Ridge Splitting With Simultaneous Implant Placement Using i-PRF

Dental Implant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05010785
• Other study ID #: KFSIRB200-73
• Status: Completed
• Phase: N/A
• Start date: August 20, 2021
• Est. completion date: November 15, 2022

Study information

• Verified date: December 2023
• Source: Kafrelsheikh University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 15, 2022
• Est. primary completion date: November 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Implant
• Ridge Splitting

Intervention

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
• Immediate implant placement and alveolar ridge splitting with GBR
Implant insertion and GBR for augmentation of the gap between buccal and lingual plate

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Kafrelsheikh University	Kafr Ash Shaykh

Sponsors (1)

Lead Sponsor	Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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