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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04744012
Other study ID # P-15/568
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 11, 2016
Est. completion date October 1, 2019

Study information

Verified date May 2022
Source Universidad Complutense de Madrid
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to propose a modification of the original periostal pocket flap technique consisting in replacing the xenograft by a conglomerate which contains autologous bone obtained from the future implant site through biological drilling technique and PRGF (Plasma Rich in Growth Factors)


Description:

Materials and methods: 8 patients referred for implant placement and with a slight bucco-lingual (BL) width deficiency in alveolar bone were included in the study. Patients were placed dental implants and bone width was augmented by using the conglomerate mentioned above.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date October 1, 2019
Est. primary completion date September 24, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with a favorable bone density and favorable bone length but insufficient bone width that could compromise implant placement Exclusion Criteria: - Smokers (>10 cigarettes per day) and patients with severe systemic disease ( ASA III or IV - American Society of Anaesthesiology)

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Modified Periostal Pocket Flap Technique
After local anesthesia, a full thickness flap was elevated from the lingual wall and a partial thickness flap was performed in the buccal one. After that, the buccal periosteum was detached and dental implants were placed following the biological drilling protocol, getting autologous bone particles from the implant site. Patient's blood collection was performed and the plasm obtained was poured down on a sterile container and mixed with autologous bone particles collected previously during the drilling procedure. Finally the graft was placed in the pocket prepared previously and the surgical wound was sutured in two planes.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universidad Complutense de Madrid

Outcome

Type Measure Description Time frame Safety issue
Primary Volume of bone augmentation Volume of bone augmentation of the surgical sites was measured in the postoperative parasagittal CT scans using a region of interest (ROI) containing the entire bone box regenerated area using the closed polygon tool of the OsiriX software 4 months
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