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Completed

NCT Number: NCT05010785

Ridge Splitting With Simultaneous Implant Placement Using i-PRF

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.

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Key information

Conditions

Ridge Splitting Dental Implant i-PRF

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Kafrelsheikh University

Kafr ash Shaykh, 33511, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immediate implant placement and alveolar ridge splitting with GBR and i-PRF

Procedure

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

Procedure

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

Primary outcomes

  1. Measurements of the amount of bone formation in millimeters around immediately placed dental implants

    Time frame: 9 months

    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.

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 18, 2021
Registry last updated
Dec 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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