- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04744012
Modified Periostal Pocket Flap Technique
Modified Periostal Pocket Flap Technique: a Case Series
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
unique group
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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Volume of bone augmentation
Time Frame: 4 months
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jesús Torres, Associate, Universidad Complutense de Madrid
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- P-15/568
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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