Implant/Abutment Module Stability of Original vs Compatible Connections

Not Applicable

• Conditions: Dental Implant Failure Nos; Bone Loss, Alveolar
• Interventions: Device: Original CAD/CAM prosthetic abutment; Device: Compatible CAD/CAM abutment; Procedure: Local anesthesia; Drug: Painkillers; Drug: Mouthwashes; Device: Implant placement

• Registration Number: NCT03524872
• Lead Sponsor: University of Valencia

Brief Summary

Together with materials and type of retention, the stability of the implant abutment connection represents one of the key factor for the success rate of an implant supported restoration. The recent diffusion of high quality and easy to use CAD/CAM systems has contributed to market launch of a number of competing companies that offer the so called "clonical" or "compatible" restorative components. Although they are claimed to be identical, the original abutments are supposed to present maximum accuracy and consequently lower microleakage.

The aim of the present randomized controlled trial will be to analyze the implant abutment junction stability comparing implant-supported crowns restored with original components and compatible non-original abutments.

The hypothesis is that original components will present significantly better stability than non-original abutments.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-08
• Study First Submitted: 2018-03-03
• Study First Submitted QC: 2018-05-13
• Study First Posted: 2018-05-15
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-27
• Last Update Posted: 2019-04-30
• Primary Completion: 2019-12
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Any healthy patient scheduled for an implant-supported restoration will be considered for inclusion in this study, independently of the implant and prosthetic protocols used.

Exclusion Criteria

• general medical contraindications to oral surgery (American Society of Anesthesiologist, ASA, class III or IV),
• patients <18 years of age,
• smoking habit (>10 cigarettes/day),
• sites with acute infection or requiring regenerative procedures,
• Full Mouth Plaque Score
• Full Mouth Bleeding Score >25 %,
• pregnant and lactating.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Compatible CAD/CAM abutment	Local anesthesia	Patients will be rehabilitated using Sweden\&Martina implants and compatible (New Ancorvis) CAD/CAM abutments.
Original CAD/CAM abutment	Original CAD/CAM prosthetic abutment	Patients will be rehabilitated using Sweden\&Martina implants and original (Sweden\&Martina) CAD/CAM abutments.
Original CAD/CAM abutment	Painkillers	Patients will be rehabilitated using Sweden\&Martina implants and original (Sweden\&Martina) CAD/CAM abutments.
Original CAD/CAM abutment	Mouthwashes	Patients will be rehabilitated using Sweden\&Martina implants and original (Sweden\&Martina) CAD/CAM abutments.
Original CAD/CAM abutment	Local anesthesia	Patients will be rehabilitated using Sweden\&Martina implants and original (Sweden\&Martina) CAD/CAM abutments.
Compatible CAD/CAM abutment	Compatible CAD/CAM abutment	Patients will be rehabilitated using Sweden\&Martina implants and compatible (New Ancorvis) CAD/CAM abutments.
Original CAD/CAM abutment	Implant placement	Patients will be rehabilitated using Sweden\&Martina implants and original (Sweden\&Martina) CAD/CAM abutments.
Compatible CAD/CAM abutment	Mouthwashes	Patients will be rehabilitated using Sweden\&Martina implants and compatible (New Ancorvis) CAD/CAM abutments.
Compatible CAD/CAM abutment	Painkillers	Patients will be rehabilitated using Sweden\&Martina implants and compatible (New Ancorvis) CAD/CAM abutments.
Compatible CAD/CAM abutment	Implant placement	Patients will be rehabilitated using Sweden\&Martina implants and compatible (New Ancorvis) CAD/CAM abutments.

Primary Outcome Measures

Name	Time	Method
Biological complications	1 year	Proportion of cases with peri-implant disease.
Biomechanical complications	1 year	Proportion of cases with fracture or loosening of screws

Secondary Outcome Measures

Name	Time	Method
Bleeding on Probing	1 year	Presence/absence of bleeding after probing.
Probing Pocket Depth	1 year	Measured from the mucosal margin to the bottom of the probable pocket.
Modified Plaque Index	1 year	Presence/absence of plaque at the cervical part of the implant-supported crown scored by running a probe along the implant-supported crown surface.
Microbial loads	1 year	Quantitative analysis of microbial species will be studied using Illumina protocol for 6S ribosomal RNA

Trial Locations

Locations (1)

Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis; 🇪🇸 Valencia, Spain