Ridge Splitting With Simultaneous Implant Placement Using i-PRF

Ridge Splitting With Simultaneous Implant Placement Using i-PRF With Guided Bone Regeneration: a Randomized Clinical Trial

Sohn introduced the concept of sticky bone in which i-PRF is mixed with the granules of bone graft, leading to fabrication of growth factors-enriched bone graft matrix using autologous fibrin glue. This minimizes bone loss and accelerates tissue healing during healing period. The present study was conducted to evaluate the clinical and radiographic outcomes following the application of the alveolar ridge splitting in combination with the use of guided bone regeneration (GBR) with or without i-PRF (sticky bone), associated with immediate implant placement in patients with horizontally atrophic jaw bones.

Study Overview

• Status: Completed
• Conditions: Dental Implant; Ridge Splitting; i-PRF
• Intervention / Treatment: Procedure: Immediate implant placement and alveolar ridge splitting with GBR and i-PRF; Procedure: Immediate implant placement and alveolar ridge splitting with GBR

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Kafr Ash Shaykh, Egypt, 33511
    • faculty of dentistry, kafrelsheikh University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• good general health at the time of surgery.
• at least 3 months of healing after tooth extraction.
• horizontally compromised alveolar ridges at least 10 mm high and 3 mm wide.

Exclusion Criteria:

• a vertical bone defect in the edentulous ridge.
• thick cortex in the labial/buccal with less cancellous bone inside
• obvious undercut on the labial/buccal side.
• uncontrolled periodontal conditions or other oral disorders.
• history of radiotherapy in the head and neck region.
• uncontrolled diabetes mellitus or other systematic disorders.
• smokers.
• Pregnancy.
• non-compliant patients.
• allergic reaction to the medications used

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
Experimental: alveolar ridge splitting with GBR and i-PRF; alveolar ridge splitting in combination with the use of GBR with i-PRF (sticky bone) with immediate implant placement	Procedure: Immediate implant placement and alveolar ridge splitting with GBR and i-PRF; Implant insertion and GBR for augmentation of the gap between buccal and lingual plate using bone graft mixed with i-PRF
Active Comparator: alveolar ridge splitting with GBR; alveolar ridge splitting in combination with the use of GBR without i-PRF (sticky bone) with immediate implant placement	Procedure: Immediate implant placement and alveolar ridge splitting with GBR; Implant insertion and GBR for augmentation of the gap between buccal and lingual plate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurements of the amount of bone formation in millimeters around immediately placed dental implants	Measurements of the amount of bone formation in millimeters using GBR with or without the combined effect of i-PRF in the ridge splitting following immediate implant placement.	9 months

Collaborators and Investigators

• Sponsor: Kafrelsheikh University
• Investigators: Principal Investigator: Dalia R Issa, PhD, Kafrelsheikh University

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2021
• Primary Completion (Actual): November 3, 2022
• Study Completion (Actual): November 15, 2022

Study Registration Dates

• First Submitted: August 1, 2021
• First Submitted That Met QC Criteria: August 15, 2021
• First Posted (Actual): August 18, 2021

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: KFSIRB200-73

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No