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Implant/Abutment Module Stability of Original vs Compatible Connections

U

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

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

Trial contacts and locations

1

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Central trial contact

David Peñarrocha Oltra

Data sourced from clinicaltrials.gov

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