Ridge Splitting With Simultaneous Implant Placement Using i-PRF

Sponsor

Kafrelsheikh University (Other)

Overall Status

Completed

CT.gov ID

NCT05010785

Collaborator

(none)

Enrollment

Location

Arms

18.4

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ridge Splitting i-PRF Dental Implant	Procedure: Immediate implant placement and alveolar ridge splitting with GBR and i-PRF Procedure: Immediate implant placement and alveolar ridge splitting with GBR	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 4, 2020

Actual Primary Completion Date :

Nov 3, 2021

Actual Study Completion Date :

Nov 15, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry, Kafrelsheikh University	Kafr Ash Shaykh		Egypt	33511

Sponsors and Collaborators

Kafrelsheikh University

Investigators

Principal Investigator: Dalia R Issa, PhD, Kafrelsheikh University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dalia Rasheed Issa, principal investigator, Kafrelsheikh University

ClinicalTrials.gov Identifier:

NCT05010785

Other Study ID Numbers:

KD/21/20

First Posted:

Aug 18, 2021

Last Update Posted:

Apr 4, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 4, 2022