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

One-abutment One-time for Immediate Restoration Procedure in the Esthetic Zone: A Randomized Controlled Trial Comparing Conventional Versus Full Digital Workflow

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.

Study Overview

• Status: Completed
• Conditions: Implant Tissue Failure
• Intervention / Treatment: Procedure: guided surgery; Procedure: conventionnel implant placement

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • CHU de Liège - Service de Médecine Dentaire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Local exclusion criteria

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: guided surgery; test group, using a full digital workflow procedure	Procedure: guided surgery; placement of implant with local anesthesia using full guided surgery protocol versus free- hande one
Other: conventional technic; free- hand technic to place implant	Procedure: conventionnel implant placement; placement of dental implant with conventionnal freehand technic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the surgical accuracy	The STL files (stereolithography files) were superimposed with pre-operative CBCT (Cone beam computed tomography) images using automated surface best fit matching with the iterative closest point algorithm in the treatment evaluation mode, coDiagnostiX® software version 9.7 (Dental Wings Inc). The mean deviations at the implant shoulder and apex between the planned and actual implant positions were measured in millimeters (mm), as well as the divergence of the implant axis in degrees. All measurements were performed by a single dentist, who conducted the virtual implant planning in all cases.	The day of the surgery
Clinical fit of the provisional restoration measurements	The measurements were based on the adaptation of the provisional crown. Interproximal contacts were evaluated according to the criteria described by Syrek (Syrek et al., 2010). Dental floss (Johnson & Johnson Reach®, Waxed dentotape, New Brunswick, NJ, USA) was used to check the interproximal contact. A score from 1 to 4 was given to the fitting criteria (the higher the score, the better the adaptation).	10 days post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WES	To evaluate the esthetic outcomes of the provisional crown, the White Esthetic Score (WES) was reported. The highest WES score was 10, which represented a close match with the clinical single-tooth crown present at the contralateral natural tooth or neighboring teeth. The WES was evaluated by a blinded prosthodontic, based on photography.	10 days post surgery
Patient-reported outcomes measures (PROMs)	PROMs were obtained using a VAS form immediately after the immediate restoration of the implant. Five questions were used: Do you feel your provisional tooth as a natural tooth? (0 = not at all to 10, absolutely).; Do you find your provisional tooth looks like a natural tooth? (0 = not at all to 10, absolutely).; How much discomfort did you feel during the physical impression? (0 = little or 10, a lot) for the control group.How much discomfort did you feel during the optical impression? (0 = little to 10, a lot) for the test group.; Would you be willing to undergo this treatment again? (0= not at all to 10, absolutely).; Are you satisfied with the aesthetics outcomes of your provisional tooth. (0 = not at all to 10, absolutely).	10 days post surgery

Collaborators and Investigators

• Sponsor: University of Liege

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: August 19, 2019
• First Submitted That Met QC Criteria: October 24, 2019
• First Posted (Actual): October 25, 2019

Study Record Updates

• Last Update Posted (Actual): October 25, 2019
• Last Update Submitted That Met QC Criteria: October 24, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: B707201731117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No