Immediate Implant Outcomes With and Without Bone Augmentation

NCT ID: NCT05157009

Last Updated: 2023-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Tooth Loss Bone Loss, Alveolar Dental Diseases Dental Trauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Immediate implant placement without reconstruction

Immediate implant placement after tooth extraction

Group Type OTHER

implant placement

Intervention Type PROCEDURE

autogenous bone reconstruction of damaged socket \& simultaneous implant placement

Immediate implant placement with reconstruction

Immediate implant placement and simultaneous bone reconstruction after tooth extraction

Group Type OTHER

implant placement

Intervention Type PROCEDURE

autogenous bone reconstruction of damaged socket \& simultaneous implant placement

Interventions

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implant placement

autogenous bone reconstruction of damaged socket \& simultaneous implant placement

Intervention Type PROCEDURE

Other Intervention Names

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bone reconstruction

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Verdugo, Fernando, DDS

INDIV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Verdugo, PhD

Role: PRINCIPAL_INVESTIGATOR

Verdugo, Fernando, DDS

Locations

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FV, DDS,Corp

San Gabriel, California, United States

Site Status

Countries

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United States

Other Identifiers

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VerdugoF

Identifier Type: -

Identifier Source: org_study_id

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