Ridge Splitting With Simultaneous Implant Placement Using i-PRF

NCT05010785 | Completed

• 1 other identifier: KFSIRB200-73
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ridge Splitting; i-PRF; Dental Implant

Outcome Measures

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.

  9 months

Study Arms (2)

alveolar ridge splitting with GBR and i-PRF

EXPERIMENTAL

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

alveolar ridge splitting with GBR

ACTIVE COMPARATOR

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

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

alveolar ridge splitting with GBR and 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

alveolar ridge splitting with GBR

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Faculty of Dentistry, Kafrelsheikh University

Kafr ash Shaykh, 33511, Egypt

Location

MeSH Terms

Interventions

proliferation regulatory factors, human urine

Study Officials

• Dalia R Issa, PhD

  Kafrelsheikh University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: August 1, 2021
• First Posted: August 18, 2021
• Study Start: August 20, 2021
• Primary Completion: November 3, 2022
• Study Completion: November 15, 2022
• Last Updated: December 22, 2023

Record last verified: 2023-12

Locations

EG (1)