Scheduled Autologous PRP Guided Injection in the Maxillary Bony Defects

NCT07108933 | Completed Phase 2 DMC

• 1 other identifier: PRP in maxillary bone defects
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Scheduled autologous platelet-rich plasma guided injection is done in critical-sized maxillary bony defects after surgical excision of non- malignant lesions.

Conditions

Bony Defect

Keywords

Platelet-rich plasma, scheduled injection, healing process

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Bone density at the injected site

  after 3 months

Study Arms (1)

Injection

OTHER

Scheduled injection of autologous platelet-rich plasma

Biological: Autologous platelet-rich plasma

Interventions

Autologous platelet-rich plasma BIOLOGICAL

Guided injection of PRP in bony cavities of maxilla after surgical excision of non-malignant tumors.

Also known as: PRP

Injection

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Horus University: lead

Study Sites (1)

Dental clinics of Aswan University Hospital

Aswān, Egypt

Location

Study Officials

• Eman Abdel Salam, Prof

  Head of department of Oral Surgery

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Randomized Clinical Trial (RCT)

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 7, 2025
• Study Start: August 15, 2023
• Primary Completion: October 15, 2024
• Study Completion: April 15, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-07

Locations

EG (1)