Scheduled Autologous PRP Guided Injection in the Maxillar... | NCT07108933

Studies
Scheduled Autologous PRP Guided Injection in the Maxillary Bony Defects

NCT07108933

Sponsor

Horus University

Status

Completed

Last Update Posted

Aug 7, 2025Actual

Enrollment

16Actual

Phase

Phase 2

Conditions

Bony Defect

Interventions

Autologous platelet-rich plasma

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 15, 2023Actual

Primary Completion Date

Oct 15, 2024Actual

Completion Date

Apr 15, 2025Actual

First Submitted Date

Jul 31, 2025

First Submission Date that Met QC Criteria

Jul 31, 2025

First Posted Date

Aug 7, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2025

Last Update Posted Date

Aug 7, 2025Actual

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Injection	Other	Scheduled injection of autologous platelet-rich plasma	Biological: Autologous platelet-rich plasma

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Autologous platelet-rich plasma	Biological	Guided injection of PRP in bony cavities of maxilla after surgical excision of non-malignant tumors.	Injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Volume of the injected bony defect	the volume of the injected bony defect is measured by Cone beam computed tomography in millimeters cubic.	after 3 months

Secondary Outcomes

Measure	Description	Time Frame
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.	after 3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided