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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06388837
Other study ID # RECO6U/20- 2021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 20, 2021
Est. completion date March 1, 2023

Study information

Verified date April 2024
Source October 6 University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date March 1, 2023
Est. primary completion date March 1, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 40 Years
Eligibility 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: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Injectable Platelet Rich Fibrin
Patients underwent mandibular symphysis Onlay bone graft mixed with injectable platelet rich fibrin (I-PRF) placement.
Xenograft
Patients underwent mandibular symphysis Onlay bone graft mixed with Xenograft (InterOss® Anorganic Cancellous Granules).

Locations

Country Name City State
Egypt October 6 University Giza

Sponsors (1)

Lead Sponsor Collaborator
October 6 University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 months postoperative
Secondary 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. 6 months postoperative