Alveolar Bone ResorptionPhase 1RGDNCT07028606
Vertical Ridge Augmentation Using Computer-guided Sandwich Osteotomy Technique
A Phase 1 study testing Sandwich technique with xenograft, collagen membrane and simultaneous implant placement. and Sandwich technique with (RGD), xenograft, collagen membrane and simultaneous implant placement. in people with Alveolar Bone Resorption, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Researcher will introduce the trial to patients and provide full explanation of its aim and benefits in Arabic language. Patients will then be able to have an informed discussion with the researcher. Researcher will obtain written consent from patients willing to participate in the trial Read more about this study
- Who is it for?
- Ages 30 to 45 years
- Conditions the study is for
- Alveolar Bone Resorption
- What is being tested?
- Sandwich technique with xenograft, collagen membrane and simultaneous implant placement. and Sandwich technique with (RGD), xenograft, collagen membrane and simultaneous implant placement.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 9 May 2024to 10 Jun 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 30 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults (age 30-45) with vertical ridge deficiency.
- Patients with maxillary vertical ridge deficiency 4-8mm according to Cologne Classification of Alveolar Ridge Defects (CCARD).
- Patients with good oral hygiene.
- Free from systemic diseases that may influence the outcome of the therapy.
Who cannot join
- Systemic conditions which are generally considered to be a contraindication to implant surgery which included but not limited to: osteoporosis, uncontrolled diabetes.
- Pregnant or lactating females
- Current or former smokers.
- Patient treated by immunosuppressive chemotherapy or radio therapy,
- Allergy to any material or medication used in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Arginine - Glycine - Aspartic Acid (RGD) Hydrogel on Vertical Ridge Augmentation Using Computer-guided Sandwich Osteotomy Technique, With Xenograft and Simultaneous Implant Placement
Researcher will introduce the trial to patients and provide full explanation of its aim and benefits in Arabic language. Patients will then be able to have an informed discussion with the researcher. Researcher will obtain written consent from patients willing to participate in the trial
Read the detailed description
This protocol and the template informed consent form will be reviewed by the Ethics Committee of Scientific Research -Faculty of Oral and Dental Medicine- Al-Azhar University.
- Conditions
- Alveolar Bone Resorption
- Being tested
- Sandwich technique with xenograft, collagen membrane and simultaneous implant placement., Sandwich technique with (RGD), xenograft, collagen membrane and simultaneous implant placement.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sandwich technique with xenograft, collagen membrane and simultaneous implant placement.Procedure or surgery
All surgery will be in upper arch, for sandwich osteotomy technique, after local anesthesia, crestal incision with buccal intrasulcular incisions will be done extending at least one tooth mesial and distal to the implant associated site. Full thickness mucoperiosteal flaps will be reflected to allow access for implant, distraction osteogenesis, xenograft.
Osteotomy for implant will be carried out with advanced kit of roott_system Switzerland brand, sandwich osteotomy technique will be carried out with three full thickness cuts using the tungsten carbide disc were performed in the form of two vertical cuts away from the neighboring teeth by 3 mm and one horizontal bony cut on the labial surface of alveolar ridge. Bone splitting chisels were used in sequential width (2 mm, 3 mm) and lightweight mallet to complete splitting of the bony segment, the surgical sites will be irrigated with sterile saline. Surgical flaps will be sutured to the pre-surgical level.
Sandwich technique with (RGD), xenograft, collagen membrane and simultaneous implant placement.Biological
All surgery will be in upper arch, for sandwich osteotomy technique, after local anesthesia, crestal incision with buccal intrasulcular incisions will be done extending at least one tooth mesial and distal to the implant associated site. Full thickness mucoperiosteal flaps will be reflected to allow access for implant, distraction osteogenesis, xenograft with and with RGD.
Injectable RGD-bioconjugate Mussel Adhesive Proteins (RGD-MAPs) composite hydroxypropyl methylcellulose (HPMC) hydrogels . Previously we developed a novel type of injectable self-supported hydrogel (2 mg/ml of RGD-MAPs/HPMC) based porcine nano hydroxyapatite (MPH) for dental graft, which could good handling property, biodegradation or biocompatibility with the hydrogel disassembly and provided efficient cell adhesion activity and no inflammatory responses. Surgical flaps will be sutured to the pre-surgical level with 4-0 polyproline non resorbable suture utilizing a single interrupted suturing technique.
| Study group | Role | What they receive |
|---|---|---|
| Sandwich technique with xenograft, collagen membrane and simultaneous implant placement | Placebo comparator | (Control group) will receive computer-guided sandwich osteotomy technique with xenograft, collagen membrane and simultaneous implant placement. Receives: Procedure: Sandwich technique with xenograft, collagen membrane and simultaneous implant placement. |
| Sandwich technique with (RGD), xenograft, collagen membrane and simultaneous implant placement | Active comparator | (Study group) will receive computer-guided sandwich osteotomy technique with (RGD), xenograft, collagen membrane and simultaneous implant placement. Receives: Biological: Sandwich technique with (RGD), xenograft, collagen membrane and simultaneous implant placement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of RGD on volumetric bone changes
Cone beam computed tomography with minimal field of view was taken immediately after surgery, immediately before loading (6 months) and 6 months after loading to evaluate volumetric changes.
Measured: Preoperative Cone beam computed tomography (CBCT) with minimal field of view will be taken for (implant treatment plan), immediately after surgery, at time of loading and 6 months after loading.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start9 May 2024
- Primary completion10 May 2025
- Study completion10 Jun 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 ResorptionStudies 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The patients will be randomly assigned into two groups; Group 1: (Control group) will receive computer-guided sandwich osteotomy technique with xenograft, collagen membrane and simultaneous implant placement. Group 2: (Study group) will receive computer-guided sandwich osteotomy technique with (RGD), xenograft, collagen membrane and simultaneous implant placement.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Khairy morsi, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028606
- Sponsor's protocol ID
- Arginine - Glycine - Aspartic
- Acronym
- RGD
- Status last verified
- Jun 2025
- First submitted
- 17 Apr 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Arginine - Glycine - Aspartic Acid (RGD) Hydrogel on Vertical Ridge Augmentation Using Computer-guided Sandwich Osteotomy Technique, With Xenograft and Simultaneous Implant Placement
- ClinicalTrials.gov ID
- NCT07028606
- Acronym / sponsor ID
- RGD / Arginine - Glycine - Aspartic
- Conditions
- Alveolar Bone Resorption
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 9 May 2024 (actual)
- Primary completion
- 10 May 2025 (actual)
- Study completion
- 10 Jun 2025 (estimated)
- First posted
- 19 Jun 2025 (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.
Researcher will introduce the trial to patients and provide full explanation of its aim and benefits in Arabic language. Patients will then be able to have an informed discussion with the researcher. Researcher will obtain written consent from patients willing to participate in the trial
Detailed description
This protocol and the template informed consent form will be reviewed by the Ethics Committee of Scientific Research -Faculty of Oral and Dental Medicine- Al-Azhar University.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The patients will be randomly assigned into two groups; Group 1: (Control group) will receive computer-guided sandwich osteotomy technique with xenograft, collagen membrane and simultaneous implant placement. Group 2: (Study group) will receive computer-guided sandwich osteotomy technique with (RGD), xenograft, collagen membrane and simultaneous implant placement.
| Arm | Type | Receives |
|---|---|---|
| Sandwich technique with xenograft, collagen membrane and simultaneous implant placement | Placebo comparator | Procedure: Sandwich technique with xenograft, collagen membrane and simultaneous implant placement.(Control group) will receive computer-guided sandwich osteotomy technique with xenograft, collagen membrane and simultaneous implant placement. |
| Sandwich technique with (RGD), xenograft, collagen membrane and simultaneous implant placement | Active comparator | Biological: Sandwich technique with (RGD), xenograft, collagen membrane and simultaneous implant placement.(Study group) will receive computer-guided sandwich osteotomy technique with (RGD), xenograft, collagen membrane and simultaneous implant placement. |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults (age 30-45) with vertical ridge deficiency.
- Patients with maxillary vertical ridge deficiency 4-8mm according to Cologne Classification of Alveolar Ridge Defects (CCARD).
- Patients with good oral hygiene.
- Free from systemic diseases that may influence the outcome of the therapy.
Key exclusion criteria (5 listed)
- Systemic conditions which are generally considered to be a contraindication to implant surgery which included but not limited to: osteoporosis, uncontrolled diabetes.
- Pregnant or lactating females
- Current or former smokers.
- Patient treated by immunosuppressive chemotherapy or radio therapy,
- Allergy to any material or medication used in the study.
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 |
|---|---|---|
| Sandwich technique with xenograft, collagen membrane and simultaneous implant placement.All surgery will be in upper arch, for sandwich osteotomy technique, after local anesthesia, crestal incision with buccal intrasulcular incisions will be done extending at least one tooth mesial and distal to the implant associated site. Full thickness mucoperiosteal flaps will be reflected to allow access for implant, distraction osteogenesis, xenograft. Osteotomy for implant will be carried out with advanced kit of roott_system Switzerland brand, sandwich osteotomy technique will be carried out with three full thickness cuts using the tungsten carbide disc were performed in the form of two vertical cuts away from the neighboring teeth by 3 mm and one horizontal bony cut on the labial surface of alveolar ridge. Bone splitting chisels were used in sequential width (2 mm, 3 mm) and lightweight mallet to complete splitting of the bony segment, the surgical sites will be irrigated with sterile saline. Surgical flaps will be sutured to the pre-surgical level. | Procedure or surgery | Sandwich technique with xenograft, collagen membrane and simultaneous implant placement |
| Sandwich technique with (RGD), xenograft, collagen membrane and simultaneous implant placement.All surgery will be in upper arch, for sandwich osteotomy technique, after local anesthesia, crestal incision with buccal intrasulcular incisions will be done extending at least one tooth mesial and distal to the implant associated site. Full thickness mucoperiosteal flaps will be reflected to allow access for implant, distraction osteogenesis, xenograft with and with RGD. Injectable RGD-bioconjugate Mussel Adhesive Proteins (RGD-MAPs) composite hydroxypropyl methylcellulose (HPMC) hydrogels . Previously we developed a novel type of injectable self-supported hydrogel (2 mg/ml of RGD-MAPs/HPMC) based porcine nano hydroxyapatite (MPH) for dental graft, which could good handling property, biodegradation or biocompatibility with the hydrogel disassembly and provided efficient cell adhesion activity and no inflammatory responses. Surgical flaps will be sutured to the pre-surgical level with 4-0 polyproline non resorbable suture utilizing a single interrupted suturing technique. | Biological | Sandwich technique with (RGD), xenograft, collagen membrane and simultaneous implant placement |
Primary outcome
Effect of RGD on volumetric bone changes
Time frame: Preoperative Cone beam computed tomography (CBCT) with minimal field of view will be taken for (implant treatment plan), immediately after surgery, at time of loading and 6 months after loading.
Cone beam computed tomography with minimal field of view was taken immediately after surgery, immediately before loading (6 months) and 6 months after loading to evaluate volumetric changes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Individual participant dataSharing planned: No
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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.
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 Phase 1 study testing Sandwich technique with xenograft, collagen membrane and simultaneous implant placement. and Sandwich technique with (RGD), xenograft, collagen membrane and simultaneous implant placement. in people with Alveolar Bone Resorption, run by Al-Azhar 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 4 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: under way, not looking for participants, as of the sponsor's last update on 19 Jun 2025. 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. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Effect of RGD on volumetric bone changes (time frame: Preoperative Cone beam computed tomography (CBCT) with minimal field of view will be taken for (implant treatment plan), immediately after surgery, at time of loading and 6 months after loading.). 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 19 Jun 2025.