Clinical trial NCT04139512: One-abutment One-time for Immediate Restoration Procedure in the Esthetic Zone
Official title: One-abutment One-time for Immediate Restoration Procedure in the Esthetic Zone: A Randomized Controlled Trial Comparing Conventional Versus Full Digital Workflow
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Implant Tissue Failure
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of the surgical accuracy
timeFrame: The day of the surgery
measure: Clinical fit of the provisional restoration measurements
timeFrame: 10 days post surgery
Secondary outcomes:
measure: WES
timeFrame: 10 days post surgery
measure: Patient-reported outcomes measures (PROMs)
timeFrame: 10 days post surgery
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: CHU de Liège - Service de Médecine Dentaire
Study officials:
References: