Modified Periostal Pocket Flap Technique

Sponsor
Universidad Complutense de Madrid (Other)
Overall Status
Completed
CT.gov ID
NCT04744012
Collaborator
(none)
8
36.6

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
  • Procedure: Modified Periostal Pocket Flap Technique

Detailed 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.

Study Design

Study Type:
Observational
Actual Enrollment :
8 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Modified Periostal Pocket Flap Technique: a Case Series
Actual Study Start Date :
Sep 11, 2016
Actual Primary Completion Date :
Sep 24, 2016
Actual Study Completion Date :
Oct 1, 2019

Arms and Interventions

Arm 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Volume of bone augmentation [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Universidad Complutense de Madrid

Investigators

  • Principal Investigator: Jesús Torres, Associate, Universidad Complutense de Madrid

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jesús Torres García Denche, Associate Professor, Universidad Complutense de Madrid
ClinicalTrials.gov Identifier:
NCT04744012
Other Study ID Numbers:
  • P-15/568
First Posted:
Feb 8, 2021
Last Update Posted:
May 18, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jesús Torres García Denche, Associate Professor, Universidad Complutense de Madrid

Study Results

No Results Posted as of May 18, 2022