One-abutment One-time for Immediate Restoration Procedure in the Esthetic Zone

NCT ID: NCT04139512

Last Updated: 2019-10-25

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Objectives: The aim of this randomized control trial was to compare immediate restoration procedure with a one abutment one-time technique using a conventional versus full digital workflow. Surgical accuracy, provisional fit and patient reported outcome measures (PROMs) of.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Objectives: The aim of this randomized control trial was to compare immediate restoration procedure with a one abutment one-time technique using a conventional versus full digital workflow. Surgical accuracy, provisional fit and patient reported outcome measures (PROMs) of.

Material and method: Sites with single edentulous spaces and neighboring natural teeth were randomized into static computer-aided implant surgery (s-CAIS) or freehand placement implant surgery groups. In both groups, digital implant planning was performed using data from cone beam computed tomography (CBCT) and surfaces scans. In the s-CAIS group, a surgical guide was produced and used for fully guided implant surgery, while in the freehand group, the implants were placed in a freehand manner. the deviations in angles, shoulders and apexes between planned and actual implant positions were measured based on postoperative optic impressions. In the test group, a custom-made zirconia abutment and a provisional restoration were immediately placed using a full digital workflow whereas in the control group, a physical impression was taken, and the abutment and crown were placed 10 days post-surgery. Loading outcomes (interproximal contact, occlusal contact, white esthetic score (WES)) were assessed as the PROMs.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Implant Tissue Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The present study was designed as a randomized controlled trial comparing immediate restoration procedure in the esthetic zone with a one abutment one-time technique and using a conventional (control group) versus full digital workflow (test group),
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

guided surgery

test group, using a full digital workflow procedure

Group Type OTHER

guided surgery

Intervention Type PROCEDURE

placement of implant with local anesthesia using full guided surgery protocol versus free- hande one

conventional technic

free- hand technic to place implant

Group Type OTHER

conventionnel implant placement

Intervention Type PROCEDURE

placement of dental implant with conventionnal freehand technic

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

guided surgery

placement of implant with local anesthesia using full guided surgery protocol versus free- hande one

Intervention Type PROCEDURE

conventionnel implant placement

placement of dental implant with conventionnal freehand technic

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subjects must have voluntarily signed the informed consent form before any study related action
* Age \> 18 years old
* Single missing tooth or 2 non-adjacent missing teeth in the aesthetic area of the upper jaw. Patients who require an extraction and immediate implant placement can be included.
* Men/women
* Good systemic health (ASA I/II)
* No contra indication against oral surgical interventions
* At least 10 mm in the vertical dimension
* At least 7 mm in the bucco-palatal dimension
* No need for simultaneous bone augmentation procedure. However, a bone augmentation could have been realized 4 months prior to the digital planning of the surgery
* Healthy periodontal condition and full mouth plaque score (FMPS) lower or equal than 25%

Exclusion Criteria

* Autoimmune disease requiring medical treatment
* Medical conditions requiring prolonged use of steroids
* Use of bisphosphonates intravenously or more than 3 years of oral use
* Infection (local or systemic) Each infection will be evaluated prior to study procedure for suitability. Patients with gingivitis or local infection will undergo a medical treatment prior to its entrance to the study.

In case of systemic infection, the evaluation will be based on medical anamneses and, if necessary, will be referred to relevant medical tests.

* Current pregnancy or breastfeeding women
* Alcoholism or chronically drug abuse
* Immunocompromised patients
* Uncontrolled diabetes
* Smokers, more than 10 cigarettes per day


* Untreated local inflammation
* Mucosal disease or oral lesions
* History of local irradiation therapy in the head-neck area
* Persistent intraoral infection
* Patients with bad oral hygiene or unmotivated for normal home care
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Liege

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. France LAMBERT

Professor , doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU de Liège - Service de Médecine Dentaire

Liège, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B707201731117

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Connective Tissue Graft Versus Collagen Matrix
NCT04210596 ACTIVE_NOT_RECRUITING NA