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OpenTrials
Completed

NCT Number: NCT03987646

The Vestibular Socket Therapy : A Novel Concept for Immediate Implant Placement in Defective Fresh Extraction Sites

This article aims to provide a non- staged treatment protocol to placing dental implants in compromised fresh sockets in the aesthetic zone.

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Key information

Conditions

Immediate Implants

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Private Practice Clinic

Alexandria, Egypt

About this study

This is a site-specific therapy uses study a slowly resorbing regenerative barrier (shield) to augment any thin or deficient labial plate of bone, enhances the overlying soft tissue quality and quantity at the same time with implant fixture placement using a computer-guided surgical template.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A hopeless single tooth in the maxillary anterior region
  • Sufficient apical bone to allow adequate anchorage/primary stability of the implant
  • had natural teeth present adjacent to the tooth being replaced

Exclusion criteria

  • Presence of acute infection
  • Impossibility of reaching adequate implant primary stability in the native
  • Smokers of > 10 cigarettes
  • Antitumor chemotherapy or radiotherapy in the previous year

Treatment and study plan

Non-staged vestibular fresh socket therapy

Procedure

a slowly resorbable membrane shield is placed above the labial plate of bone so that when the thin labial plate started its resorption process the shield remains till a complete gap fill occurred thus leading to a thicker labial plate of bone or it preserves the socket architecture until a complete bone fill occurred inside the socket

Other names: osteoflex

Primary outcomes

  1. radiographic buccal bone thickness

    Time frame: 6 months

    preoperative and follow up CBCTs are superimposed on each other and buccal bone thickness is measure at 3 similar points on both CBCTs and then a mean is calculated

  2. radiographic buccal bone height

    Time frame: 6 months

    preoperative and follow up CBCTs are superimposed on each other and buccal bone height is measured in relation to implant shoulder level

Secondary outcomes

  1. final esthetic outcome of soft tissue

    Time frame: 6 months

    Pink esthetic score. based on subjective assessment of mesial papilla, distal papilla, midfacial level, midfacial contour, alveolar process deficiency, soft tissue color and texture. each item is given a score between 0 and 2, where 0 is the worst and 2 is the best outcome. Then, a final score ranging between 0-14 is calculated

Sponsors and collaborators

Lead sponsor

Nourhan M.Aly

Other

Collaborators

  • Alexandria University

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 17, 2019
Registry last updated
Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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