CClinicalTrials.gg
CompletedNCT05010785Updated Dec 22, 2023

Ridge Splitting With Simultaneous Implant Placement Using i-PRF

An interventional study of Immediate implant placement and alveolar ridge splitting with GBR and i-PRF and Immediate implant placement and alveolar ridge splitting with GBR in Ridge Splitting, i-PRF and Dental Implant, sponsored by Kafrelsheikh University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-22.

Sponsored by Kafrelsheikh University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Ridge Splitting
  • i-PRF
  • Dental Implant
03

In context

Lead sponsor

Kafrelsheikh University is the lead sponsor of 285 studies on the registry; 110 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
22 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • ProcedureImmediate 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

  • ProcedureImmediate implant placement and alveolar ridge splitting with GBR

    Implant insertion and GBR for augmentation of the gap between buccal and lingual plate

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 9 months

07

Study locations

1 site
  • Faculty of Dentistry, Kafrelsheikh University
    Kafr Ash Shaykh, 33511, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05010785
Lead sponsor
Kafrelsheikh University
Responsible party
Dalia Rasheed Issa (principal investigator, Kafrelsheikh University) — Principal investigator
First posted
Aug 18, 2021
Start date
Aug 20, 2021
Primary completion
Nov 3, 2022
Completion
Nov 15, 2022
Last update
Dec 22, 2023

Study contacts

Dalia R Issa, PhD
principal investigator · Kafrelsheikh University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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