Alveolar Ridge AugmentationNCT06206577
Autogenous Grafts for Anterior Maxillary Horizontal Ridge Augmentation
A study testing Horizontal ridge augmentation by symphyseal bone block placed and fixed buccally as onlay graft and Horizontal ridge augmentation by symphyseal bone block interpositioned in space created between buccal and lingual cortex as inlay graft in people with Alveolar Ridge Augmentation, run by Mansoura University at 1 site in Egypt.
Trial summary
The aim of the study was to compare efficacy of autogenous onlay and inlay grafts for anterior maxillary horizontal ridge augmentation. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Ridge Augmentation
- What is being tested?
- Horizontal ridge augmentation by symphyseal bone block placed and fixed buccally as onlay graft and Horizontal ridge augmentation by symphyseal bone block interpositioned in space created between buccal and lingual cortex as inlay graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 26 May 2023
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with missing upper anterior tooth / teeth with horizontal ridge dimension range from 2 to 5 mm (measured 2mm below alveolar crest).
- Adequate vertical height.
- Having good oral hygiene.
- being healthy, with no systemic diseases that might contraindicate receiving a dental implant
- Patients were able to comply with the follow-up and maintenance program
Who cannot join
- Presence of local infection or lesions at site of interest.
- Dental history of bruxism, or other parafunctional habits.
- Uncooperative patients.
- Current chemotherapy or radiotherapy.
- Patients with aggressive periodontal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autogenous Inlay Versus Onlay Grafts for Anterior Maxillary Horizontal Ridge Augmentation
The aim of the study was to compare efficacy of autogenous onlay and inlay grafts for anterior maxillary horizontal ridge augmentation.
Read the detailed description
Autogenous block graft has been used as onlay thin cortical shell and cortico-cancellous particles. The thin cortical shell acts as an autogenous biological membrane that will resist resorption and stabilize the small pieces of particulate bone. The bone block is screwed-in at a distance from the recipient site by means of titanium bone screws, and then the free space under the shell is filled with the particulate bone.
The resultant augmentation somehow resembles an iliac graft, with thick internal cancellous bone and a thin external cortical layer. This leads to an ideal graft, with a high regenerative capacity comparable to iliac bone and a stable regenerated volume with optimum osseointegration potential close to that of mandibular block grafts.
Interpositional grafts have been successfully established in restoring vertical bone height . However much less evidence is present on its use for horizontal augmentation. It is the purpose of this study to assess the efficacy of autogenous onlay corticocancellous block grafts for anterior maxillary horizontal ridge augmentation as compared to onlay block grafts.
- Conditions
- Alveolar Ridge Augmentation
- Being tested
- Horizontal ridge augmentation by symphyseal bone block placed and fixed buccally as onlay graft, Horizontal ridge augmentation by symphyseal bone block interpositioned in space created between buccal and lingual cortex as inlay graft
- Keywords
- onlay grafting, inlay grafting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Horizontal ridge augmentation by symphyseal bone block placed and fixed buccally as onlay graftProcedure or surgery
autogenous bone block harvested from chin area using piezosurgery and fixed buccally in deficient area with fixation screws
Horizontal ridge augmentation by symphyseal bone block interpositioned in space created between buccal and lingual cortex as inlay graftProcedure or surgery
autogenous bone block harvested from chin area using piezosurgery and fixed in bone split created at deficient area with fixation screws
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Seven horizontal anterior maxillary ridge augmentation was done with symphyseal autogenous bone block, which was placed buccally as onlay graft. Receives: Procedure: Horizontal ridge augmentation by symphyseal bone block placed and fixed buccally as onlay graft |
| Group B | Experimental | Seven horizontal anterior maxillary ridge augmentation was done with symphyseal autogenous bone block, which was interpositioned in space created between buccal and lingual cortex as inlay graft. Receives: Procedure: Horizontal ridge augmentation by symphyseal bone block interpositioned in space created between buccal and lingual cortex as inlay graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
horizontal ridge augmentation
CBCT to assess bone gain in mm
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start1 Sep 2020
- Primary completion15 Sep 2022
- Study completion26 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Ridge AugmentationStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Etman Elsayed, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206577
- Sponsor's protocol ID
- A08040820
- Status last verified
- Jan 2024
- First submitted
- 20 Dec 2023
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autogenous Inlay Versus Onlay Grafts for Anterior Maxillary Horizontal Ridge Augmentation
- ClinicalTrials.gov ID
- NCT06206577
- Acronym / sponsor ID
- A08040820
- Conditions
- Alveolar Ridge Augmentation
- Keywords
- onlay grafting, inlay grafting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 26 May 2023 (actual)
- First posted
- 16 Jan 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.
The aim of the study was to compare efficacy of autogenous onlay and inlay grafts for anterior maxillary horizontal ridge augmentation.
Detailed description
Autogenous block graft has been used as onlay thin cortical shell and cortico-cancellous particles. The thin cortical shell acts as an autogenous biological membrane that will resist resorption and stabilize the small pieces of particulate bone. The bone block is screwed-in at a distance from the recipient site by means of titanium bone screws, and then the free space under the shell is filled with the particulate bone.
The resultant augmentation somehow resembles an iliac graft, with thick internal cancellous bone and a thin external cortical layer. This leads to an ideal graft, with a high regenerative capacity comparable to iliac bone and a stable regenerated volume with optimum osseointegration potential close to that of mandibular block grafts.
Interpositional grafts have been successfully established in restoring vertical bone height . However much less evidence is present on its use for horizontal augmentation. It is the purpose of this study to assess the efficacy of autogenous onlay corticocancellous block grafts for anterior maxillary horizontal ridge augmentation as compared to onlay block grafts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Horizontal ridge augmentation by symphyseal bone block placed and fixed buccally as onlay graftSeven horizontal anterior maxillary ridge augmentation was done with symphyseal autogenous bone block, which was placed buccally as onlay graft. |
| Group B | Experimental | Procedure: Horizontal ridge augmentation by symphyseal bone block interpositioned in space created between buccal and lingual cortex as inlay graftSeven horizontal anterior maxillary ridge augmentation was done with symphyseal autogenous bone block, which was interpositioned in space created between buccal and lingual cortex as inlay graft. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with missing upper anterior tooth / teeth with horizontal ridge dimension range from 2 to 5 mm (measured 2mm below alveolar crest).
- Adequate vertical height.
- Having good oral hygiene.
- being healthy, with no systemic diseases that might contraindicate receiving a dental implant
- Patients were able to comply with the follow-up and maintenance program
Key exclusion criteria (5 listed)
- Presence of local infection or lesions at site of interest.
- Dental history of bruxism, or other parafunctional habits.
- Uncooperative patients.
- Current chemotherapy or radiotherapy.
- Patients with aggressive periodontal disease
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 |
|---|---|---|
| Horizontal ridge augmentation by symphyseal bone block placed and fixed buccally as onlay graftautogenous bone block harvested from chin area using piezosurgery and fixed buccally in deficient area with fixation screws | Procedure or surgery | Group A |
| Horizontal ridge augmentation by symphyseal bone block interpositioned in space created between buccal and lingual cortex as inlay graftautogenous bone block harvested from chin area using piezosurgery and fixed in bone split created at deficient area with fixation screws | Procedure or surgery | Group B |
Primary outcome
horizontal ridge augmentation
Time frame: 12 months
CBCT to assess bone gain in mm
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Alveolar Ridge Augmentation
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L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
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Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
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Autogenous and Xenograft Bone Mix in Alveolar Ridge Reconstruction
Horizontal Alveolar Ridge Deficiency
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Comparison of Three Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Horizontal ridge augmentation by symphyseal bone block placed and fixed buccally as onlay graft and Horizontal ridge augmentation by symphyseal bone block interpositioned in space created between buccal and lingual cortex as inlay graft in people with Alveolar Ridge Augmentation, run by Mansoura 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 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: finished, as of the sponsor's last update on 16 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
horizontal ridge augmentation (time frame: 12 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 16 Jan 2024.