Alveolar Bone LossNCT05317039
Piezosurgical Buccal Plate Repositioning Technique for Horizontal Alveolar Ridge Augmentation
A study testing silica-calcium phosphate nanocomposite SCPC and freezed dried bone in people with Alveolar Bone Loss, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Achieving prosthetically driven implant placement is a highly predictable treatment modality with reliable long-term results. Different surgical procedures have been used as a solution for reconstructing of the alveolar ridge with deficient volume. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- silica-calcium phosphate nanocomposite SCPC and freezed dried bone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2021to 30 Jun 2022
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Patients with horizontal atrophy of the posterior mandible with pristine residual alveolar crest width from 2 to 4 mm.
- Augmented area length in the mesial-distal direction of less than 20 mm.
- Adequate physically healthy condition.
Who cannot join
- A systemic disease that would contraindicate oral surgical treatment.
- Treated patients who had undergone therapy involving radiation
- Patients who had received bone resection as part of an oncological treatment after a bone augmentation procedure.
- Patients are subjected to intravenous and/or oral bisphosphonate therapy after the bone augmentation procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Piezosurgical Buccal Plate Repositioning Technique for Horizontal Alveolar Ridge Augmentation Comparing Between Two Different Grafting Materials (a Randomized Clinical Trial)
Achieving prosthetically driven implant placement is a highly predictable treatment modality with reliable long-term results. Different surgical procedures have been used as a solution for reconstructing of the alveolar ridge with deficient volume. In the present study we demonstrate a modified alveolar ridge split technique for horizontal alveolar ridge augmentation (buccal plate repositioning technique) using the piezotome surgery. Evaluation of the effect of silica-calcium phosphate nanocomposite (SCPC) graft material versus demineralized freeze dried bone allograft (DFBA) in horizontal alveolar ridge augmentation before implant insertion will be performed.
- Conditions
- Alveolar Bone Loss
- Being tested
- silica-calcium phosphate nanocomposite SCPC, freezed dried bone
- 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.
silica-calcium phosphate nanocomposite SCPCOther
Patients will be treated with the buccal plate repositioning technique and grafted with SCPC then the grafted defect will be covered with a platelet-rich fibrin membrane.
freezed dried boneOther
Patients will be treated with the buccal plate repositioning technique and grafted using DFDBA. then the grafted defect will be covered with a platelet-rich fibrin membrane.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A will be treated with the buccal plate repositioning technique and grafted with SCPC. Receives: Other: silica-calcium phosphate nanocomposite SCPC |
| Group B | Active comparator | Group B will be similarly managed and grafted using DFDBA Receives: Other: freezed dried bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in alveolar ridge width
All patients will receive a CBCT scan; immediately after surgery and at 6 months post-operatively. The images will be analyzed using OnDemand3D software (Cybermed Inc) CBCT analyzing software and compared to the pre-operative scan for alveolar ridge width evaluation.
Measured: at baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start15 Aug 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (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.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317039
- Sponsor's protocol ID
- Piezosurgery_2021
- Status last verified
- Mar 2022
- First submitted
- 30 Mar 2022
- Last updated
- 7 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Piezosurgical Buccal Plate Repositioning Technique for Horizontal Alveolar Ridge Augmentation Comparing Between Two Different Grafting Materials (a Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT05317039
- Acronym / sponsor ID
- Piezosurgery_2021
- Conditions
- Alveolar Bone Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 7 Apr 2022 (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.
Achieving prosthetically driven implant placement is a highly predictable treatment modality with reliable long-term results. Different surgical procedures have been used as a solution for reconstructing of the alveolar ridge with deficient volume. In the present study we demonstrate a modified alveolar ridge split technique for horizontal alveolar ridge augmentation (buccal plate repositioning technique) using the piezotome surgery. Evaluation of the effect of silica-calcium phosphate nanocomposite (SCPC) graft material versus demineralized freeze dried bone allograft (DFBA) in horizontal alveolar ridge augmentation before implant insertion will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: silica-calcium phosphate nanocomposite SCPCGroup A will be treated with the buccal plate repositioning technique and grafted with SCPC. |
| Group B | Active comparator | Other: freezed dried boneGroup B will be similarly managed and grafted using DFDBA |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with horizontal atrophy of the posterior mandible with pristine residual alveolar crest width from 2 to 4 mm.
- Augmented area length in the mesial-distal direction of less than 20 mm.
- Adequate physically healthy condition.
Key exclusion criteria (4 listed)
- A systemic disease that would contraindicate oral surgical treatment.
- Treated patients who had undergone therapy involving radiation
- Patients who had received bone resection as part of an oncological treatment after a bone augmentation procedure.
- Patients are subjected to intravenous and/or oral bisphosphonate therapy after the bone augmentation procedure.
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 |
|---|---|---|
| silica-calcium phosphate nanocomposite SCPCPatients will be treated with the buccal plate repositioning technique and grafted with SCPC then the grafted defect will be covered with a platelet-rich fibrin membrane. | Other | Group A |
| freezed dried bonePatients will be treated with the buccal plate repositioning technique and grafted using DFDBA. then the grafted defect will be covered with a platelet-rich fibrin membrane. | Other | Group B |
Primary outcome
change in alveolar ridge width
Time frame: at baseline and 6 months
All patients will receive a CBCT scan; immediately after surgery and at 6 months post-operatively. The images will be analyzed using OnDemand3D software (Cybermed Inc) CBCT analyzing software and compared to the pre-operative scan for alveolar ridge width evaluation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
Related trials for Alveolar Bone Loss
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Not yet recruiting
Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation
Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
Not yet recruitingObservational study
Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos
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 silica-calcium phosphate nanocomposite SCPC and freezed dried bone in people with Alveolar Bone Loss, run by Hams Hamed Abdelrahman 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 3 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 7 Apr 2022. 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?
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?
change in alveolar ridge width (time frame: at baseline and 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 7 Apr 2022.