Repeated Injection of I PRF and Autogenous Bone Graft for Alveolar Ridge Augmentation (I-PRF)

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:

Study Overview

• Status: Completed
• Conditions: Alveolar Bone Loss; Alveolar Ridge Abnormality
• Intervention / Treatment: Procedure: khoury technique; Procedure: khoury technique with i-PRF injections

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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Heliopolis - Cairo
    • Cairo, Heliopolis - Cairo, Egypt, 123456
      • Faculty of Dentistry , Al Azhar Univeristy For Girls

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• patients who have a horizontal or vertical alveolar ridge deficiency

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control; bone grafting	Procedure: khoury technique; autogenous bone augmentation
Active Comparator: study; bone grafting & i PRF	Procedure: khoury technique with i-PRF injections; autogenous bone augmentation with repeated i-PRF injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
width of the alveolar ridge	CBCT will be used to assess the width of the alveolar ridge	baseline, 6 months & 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
volumetric analysis of bone	volumetric analysis ob bone using CBCT to assess the bone volume	at baseline, 6 and 9 months

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Zainab H Abdel Rahman, Phd

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): November 1, 2024

Study Registration Dates

• First Submitted: November 22, 2024
• First Submitted That Met QC Criteria: November 28, 2024
• First Posted (Estimated): December 2, 2024

Study Record Updates

• Last Update Posted (Estimated): December 2, 2024
• Last Update Submitted That Met QC Criteria: November 28, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: A lveolar ridge defect , Khoury technique Guided bone regeneration, i PRF, CBCT analysis
• Additional Relevant MeSH Terms: Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Alveolar Bone Loss
• Other Study ID Numbers: alveolar ridge augmenation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No