Ridge DeficiencyNCT03607006
Ridge Augmentation Using Patient Specific PEEK Sheets vs. Autogenous Bone Shell Technique.
A study testing Patient specific PEEK sheets and Autogenous bone shell in people with Ridge Deficiency, run by Ola Alaa El-Din Abd El-Monem Mohamed at 1 site in Egypt.
Trial summary
Comparative study to assess the ability of the patient specific PEEK sheets in ridge augmentation with using mixed Autogenous/Xenogenic bone graft vs the Bone Shell Technique regarding the time, accuracy and donor site morbidity . Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ridge Deficiency
- What is being tested?
- Patient specific PEEK sheets and Autogenous bone shell
- 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
- 10 Jul 2018to 31 Mar 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with deficient alveolar bone in the anterior maxilla.
- Patient seeking fixed prosthesis at the anterior maxillary region.
- Highly motivated patients.
- Good oral hygiene.
- Patients willing for the surgical procedure and follow-up, with an informed consent.
- Bounded anterior maxilla cases.
Who cannot join
- Medically compromised patients.
- Uncooperative patients.
- Poor oral hygiene.
- Periodontal diseases.
- No history of any grafting procedure at the designated edentulous ridge.Criteria
- Patients with any diseases that compromise bone or soft tissue healing.
- Patients with no local pathosis that interfere with the bone healing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 3D Ridge Augmentation in the Anterior Maxillary Region Using Patient Specific Polyether Ether Ketone (PEEK) Sheets vs. Autogenous Bone Shell Technique. A Randomized Clinical Trial: Comparative Study
Comparative study to assess the ability of the patient specific PEEK sheets in ridge augmentation with using mixed Autogenous/Xenogenic bone graft vs the Bone Shell Technique regarding the time, accuracy and donor site morbidity .
Read the detailed description
A- Intervention Group (Patient specific PEEK sheets)
- Preoperative Computed tomography will be done to the patients.
- Using special software, 3D models will be obtained and used to design the custom made PEEK sheets. The final STL (Standard Tessellation Language) files will be sent to the lab to be milled/printed.
- Autogenous bone graft will be taken from Chin/Retromolar graft and will be mixed with xenogenic bone graft in 1:1 ratio.
- After bone exposure, the ridge will be decorticated and the prefabricated PEEK sheets will be fixed with titanium screws and the space between the sheets and the ridge will be filled with the prepared bone graft.
- Wounds closure will be done.
- CT scan will be done postoperative.
- After 6 months another CT scan will be done for evaluation and comparison. Then the titanium screws will be removed and implants will be placed.
B- Control Group (Autogenous bone shell technique)
- Preoperative Computed tomography will be done to the patients
- Bone graft will be harvested from the chin/retromolar region and a cortico- cancellous bone block will be obtained then divided into two pieces used as the shells.
- The bone shells will be trimmed and adjusted to the recipient site and the remaining bone will be milled and mixed with Xenogenic bone graft with ratio 1:1
- The bone shells will be anchored in the host bone with titanium screws and the space between the shells and the alveolar bone will be filled by the bone graft mix.
- Wounds closure will be done.
- CT scan will be done.
- After 6 months another CT scan will be done for evaluation and comparison. Then the patient will go for micro screws removal along with implant placement.
- Conditions
- Ridge Deficiency
- Being tested
- Patient specific PEEK sheets, Autogenous bone shell
- Keywords
- Anterior maxillary region, Patient specific, Autogenous bone shell, PEEK, Ridge augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient specific PEEK sheetsProcedure or surgery
Computer aided sheet design
Autogenous bone shellProcedure or surgery
autogenous retromolar/chin bone graft
| Study group | Role | What they receive |
|---|---|---|
| Patient specific PEEK sheets | Experimental | Patient specific PEEK sheets will be fixed with titanium screws and act as containment system for the mixed autogenous/xenogenic bone graft that will fill the gap between the sheets and the ridge . Receives: Procedure: Patient specific PEEK sheets |
| Autogenous bone shell technique | Active comparator | Bone shells will be fixed with titanium screws to the ridge and mixed autogenous/xenogenic bone graft will fill the gap between the shells and the ridge . Receives: Procedure: Autogenous bone shell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Questionnaire will be used to evaluate the satisfaction , measuring unit Binary (YES/NO)
Measured: 8 months
Secondary outcomes (4)
Bone gain
Bone gain will be evaluated using the Computed tomography , measuring unit (mm)
Measured: 4-6 months post-operative
Bone quality
Histological analysis of bone core biopsy , measuring unit Osteon number
Measured: 4-6 months post-operative
Soft tissue reaction
Clinical evaluation by caliber to measure thickness of keratinized mucosa ,measuring unit (mm)
Measured: 4-6 months postoperative
Intraoperative time
Using stop watch to measure the operative time
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start10 Jul 2018
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ridge DeficiencyStudies of the same condition, open and under way.
- 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
- * A randomized clinical trial. * Parallel group study. * A trial will be carried out in hospital of Oral and Maxillofacial surgery department - Faculty of Oral and Dental Medicine - Cairo University . * Equal randomization : participants with equal probabilities for intervention. * Positive controlled : Both groups receiving treatment.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ola Alaa El-Din Abd El-Monem Mohamed
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Ola Alaa El-Din Abd El-Monem Mohamed, Cairo University
- Investigators
- Ahmed A Brakart, PhD, Study director, Cairo UniversityMohamed M Shaker, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607006
- Sponsor's protocol ID
- CEBD-CU-2018-07-16
- Status last verified
- Apr 2024
- First submitted
- 23 Jul 2018
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mounir M, Morsy OAE, Amer H, Mounir S, Gibaly A. Assessment of bone quality using buccal and palatal autogenous cortical shells harvested from two different mandibular donor sites for maxillary alveolar ridge augmentation: a histomorphometric randomized clinical trial. Oral Maxillofac Surg. 2021 Jun;25(2):263-269. doi: 10.1007/s10006-020-00924-w. Epub 2020 Nov 24.
PubMed 33231752
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Ridge Augmentation in the Anterior Maxillary Region Using Patient Specific Polyether Ether Ketone (PEEK) Sheets vs. Autogenous Bone Shell Technique. A Randomized Clinical Trial: Comparative Study
- ClinicalTrials.gov ID
- NCT03607006
- Acronym / sponsor ID
- CEBD-CU-2018-07-16
- Conditions
- Ridge Deficiency
- Keywords
- Anterior maxillary region, Patient specific, Autogenous bone shell, PEEK, Ridge augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Ola Alaa El-Din Abd El-Monem MohamedUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 31 Jul 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.
Comparative study to assess the ability of the patient specific PEEK sheets in ridge augmentation with using mixed Autogenous/Xenogenic bone graft vs the Bone Shell Technique regarding the time, accuracy and donor site morbidity .
Detailed description
A- Intervention Group (Patient specific PEEK sheets)
- Preoperative Computed tomography will be done to the patients.
- Using special software, 3D models will be obtained and used to design the custom made PEEK sheets. The final STL (Standard Tessellation Language) files will be sent to the lab to be milled/printed.
- Autogenous bone graft will be taken from Chin/Retromolar graft and will be mixed with xenogenic bone graft in 1:1 ratio.
- After bone exposure, the ridge will be decorticated and the prefabricated PEEK sheets will be fixed with titanium screws and the space between the sheets and the ridge will be filled with the prepared bone graft.
- Wounds closure will be done.
- CT scan will be done postoperative.
- After 6 months another CT scan will be done for evaluation and comparison. Then the titanium screws will be removed and implants will be placed.
B- Control Group (Autogenous bone shell technique)
- Preoperative Computed tomography will be done to the patients
- Bone graft will be harvested from the chin/retromolar region and a cortico- cancellous bone block will be obtained then divided into two pieces used as the shells.
- The bone shells will be trimmed and adjusted to the recipient site and the remaining bone will be milled and mixed with Xenogenic bone graft with ratio 1:1
- The bone shells will be anchored in the host bone with titanium screws and the space between the shells and the alveolar bone will be filled by the bone graft mix.
- Wounds closure will be done.
- CT scan will be done.
- After 6 months another CT scan will be done for evaluation and comparison. Then the patient will go for micro screws removal along with implant placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * A randomized clinical trial. * Parallel group study. * A trial will be carried out in hospital of Oral and Maxillofacial surgery department - Faculty of Oral and Dental Medicine - Cairo University . * Equal randomization : participants with equal probabilities for intervention. * Positive controlled : Both groups receiving treatment.
| Arm | Type | Receives |
|---|---|---|
| Patient specific PEEK sheets | Experimental | Procedure: Patient specific PEEK sheetsPatient specific PEEK sheets will be fixed with titanium screws and act as containment system for the mixed autogenous/xenogenic bone graft that will fill the gap between the sheets and the ridge . |
| Autogenous bone shell technique | Active comparator | Procedure: Autogenous bone shellBone shells will be fixed with titanium screws to the ridge and mixed autogenous/xenogenic bone graft will fill the gap between the shells and the ridge . |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients with deficient alveolar bone in the anterior maxilla.
- Patient seeking fixed prosthesis at the anterior maxillary region.
- Highly motivated patients.
- Good oral hygiene.
- Patients willing for the surgical procedure and follow-up, with an informed consent.
Key exclusion criteria (7 listed)
- Medically compromised patients.
- Uncooperative patients.
- Poor oral hygiene.
- Periodontal diseases.
- No history of any grafting procedure at the designated edentulous ridge.Criteria
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 |
|---|---|---|
| Patient specific PEEK sheetsComputer aided sheet design | Procedure or surgery | Patient specific PEEK sheets |
| Autogenous bone shellautogenous retromolar/chin bone graft | Procedure or surgery | Autogenous bone shell technique |
Primary outcome
Patient satisfaction
Time frame: 8 months
Questionnaire will be used to evaluate the satisfaction , measuring unit Binary (YES/NO)
4 secondary outcomes
Bone gain
Time frame: 4-6 months post-operative
Bone quality
Time frame: 4-6 months post-operative
Soft tissue reaction
Time frame: 4-6 months postoperative
Intraoperative time
Time frame: Intraoperative
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 9 Apr 2024.
- Derived from this study: PubMed 33231752Mounir M, Morsy OAE, Amer H, Mounir S, Gibaly A. Assessment of bone quality using buccal and palatal autogenous cortical shells harvested from two different mandibular donor sites for maxillary alveolar ridge augmentation: a histomorphometric randomized clinical trial. Oral Maxillofac Surg. 2021 Jun;25(2):263-269. doi: 10.1007/s10006-020-00924-w. Epub 2020 Nov 24.
- Individual participant dataSharing planned: No
Related trials for Ridge Deficiency
Not yet recruiting
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
Not yet recruitingPhase 4
Combating Related Epidemics in HCV
HIV - Human Immunodeficiency Virus, Hepatitis B Virus (HBV)
Not yet recruiting
Comparison of Two Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
Not yet recruiting
Shell Technique for Implant Site Development
Ridge Augmentation, 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.
Ahmed A Brakart, PhD study director
Cairo University
Mohamed M Shaker, PhD study director
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 Patient specific PEEK sheets and Autogenous bone shell in people with Ridge Deficiency, run by Ola Alaa El-Din Abd El-Monem Mohamed 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 6 inclusion and 7 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 9 Apr 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?
Patient satisfaction (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03607006, which also lists 1 linked publication.
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 9 Apr 2024.