Immediate Loading and Fully Guided Surgery: Single Implants

NCT ID: NCT04061694

Last Updated: 2020-03-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2019-08-31

Brief Summary

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To evaluate the overall treatment outcome of single implants installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning, during a 1-year follow-up period.

Detailed Description

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Conditions

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Osseointegration Failure of Dental Implant

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Digital Immediate loading

Single dental implant installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning and 3D printing

Group Type EXPERIMENTAL

Immediate loading, fully guided surgery and 3D printed restoration

Intervention Type PROCEDURE

Fully guided surgery installation of single dental implants. 3D printed restorations that were immediate loaded.

Immediate loading

Historic cohort subjected to immediate loading

Group Type OTHER

Immediate loading

Intervention Type PROCEDURE

Only subjected to immediate loading. Conventional procedure.

Interventions

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Immediate loading, fully guided surgery and 3D printed restoration

Fully guided surgery installation of single dental implants. 3D printed restorations that were immediate loaded.

Intervention Type PROCEDURE

Immediate loading

Only subjected to immediate loading. Conventional procedure.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* at least 18 years of age who had signed an informed consent
* in need of a single-tooth replacement of an incisor, canine or pre-molar in the maxilla.

Exclusion Criteria

* general contraindications for oral surgery
* patients with inadequate oral hygiene
* need for bone grafting or ridge augmentation.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Folktandvården Skåne AB

OTHER

Sponsor Role lead

Responsible Party

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Björn Gjelvold

Specialist in Oral Prosthodontics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ann Wennerberg, PhD

Role: STUDY_DIRECTOR

Göteborg University

Locations

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Centre of Dental Specialist Care

Lund, Skåne County, Sweden

Site Status

Countries

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Sweden

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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DIL001

Identifier Type: -

Identifier Source: org_study_id

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