Immediate Implant Outcomes With and Without Bone Augmentation

April 24, 2023 updated by: Verdugo, Fernando, DDS

Immediate Implants in Damaged Sockets With Simultaneous Bone Reconstruction vs. Immediate Implants in Intact Sockets and no Reconstruction

To evaluate immediate implant placement feasibility and esthetic outcomes in severely damaged sockets that received simultaneously bone reconstruction (cortical bone shield) and implant placement versus intact sockets that needed no reconstruction and had immediate implant placement.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The present clinical trial aims at demonstrating facial bone regeneration on sites that presented large buccal bone dehiscences & vertical bone loss and evaluate the feasibility of performing simultaneous bone augmentation and implant placement, comparing the outcomes with sites that had intact sockets that did not require reconstruction. A secondary objective was to evaluate pink esthetics and marginal bone levels at final follow-up.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Gabriel, California, United States, 91776
        • FV, DDS,Corp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • individuals 20 Years and older
  • Patients requiring single implants to replace missing teeth to restore masticatory function and esthetics.
  • ASA1 or ASA2 (American Society of Anesthesiologists)
  • Healthy individuals with good oral hygiene and motivation
  • No systemic uncontrolled diseases
  • Not taking drugs known to modify bone metabolism

Exclusion Criteria:

  • Individuals with untreated & generalized severe periodontitis
  • Smokers (>5 cigarettes/day)
  • Poor oral hygiene
  • Diabetes (HbA1C >6.5% as cutoff value)
  • Uncontrolled cardiovascular disease
  • Poor overall health (ASA IV)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Immediate implant placement without reconstruction
Immediate implant placement after tooth extraction
Procedure: implant placement
autogenous bone reconstruction of damaged socket & simultaneous implant placement
Other Names:
  • bone reconstruction
Other: Immediate implant placement with reconstruction
Immediate implant placement and simultaneous bone reconstruction after tooth extraction
Procedure: implant placement
autogenous bone reconstruction of damaged socket & simultaneous implant placement
Other Names:
  • bone reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate implant placement feasibility & success rate at 12 months
Time Frame: 12 months
evaluate implant success following Karoussis et al. success criteria
12 months
Number of individuals with low pink esthetic outcomes as assessed by pink esthetic scores (PES)
Time Frame: 12 months
pink esthetics scores (PES) as proposed by Belser et al. Values 0-10 were 10 is the best esthetic outcome.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant transparency: clinical presence or absence
Time Frame: 12 months
Visual evaluation of facial mucosal implant transparency at 12 months: positive or negative
12 months
Number of participants with >0.2mm of marginal bone levels
Time Frame: 12 months
evaluate radiographic marginal bone levels at 12 months with >0.2mm of bone loss
12 months
Band of keratinized tissue: clinical presence or absence
Time Frame: 12 months
evaluate the presence of facial keratinized tissue on the implant sites >2 or <2mm
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Verdugo, Fernando, DDS

Investigators

  • Principal Investigator: Verdugo, PhD, Verdugo, Fernando, DDS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

November 8, 2021

First Submitted That Met QC Criteria

November 30, 2021

First Posted (Actual)

December 14, 2021

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 24, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VerdugoF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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