Implant DentistryNCT06585852
Efficacy of Xenograft Alone or Mixed With Arginyl-Glycyl-Aspartic Acid (RGD) in Horizontal Ridge Augmentation With Split-crest Technique for Implant Placement
A study testing RGD, Xenograft and Split crest technique in people with Implant Dentistry, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The aim of the present study is to evaluate the efficacy of xenograft alone or xenograft mixed with Arginylglycylaspartic acid (RGD) , in horizontal ridge augmentation with split-crest technique, for implant placement. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant Dentistry
- What is being tested?
- RGD, Xenograft and Split crest technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 15 Oct 2024
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults (age 18-30) exhibiting initial insufficiently bone width.
- Patients with good oral hygiene.
- Patients must be free from systemic diseases that may influence the outcome of the therapy.
- Patients with bony horizontal defects alone, Class III \& IV.
Who cannot join
- Heavy smokers.
- Patient treated by immunosuppressive chemotherapy or radio therapy,
- Allergy to any material or medication used in the study.
- Pregnant females.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Al Azhar University of Cairo
Cairo, Nasr City
Mahmoud El Destawy, PHD, +201225864104
Ibrahim Sabri, PHD, +20 100 780 9113
About this study
Official title: Efficacy of Xenograft Alone or Mixed With Arginyl-Glycyl-Aspartic Acid (RGD) in Horizontal Ridge Augmentation With Split-crest Technique for Implant Placement. A Randomized Clinical Trial
The aim of the present study is to evaluate the efficacy of xenograft alone or xenograft mixed with Arginylglycylaspartic acid (RGD) , in horizontal ridge augmentation with split-crest technique, for implant placement.
Read the detailed description
A comparative study for ridge augmentation procedure, With two groups. First group underwent a surgical ridge splitting procedure with ultrasonic bone surgery and grafting with Xenograft alone and implant placement. Second group underwent a surgical ridge splitting procedure with ultrasonic bone surgery Xenograft mix ed with Arginylglycylaspartic acid (RGD) and implant placement.
Both groups were followed up for 1 and 3 months after loading.
- Conditions
- Implant Dentistry
- Being tested
- RGD, Xenograft, Split crest technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RGDDrug
Also called Arginylglycylaspartic acid
Study group main material
XenograftDrug
Scaffold material of choice
Split crest techniqueProcedure or surgery
Piezoelectric surgery
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Xenograft alone with split-crest technique by ultrasonic bone surgery and implant placement. Receives: Drug: Xenograft; Procedure: Split crest technique |
| Study Group | Experimental | Xenograft mixed with RGD with split-crest technique by ultrasonic bone surgery and implant placement. Receives: Drug: RGD; Drug: Xenograft; Procedure: Split crest technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
ISQ measurement for implant stability
Evaluate implant stability by osstell device
Measured: At time of surgery, at loading and 3 months after loading.
Secondary outcomes (1)
Bone density around dental implants.
Evaluation of bone density after ridge splitting and implant placement
Measured: At time of loading and 3 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 Sep 2024
- Study start1 Aug 2023
- Primary completion1 Sep 2024
- Study completion15 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant DentistryStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, muhammed nagy, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585852
- Sponsor's protocol ID
- RGD in Ridge splitting
- Status last verified
- Sep 2024
- First submitted
- 1 Sep 2024
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Xenograft Alone or Mixed With Arginyl-Glycyl-Aspartic Acid (RGD) in Horizontal Ridge Augmentation With Split-crest Technique for Implant Placement. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06585852
- Acronym / sponsor ID
- RGD in Ridge splitting
- Conditions
- Implant Dentistry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 15 Oct 2024 (estimated)
- First posted
- 19 Sep 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 present study is to evaluate the efficacy of xenograft alone or xenograft mixed with Arginylglycylaspartic acid (RGD) , in horizontal ridge augmentation with split-crest technique, for implant placement.
Detailed description
A comparative study for ridge augmentation procedure, With two groups. First group underwent a surgical ridge splitting procedure with ultrasonic bone surgery and grafting with Xenograft alone and implant placement. Second group underwent a surgical ridge splitting procedure with ultrasonic bone surgery Xenograft mix ed with Arginylglycylaspartic acid (RGD) and implant placement.
Both groups were followed up for 1 and 3 months after loading.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Drug: Xenograft, Procedure: Split crest techniqueXenograft alone with split-crest technique by ultrasonic bone surgery and implant placement. |
| Study Group | Experimental | Drug: RGD, Drug: Xenograft, Procedure: Split crest techniqueXenograft mixed with RGD with split-crest technique by ultrasonic bone surgery and implant placement. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults (age 18-30) exhibiting initial insufficiently bone width.
- Patients with good oral hygiene.
- Patients must be free from systemic diseases that may influence the outcome of the therapy.
- Patients with bony horizontal defects alone, Class III \& IV.
Key exclusion criteria (4 listed)
- Heavy smokers.
- Patient treated by immunosuppressive chemotherapy or radio therapy,
- Allergy to any material or medication used in the study.
- Pregnant females.
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 |
|---|---|---|
| RGDAlso: Arginylglycylaspartic acidStudy group main material | Drug | Study Group |
| XenograftScaffold material of choice | Drug | Control Group, Study Group |
| Split crest techniquePiezoelectric surgery | Procedure or surgery | Control Group, Study Group |
Primary outcome
ISQ measurement for implant stability
Time frame: At time of surgery, at loading and 3 months after loading.
Evaluate implant stability by osstell device
1 secondary outcome
Bone density around dental implants.
Time frame: At time of loading and 3 months after loading
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Related trials for Implant Dentistry
Recruiting
Evaluation of Different Grafting Technique of Thin Gingival Phenotype With Delayed Dental Implants
Implant Dentistry, Connective Tissue Graft
Recruiting
Home-Use Dual-Light Antibacterial Photodynamic Therapy for Peri-Implant Mucositis in Full-Arch Implant Prostheses
Peri Implant Mucositis, Dental Implant Rehabilitation
Enrolling by invitationObservational study
The General Aim is to Implement Clinical Assessment of Overload by Voluntary Bite Force Registration to Enable Future Simple But Precise Risk Assessment to Provide Individualized Treatment Plans.
Dental Implant, Bruxism
RecruitingObservational study
Assessing Current Clinical Concepts in Dental Practice
Dental Implant
Recruiting
Accuracy of the Calibrated Framework for Intra Oral Full Arch Scan (A Cross-over Study)
Edentulism, Dental Implants
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RGD, Xenograft and Split crest technique in people with Implant Dentistry, 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 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 19 Sep 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 Mahmoud Taha, PHD (01225864104, info@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ISQ measurement for implant stability (time frame: At time of surgery, at loading and 3 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 Sep 2024.