Implant/Abutment Module Stability of Original vs Compatible Connections

April 27, 2019 updated by: David Peñarrocha Oltra, University of Valencia

Implant/Abutment Module Stability: a RCT Comparing Original vs Compatible Connections (Estabilidad Del módulo Implante/Pilar: ECA Comparando Conexiones Originales vs Compatibles).

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Valencia, Spain, 46010
        • Recruiting
        • Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Original CAD/CAM abutment
Patients will be rehabilitated using Sweden&Martina implants and original (Sweden&Martina) CAD/CAM abutments.
Device: Original CAD/CAM prosthetic abutment
Original (Sweden&Martina) CAD/CAM abutments will be screwed to the implants at 32N/cm.
Procedure: Local anesthesia
Infiltration of 4% articaine with 1:100,000 adrenalin (Inibsa).
Drug: Painkillers
Patients will be prescribed ibuprofen 600 mg three times per day for five days
Drug: Mouthwashes
Patients will be prescribed mouth-rinse with chlorhexidine 0.12% twice daily starting 3 days prior to surgery and for 2 weeks afterward
Device: Implant placement
Dental implants (Sweden & Martina, Padua, Italy) will be placed at crestal level and according to the manufacturer's instructions.
EXPERIMENTAL: Compatible CAD/CAM abutment
Patients will be rehabilitated using Sweden&Martina implants and compatible (New Ancorvis) CAD/CAM abutments.
Procedure: Local anesthesia
Infiltration of 4% articaine with 1:100,000 adrenalin (Inibsa).
Drug: Painkillers
Patients will be prescribed ibuprofen 600 mg three times per day for five days
Drug: Mouthwashes
Patients will be prescribed mouth-rinse with chlorhexidine 0.12% twice daily starting 3 days prior to surgery and for 2 weeks afterward
Device: Implant placement
Dental implants (Sweden & Martina, Padua, Italy) will be placed at crestal level and according to the manufacturer's instructions.
Device: Compatible CAD/CAM abutment
Compatible (New Ancorvis) CAD/CAM abutments will be screwed to the implants at 32N/cm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biological complications
Time Frame: 1 year
Proportion of cases with peri-implant disease.
1 year
Biomechanical complications
Time Frame: 1 year
Proportion of cases with fracture or loosening of screws
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbial loads
Time Frame: 1 year
Quantitative analysis of microbial species will be studied using Illumina protocol for 6S ribosomal RNA
1 year
Probing Pocket Depth
Time Frame: 1 year
Measured from the mucosal margin to the bottom of the probable pocket.
1 year
Modified Plaque Index
Time Frame: 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.
1 year
Bleeding on Probing
Time Frame: 1 year
Presence/absence of bleeding after probing.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valencia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 8, 2018

Primary Completion (ANTICIPATED)

December 1, 2019

Study Completion (ANTICIPATED)

July 1, 2020

Study Registration Dates

First Submitted

March 3, 2018

First Submitted That Met QC Criteria

May 13, 2018

First Posted (ACTUAL)

May 15, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 30, 2019

Last Update Submitted That Met QC Criteria

April 27, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H1497611651778

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bone Loss, Alveolar

Clinical Trials on Original CAD/CAM prosthetic abutment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe