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CompletedNCT06388837Updated Apr 29, 2024

Effect of Symphysis Onlay Bone Graft, Injectable Platelet Rich Fibrin (I-PRF) and Xenograft on Horizontal Alveolar Ridge Augmentation in Esthetic Zone

An interventional study of Injectable Platelet Rich Fibrin and Xenograft in Symphysis Onlay Bone Graft, Platelet Rich Fibrin and Xenograft, sponsored by October 6 University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-04-29.

Sponsored by October 6 University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 3 years 2 months after the study started (first participant enrolled Feb 2021, registered Apr 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
All
01

Study summary

The aim of the study: was to evaluate whether mandibular symphysis Onlay autogenous bone graft mixed with Injectable PRF could offer any advantages for patients undergoing horizontal alveolar ridge widening regarding increase alveolar ridge width compared to mandibular symphysis Onlay autogenous bone graft mixed with Xenograft

Read the detailed description

Alveolar bone resorption is one of complications post-extraction complications where there is a reduction in the dimensions and quality of the alveolar bone. Alveolar bone resorption is known to occur over time, but resorption in the first few months of tooth extraction is known to be very significant.

The ideal bone graft material should have osteoconductive, osteogenic, and osteoinductive properties and mechanical stability and be free from disease. Osteoconductive is a physical property of a material that provides a framework for the growth of blood vessels and osteoprogenitor cells in bone formation. Osteoinductiveness is the ability to stimulate stem cells to differentiate in mature cells through stimulation by local growth factors. Osteogenicity is the bone growth factors in bone grafts.

Growth factors from PRF such as platelet-derived growth factor (PDGF), transforming growth factor (TGF), and insulin growth factor (IGF) are known to play a significant role in healing and bone regeneration to prevent excessive alveolar resorption after tooth extraction.

02

Conditions studied

  • Symphysis Onlay Bone Graft
  • Platelet Rich Fibrin
  • Xenograft
  • Horizontal Alveolar Ridge Augmentation
  • Esthetic Zone
03

In context

Lead sponsor

October 6 University is the lead sponsor of 142 studies on the registry; 28 are open to participants now.

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

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age from 20 to 40 years.
  • Both sexes.
  • Patients suffering from horizontal alveolar ridge deficiency in anterior maxilla with labio-palatal dimensions less than 4 mm.
  • Patients with adequate vertical ridge height compared to the neighboring alveolar bone.
  • Patients with good oral hygiene and adjacent teeth bounding the empty span (span ranged from 1 to 4 missing teeth), should have healthy periodontium, intact or properly restored.
  • Patients were apparently free from any systemic disease that may affect normal healing process of bone.

Exclusion criteria

Exclusion Criteria:

  • Patients suffering from any systemic diseases were excluded from the study.
  • Poor oral hygiene and motivation.
  • General contraindications to implant surgery.
  • Uncontrolled diabetes.
  • Irradiation, chemotherapy, or immunosuppressive therapy over the past 5 years.
  • Active periodontitis.
  • Psychiatric problems.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Group I (Symphysis Onlay bone graft with injectable platelet rich fibrin placement)

    Patients underwent mandibular symphysis Onlay bone graft mixed with injectable platelet rich fibrin (I-PRF) placement.

    Other: Injectable Platelet Rich Fibrin

  • Experimental
    Group II (Symphysis Onlay bone graft mixed with Xenograft)

    Patients underwent mandibular symphysis Onlay bone graft mixed with Xenograft (InterOss® Anorganic Cancellous Granules).

    Other: Xenograft

Interventions

  • OtherInjectable Platelet Rich Fibrin

    Patients underwent mandibular symphysis Onlay bone graft mixed with injectable platelet rich fibrin (I-PRF) placement.

  • OtherXenograft

    Patients underwent mandibular symphysis Onlay bone graft mixed with Xenograft (InterOss® Anorganic Cancellous Granules).

06

What researchers measure

Primary outcomes

  1. Alveolar ridge width

    Cone beam computed tomography (CBCT) was done to all patients to measure alveolar ridge width at the following intervals: pre-operative and 6 months postoperative.

    Time frame: 6 months postoperative

Secondary outcomes

  1. Bone density

    Cone beam computed tomography (CBCT) was done to all patients to measure bone density at the following intervals: pre-operative and 6 months postoperative.

    Time frame: 6 months postoperative

07

Study locations

1 site
  • October 6 University
    Giza, 12511, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Supporting information: Study protocol

Time frame: After the end of study for one year.

Access criteria: The data will be available upon a reasonable request from the corresponding author.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06388837
Responsible party
Amany Ahmed Mohamed Alaraby (Lecturer of Oral Medicine, Diagnosis and Periodontology Department, Faculty of Dentistry, October 6 University, 6 October city, Egypt, October 6 University) — Principal investigator
First posted
Apr 29, 2024
Start date
Feb 20, 2021
Primary completion
Mar 1, 2023
Completion
Mar 1, 2023
Last update
Apr 29, 2024

Oversight

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

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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