NCT04744012

Brief 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)

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 11, 2016

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2016

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 8, 2021

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

13 days

First QC Date

February 3, 2021

Last Update Submit

May 17, 2022

Conditions

Keywords

Periostal Pocket Flap TechniquePPFT

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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.

Procedure: Modified Periostal Pocket Flap Technique

Interventions

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.

unique group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients included in this case series were collected from Clinica Dental Alcalá, were operated on by the same surgeon and fullfilled the inclusion and exclusion criteria.

You may qualify if:

  • Patients with a favorable bone density and favorable bone length but insufficient bone width that could compromise implant placement

You may not qualify if:

  • Smokers (\>10 cigarettes per day) and patients with severe systemic disease ( ASA III or IV - American Society of Anaesthesiology)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Jesús Torres, Associate

    Universidad Complutense de Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 3, 2021

First Posted

February 8, 2021

Study Start

September 11, 2016

Primary Completion

September 24, 2016

Study Completion

October 1, 2019

Last Updated

May 18, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share