patients with horizontally deficient anterior maxilla indicated for bone augmentation, the first group will be subjected to autogenous onlay bone block from retromolar bone and the other group to cortical shell from retromolar bone also.
- periodontal therapy will be performed before any procedure and oral hygiene measures will be given to the patient.
- After injecting local anesthesia in the anterior maxillary region a trapezoidal flap will be performed in the area of horizontal bone defect (the recipient site).
- The recipient site will be decorticated and recontoured using a round bone bur for better adaptation of the graft and to improve graft-to-recipient bone contact.
- Bone harvesting will be carried out from retromolar region (the donor site) a crestal incision will be carried out 5 mm below and parallel to the gingival margin of the mandibular molars.
- subperiosteal dissection will be extended to expose the ascending ramus and the retromolar region.
- Using piezoelectric device a crestal cut and two proximal vertical cuts penetrating the cortex of the external oblique ridge will be performed then the inferior cut will be carried out.
- Using a mallet and chisel the bone block will be sheared off.
- The underlying cancellous bone will be gently retrieved and the collected bone will be conserved in sterile saline, followed by suturing the mucosal wound.
- Onlay bone block graft procedure (control group)
- In the first intervention, a bone block harvested from the donor site will be fixed with osteosynthesis titanium screws to the recipient site as an onlay graft to achieve a horizontal enlargement of the alveolar ridge.
- Cortical shell graft procedure (intervention group)
- The harvested cortical plate will be split longitudinally in two parts using a micro-saw and thinned with the bone scraper to achieve a plate of 1 mm thickness.
- The plate will be fixed at a distance from the residual ridge with 2 screws.
- Autogenous bone particles, collected with the bone scraper, were tightly packed into the gap between the plate and the recipient site.
- Radiographic assessment will be achieved by CBCT scan immediately and 4 months postoperatively to evaluate bone regeneration and final horizontal bone width.
- In the two groups, the screws will be removed 4 months postoperatively after final CBCT.
- The bone formed in the gap between the bone segment and the original bone will be measured from the CBCT scan.
- Before the intraoperative installment of the dental implants, bone core biopsies will be retrieved from each patient's recipient sites followed by implant placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomzed cinical trial A trial will be caried out in hosptal of Oral and Maxllolacial surgery department- Faculy of Oral and Dental Medicine Cairo Univerity. Equal randomizaion: participants wih equal probabilites for intervenion Postive controlled :Both groups receiving treatment Parallel group study: Each group of patients receives a single treatment simutaneously
| Arm | Type | Receives |
|---|---|---|
| Autogenous onlay block from retromolar bone | Experimental | Procedure: Autogenous onlay bone block harvesting from retromolar bone in anterior maxillaIn the first intervention, a bone block harvested from the donor site was fixed with osteosynthesis titanium screws to the recipient site as an onlay graft to achieve a horizontal enlargement of the alveolar ridge. ● Placement of the bone graft was always guided by an augmentation template |
| Cortical shell technique from retromolar bone | Active comparator | Procedure: Autogenous cortical shell technique from retromolar bone in anterior maxillaThe harvested cortical plate was then split longitudinally in two parts using a microsaw, and thinned with the bone scraper to achieve a plate of 1 mm thickness. * The plate was fixed at a distance from the residual ridge with 2 screws. * Autogenous bone particles, collected with the bone scraper, were tightly packed into the gap between the plate and the recipient site. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients in both sex with partial edentulism of the maxilla and requiring horizontal ridge augmentation
- The ages of the patients ranged from 20 to 60 years.
- The residual ridge width in these patients are less than 4.m
- Sufficient bone in intra-oral donor sites are available (external oblique ridge)
- Patients free from any systemic conditions and bone metabolism diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.
Key exclusion criteria (8 listed)
- Subjected to irradiation in the head and neck area less than 1 year before implantation.
- Poor oral hygiene and motivation.
- Uncontrolled diabetes.
- Pregnant or nursing.
- Substance abuse.
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 onlay bone block harvesting from retromolar bone in anterior maxillaAlso: Autogenous onlay block from retomolar boneSurgical protocol ( retromolar bone harvesting) After injecting local anesthesia a crestal incision is done, from a point on the occlusal surface along the external oblique ridge and extending anteriorly and inferiorly through the buccal mucosa, parallel to the gingival margin of the mandibular molars. The subperiosteal dissection extend to expose the ascending ramus and the retromolar region With the aid of surgical carbide burs, two proximal vertical cuts penetrating the cortex of the external oblique ridge. The depth of penetration of the posterior cut did not exceed 2.5 mm to avoid injury to the inferior alveolar nerve. By using microsaw , an inferior cut of 3.2 mm in depth joining the anterior and posterior vertical cuts was done. Small perforations of 3-4 mm in depth were performed on the superior aspect of the external oblique ridge using 1 mm drill bur. Finally, the block was sheared off using a chisel. | Procedure or surgery | Autogenous onlay block from retromolar bone |
| Autogenous cortical shell technique from retromolar bone in anterior maxillaAlso: Cortical shell technique from retromolar boneThe harvested cortical plate was then split longitudinally in two parts using a microsaw, and thinned with the bone scraper to achieve a plate of 1 mm thickness. The plate was fixed at a distance from the residual ridge with 2 screws. Autogenous bone particles, collected with the bone scraper, were tightly packed into the gap between the plate and the recipient site. | Procedure or surgery | Cortical shell technique from retromolar bone |
Primary outcome
radiographic analysis
Time frame: 4 month postoperative
calculation of bone width gain using cone beam computed tomography
1 secondary outcome
histomorphometric analysis
Time frame: 4 months postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Breakage of internal maxillary distractor: considerable complication of maxillary distraction osteogenesisLink provided by the sponsor.
- The outcome of intraoral onlay block bone grafts on alveolar ridge augmentations: A systematic reviewLink provided by the sponsor.
- Lateral Ridge Augmentation Using Autogenous Block Grafts and Guided Bone Regeneration: A 10-Year Prospective Case Series StudyLink provided by the sponsor.
- Long-Term Results of Peri-implant Conditions in Periodontally Compromised Patients Following Lateral Bone Augmentation.Link provided by the sponsor.
- Augmentation of the sinus floor with mandibular bone block and simultaneous implantation: a 6-year clinical investigationLink provided by the sponsor.
- "Secure and effective stabilization of different sized autogenous bone grafts."Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
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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.
mohamed atef, PhD study director
faculty of oral and dental medicine,cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autogenous onlay bone block harvesting from retromolar bone in anterior maxilla and Autogenous cortical shell technique from retromolar bone in anterior maxilla in people with Alveolar Bone Loss, run by Cairo 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 7 inclusion and 8 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 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact maria ibrahim nageeb, BSc (01002402712, maria.nageeb@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radiographic analysis (time frame: 4 month postoperative). 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 Jun 2024.