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

NCT04139512 | Completed Phase 4 DMC

• 1 other identifier: B707201731117
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Implant Tissue Failure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• WES

  10 days post surgery

• Patient-reported outcomes measures (PROMs)

  10 days post surgery

Study Arms (2)

guided surgery

OTHER

test group, using a full digital workflow procedure

Procedure: guided surgery

conventional technic

OTHER

free- hand technic to place implant

Procedure: conventionnel implant placement

Interventions

guided surgery PROCEDURE

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

guided surgery

conventionnel implant placement PROCEDURE

placement of dental implant with conventionnal freehand technic

conventional technic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

CHU de Liège - Service de Médecine Dentaire

Liège, 4000, Belgium

Location

MeSH Terms

Interventions

Surgery, Computer-Assisted

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor , doctor

Model Details: 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),

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: October 25, 2019
• Study Start: June 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: August 1, 2019
• Last Updated: October 25, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)