Alveolar Bone LossI-PRFNCT06711250
Repeated Injection of I PRF and Autogenous Bone Graft for Alveolar Ridge Augmentation
A study testing khoury technique and khoury technique with i-PRF injections in people with Alveolar Bone Loss and Alveolar Ridge Abnormality, run by Ain Shams University at 1 site in Egypt.
Trial summary
The current st udy's objective was to validate the repeated effect of i PRF with autogenous bone on the of gingival thickness , width a n d volumetric bone changes durig maxillary alveolar augmentation using cone beam computer tomography (CBCT). Patients and methods: Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss, Alveolar Ridge Abnormality
- What is being tested?
- khoury technique and khoury technique with i-PRF injections
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 1 Nov 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients who have a horizontal or vertical alveolar ridge deficiency
Who cannot join
- patients showing any signs of active periodontal disease
- patients on long term corticosteroid therapy,
- patients taking bone metabolism drugs
- patients suffering from any systemic illness that may impact bone repair
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry , Al Azhar Univeristy For Girls
Cairo, Heliopolis - Cairo, 123456
About this study
Official title: Repeated Injection of I PRF and Autogenous Bone Graft for Alveolar Ridge Augmentation :randomized Controlled Clinical Trial
The current st udy's objective was to validate the repeated effect of i PRF with autogenous bone on the of gingival thickness , width a n d volumetric bone changes durig maxillary alveolar augmentation using cone beam computer tomography (CBCT). Patients and methods:
Read the detailed description
The study was a randomized clinical study in which participants needed to augment defective ridge were selected from the Outpatient Clinic, Department of Oral Medicine, Periodontology and Diagnosis , Faculty of Dental Medicine for Girls, Al Azhar University. The Research Ethics Committee, Faculty of Dental Medicine for Girls, Al Azhar University (REC code (P. PD 24 19 ) certified this study and a signed informed consent form with approval was obtained from each. Each patient who was enrolled in the study had a complete medical record and a proper clinical examination. These patients had to have a horizontal or vertical alveolar ridge deficiency and have enough bone in the mandibular donor site (external oblique ridge).
However, patients showing any signs of active periodontal disease, on long term corticosteroid therapy, persons taking bone metabolism drugs as well as individuals suffering from any systemic illness that may impact bone repair were excluded from the study.
Patients were assigned to one of two 2 groups, group I or group II. Group I, consisted of patients grafted with autogenous bone graft alone. I n Group II, patients were grafted using autogenous bone combined with repeated injection of i PRF Assessment of the alveolar ridge dimension and the bone block to be harvested preoperatively using CBCT. T he measurements of the alveolar ridge mesio distaly and bucco lingually in mm were determined at the recipient site . It was crucial to visualize the anatomic structures at the osteotomy site, including the alveolar canal, the mental foramina, and the teeth roots present to create ideal bone cutting planes according to the depth and extension of the graft without any injuries to the aforementioned structures.
- Conditions
- Alveolar Bone Loss, Alveolar Ridge Abnormality
- Being tested
- khoury technique, khoury technique with i-PRF injections
- Keywords
- A lveolar ridge defect , Khoury technique Guided bone regeneration, i PRF, CBCT analysis
- 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.
khoury techniqueProcedure or surgery
autogenous bone augmentation
khoury technique with i-PRF injectionsProcedure or surgery
autogenous bone augmentation with repeated i-PRF injections
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | bone grafting Receives: Procedure: khoury technique |
| study | Active comparator | bone grafting \& i PRF Receives: Procedure: khoury technique with i-PRF injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
width of the alveolar ridge
CBCT will be used to assess the width of the alveolar ridge
Measured: baseline, 6 months & 9 months
Secondary outcomes (1)
volumetric analysis of bone
volumetric analysis ob bone using CBCT to assess the bone volume
Measured: at baseline, 6 and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start1 Apr 2024
- Primary completion1 Sep 2024
- Study completion1 Nov 2024
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.
- More trials run by Ain Shams 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zainab H Abdel Rahman, Phd, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711250
- Sponsor's protocol ID
- alveolar ridge augmenation
- Acronym
- I-PRF
- Status last verified
- Nov 2024
- First submitted
- 22 Nov 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated Injection of I PRF and Autogenous Bone Graft for Alveolar Ridge Augmentation :randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06711250
- Acronym / sponsor ID
- I-PRF / alveolar ridge augmenation
- Conditions
- Alveolar Bone Loss, Alveolar Ridge Abnormality
- Keywords
- A lveolar ridge defect , Khoury technique Guided bone regeneration, i PRF, CBCT analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 2 Dec 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 current st udy's objective was to validate the repeated effect of i PRF with autogenous bone on the of gingival thickness , width a n d volumetric bone changes durig maxillary alveolar augmentation using cone beam computer tomography (CBCT). Patients and methods:
Detailed description
The study was a randomized clinical study in which participants needed to augment defective ridge were selected from the Outpatient Clinic, Department of Oral Medicine, Periodontology and Diagnosis , Faculty of Dental Medicine for Girls, Al Azhar University. The Research Ethics Committee, Faculty of Dental Medicine for Girls, Al Azhar University (REC code (P. PD 24 19 ) certified this study and a signed informed consent form with approval was obtained from each. Each patient who was enrolled in the study had a complete medical record and a proper clinical examination. These patients had to have a horizontal or vertical alveolar ridge deficiency and have enough bone in the mandibular donor site (external oblique ridge).
However, patients showing any signs of active periodontal disease, on long term corticosteroid therapy, persons taking bone metabolism drugs as well as individuals suffering from any systemic illness that may impact bone repair were excluded from the study.
Patients were assigned to one of two 2 groups, group I or group II. Group I, consisted of patients grafted with autogenous bone graft alone. I n Group II, patients were grafted using autogenous bone combined with repeated injection of i PRF Assessment of the alveolar ridge dimension and the bone block to be harvested preoperatively using CBCT. T he measurements of the alveolar ridge mesio distaly and bucco lingually in mm were determined at the recipient site . It was crucial to visualize the anatomic structures at the osteotomy site, including the alveolar canal, the mental foramina, and the teeth roots present to create ideal bone cutting planes according to the depth and extension of the graft without any injuries to the aforementioned structures.
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 | Active comparator | Procedure: khoury techniquebone grafting |
| study | Active comparator | Procedure: khoury technique with i-PRF injectionsbone grafting \& i PRF |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients who have a horizontal or vertical alveolar ridge deficiency
Key exclusion criteria (4 listed)
- patients showing any signs of active periodontal disease
- patients on long term corticosteroid therapy,
- patients taking bone metabolism drugs
- patients suffering from any systemic illness that may impact bone repair
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 |
|---|---|---|
| khoury techniqueautogenous bone augmentation | Procedure or surgery | control |
| khoury technique with i-PRF injectionsautogenous bone augmentation with repeated i-PRF injections | Procedure or surgery | study |
Primary outcome
width of the alveolar ridge
Time frame: baseline, 6 months & 9 months
CBCT will be used to assess the width of the alveolar ridge
1 secondary outcome
volumetric analysis of bone
Time frame: at baseline, 6 and 9 months
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 2 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Alveolar Bone Loss
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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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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.
Zainab H Abdel Rahman, Phd principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing khoury technique and khoury technique with i-PRF injections in people with Alveolar Bone Loss and Alveolar Ridge Abnormality, run by Ain Shams 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 1 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: finished, as of the sponsor's last update on 2 Dec 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?
width of the alveolar ridge (time frame: baseline, 6 months & 9 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 2 Dec 2024.