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Ridge Splitting With Simultaneous Implant Placement Using i-PRF

NCT ID: NCT05010785

Last Updated: 2023-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-20

Study Completion Date

2022-11-15

Brief Summary

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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.

Detailed Description

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Conditions

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Ridge Splitting i-PRF Dental Implant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

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

Intervention Type 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

alveolar ridge splitting in combination with the use of GBR without i-PRF (sticky bone) with immediate implant placement

Group Type ACTIVE_COMPARATOR

Immediate implant placement and alveolar ridge splitting with GBR

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Immediate implant placement and alveolar ridge splitting with GBR

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kafrelsheikh University

OTHER

Sponsor Role lead

Responsible Party

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Dalia Rasheed Issa

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dalia R Issa, PhD

Role: PRINCIPAL_INVESTIGATOR

Kafrelsheikh University

Locations

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Faculty of Dentistry, Kafrelsheikh University

Kafr ash Shaykh, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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KFSIRB200-73

Identifier Type: -

Identifier Source: org_study_id