Implant/Abutment Module Stability of Original vs Compatible Connections

University of Valencia

Status: Unknown

Conditions: Bone Loss, Alveolar; Dental Implant Failure Nos

Treatments: Device: Original CAD/CAM prosthetic abutment; Device: Implant placement; Procedure: Local anesthesia; Drug: Painkillers; Device: Compatible CAD/CAM abutment; Drug: Mouthwashes

Study type: Interventional

Funder types: Other

Identifiers

NCT03524872

H1497611651778

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Original CAD/CAM abutment

Active Comparator group

Description:

Patients will be rehabilitated using Sweden\&Martina implants and original (Sweden\&Martina) CAD/CAM abutments.

Treatment:

Device: Original CAD/CAM prosthetic abutment

Procedure: Local anesthesia

Drug: Painkillers

Device: Implant placement

Drug: Mouthwashes

Compatible CAD/CAM abutment

Experimental group

Description:

Patients will be rehabilitated using Sweden\&Martina implants and compatible (New Ancorvis) CAD/CAM abutments.

Treatment:

Procedure: Local anesthesia

Drug: Painkillers

Device: Implant placement

Drug: Mouthwashes

Device: Compatible CAD/CAM abutment