Bony DefectPhase 2NCT07108933
Scheduled Autologous PRP Guided Injection in the Maxillary Bony Defects
A Phase 2 study testing Autologous platelet-rich plasma in people with Bony Defect, run by Horus University at 1 site in Egypt.
Trial summary
Scheduled autologous platelet-rich plasma guided injection is done in critical-sized maxillary bony defects after surgical excision of non- malignant lesions. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Bony Defect
- What is being tested?
- Autologous platelet-rich plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2023to 15 Apr 2025
- Phase
- Phase 2
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18-65 years (adults within a specific age range).
- Diagnosis: Non-malignant maxillary bony defects (e.g., benign tumors or cysts).
- Health: Generally healthy participants who can tolerate surgery.
- Platelet Function: No platelet disorders or blood-related conditions.
- Willingness: Informed consent and ability to follow the protocol.
- No Use of Blood Thinners: No current use of anticoagulants like aspirin.
Who cannot join
- Age: Children (under 18) and elderly (over 75).
- Malignant Lesions: Participants with cancer or pre-cancerous conditions.
- Systemic Illness: Severe conditions (e.g., uncontrolled diabetes, autoimmune disorders).
- Platelet Disorders: Low platelet count or bleeding disorders (e.g., hemophilia).
- Infections: Active infections or inflammatory conditions (e.g., periodontal disease).
- Pregnancy: Women who are pregnant or breastfeeding.
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- Recent Surgery/Trauma: Recent maxillary surgery or trauma.
- Uncontrolled Medications: Use of blood thinners, NSAIDs, or immunosuppressive drugs.
- Non-compliance: Unwillingness or inability to follow-up with the protocol.
- Substance Abuse: Active drug or alcohol abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Scheduled Autologous Platelet-rich Plasma Guided Injection in the Healing Process of Critical-sized Maxillary Bony Defects After Surgical Excision of Non- Malignant Lesions: A Prospective Randomized Clinical Trial.
Scheduled autologous platelet-rich plasma guided injection is done in critical-sized maxillary bony defects after surgical excision of non- malignant lesions.
Read the detailed description
The study aims to detect the effect of scheduled autologous platelet-rich plasma- guided injection in the healing process of critical-sized maxillary bony defects after surgical removal of non-malignant lesions by using bone volumetric analysis and density measuring with cone beam computed tomography.
- Conditions
- Bony Defect
- Being tested
- Autologous platelet-rich plasma
- Keywords
- Platelet-rich plasma, scheduled injection, healing process
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous platelet-rich plasmaBiological
Also called PRP
Guided injection of PRP in bony cavities of maxilla after surgical excision of non-malignant tumors.
| Study group | Role | What they receive |
|---|---|---|
| Injection | Other | Scheduled injection of autologous platelet-rich plasma Receives: Biological: Autologous platelet-rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of the injected bony defect
the volume of the injected bony defect is measured by Cone beam computed tomography in millimeters cubic.
Measured: after 3 months
Secondary outcomes (1)
Bone density at the injected site
the density of bone formed at the injected site is measured by Cone beam computed tomography in Hounsfield unit.
Measured: after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start15 Aug 2023
- Primary completion15 Oct 2024
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bony DefectStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Randomized Clinical Trial (RCT)
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Abdel Salam Yousef, Horus University
- Investigators
- Eman Abdel Salam, Prof, Study director, Head of department of Oral Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108933
- Sponsor's protocol ID
- PRP in maxillary bone defects
- Status last verified
- Jul 2025
- First submitted
- 31 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Scheduled Autologous Platelet-rich Plasma Guided Injection in the Healing Process of Critical-sized Maxillary Bony Defects After Surgical Excision of Non- Malignant Lesions: A Prospective Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07108933
- Acronym / sponsor ID
- PRP in maxillary bone defects
- Conditions
- Bony Defect
- Keywords
- Platelet-rich plasma, scheduled injection, healing process
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Horus UniversityUniversity, hospital or other
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 7 Aug 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.
Scheduled autologous platelet-rich plasma guided injection is done in critical-sized maxillary bony defects after surgical excision of non- malignant lesions.
Detailed description
The study aims to detect the effect of scheduled autologous platelet-rich plasma- guided injection in the healing process of critical-sized maxillary bony defects after surgical removal of non-malignant lesions by using bone volumetric analysis and density measuring with cone beam computed tomography.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Randomized Clinical Trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| Injection | Other | Biological: Autologous platelet-rich plasmaScheduled injection of autologous platelet-rich plasma |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age: 18-65 years (adults within a specific age range).
- Diagnosis: Non-malignant maxillary bony defects (e.g., benign tumors or cysts).
- Health: Generally healthy participants who can tolerate surgery.
- Platelet Function: No platelet disorders or blood-related conditions.
- Willingness: Informed consent and ability to follow the protocol.
Key exclusion criteria (10 listed)
- Age: Children (under 18) and elderly (over 75).
- Malignant Lesions: Participants with cancer or pre-cancerous conditions.
- Systemic Illness: Severe conditions (e.g., uncontrolled diabetes, autoimmune disorders).
- Platelet Disorders: Low platelet count or bleeding disorders (e.g., hemophilia).
- Infections: Active infections or inflammatory conditions (e.g., periodontal disease).
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 |
|---|---|---|
| Autologous platelet-rich plasmaAlso: PRPGuided injection of PRP in bony cavities of maxilla after surgical excision of non-malignant tumors. | Biological | Injection |
Primary outcome
Volume of the injected bony defect
Time frame: after 3 months
the volume of the injected bony defect is measured by Cone beam computed tomography in millimeters cubic.
1 secondary outcome
Bone density at the injected site
Time frame: after 3 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 7 Aug 2025.
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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.
Eman Abdel Salam, Prof study director
Head of department of Oral Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Autologous platelet-rich plasma in people with Bony Defect, run by Horus 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 6 inclusion and 10 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 7 Aug 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Volume of the injected bony defect (time frame: after 3 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 Aug 2025.