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Implant/Abutment Module Stability of Original vs Compatible Connections

Primary Purpose

Bone Loss, Alveolar, Dental Implant Failure Nos

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Original CAD/CAM prosthetic abutment
Compatible CAD/CAM abutment
Local anesthesia
Painkillers
Mouthwashes
Implant placement
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Loss, Alveolar

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Clínica Odontológica de la Universitat de Valencia, Fundación Lluis AlcanyisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Original CAD/CAM abutment

Compatible CAD/CAM abutment

Arm Description

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

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

Outcomes

Primary Outcome Measures

Biological complications
Proportion of cases with peri-implant disease.
Biomechanical complications
Proportion of cases with fracture or loosening of screws

Secondary Outcome Measures

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

Full Information

First Posted
March 3, 2018
Last Updated
April 27, 2019
Sponsor
University of Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT03524872
Brief Title
Implant/Abutment Module Stability of Original vs Compatible Connections
Official Title
Implant/Abutment Module Stability: a RCT Comparing Original vs Compatible Connections (Estabilidad Del módulo Implante/Pilar: ECA Comparando Conexiones Originales vs Compatibles).
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 8, 2018 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
July 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Loss, Alveolar, Dental Implant Failure Nos

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The devices will have the same shape and will be delivered to the surgeon unlabeled in an identical sterile envelope.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Original CAD/CAM abutment
Arm Type
Active Comparator
Arm Description
Patients will be rehabilitated using Sweden&Martina implants and original (Sweden&Martina) CAD/CAM abutments.
Arm Title
Compatible CAD/CAM abutment
Arm Type
Experimental
Arm Description
Patients will be rehabilitated using Sweden&Martina implants and compatible (New Ancorvis) CAD/CAM abutments.
Intervention Type
Device
Intervention Name(s)
Original CAD/CAM prosthetic abutment
Intervention Description
Original (Sweden&Martina) CAD/CAM abutments will be screwed to the implants at 32N/cm.
Intervention Type
Device
Intervention Name(s)
Compatible CAD/CAM abutment
Intervention Description
Compatible (New Ancorvis) CAD/CAM abutments will be screwed to the implants at 32N/cm.
Intervention Type
Procedure
Intervention Name(s)
Local anesthesia
Intervention Description
Infiltration of 4% articaine with 1:100,000 adrenalin (Inibsa).
Intervention Type
Drug
Intervention Name(s)
Painkillers
Intervention Description
Patients will be prescribed ibuprofen 600 mg three times per day for five days
Intervention Type
Drug
Intervention Name(s)
Mouthwashes
Intervention Description
Patients will be prescribed mouth-rinse with chlorhexidine 0.12% twice daily starting 3 days prior to surgery and for 2 weeks afterward
Intervention Type
Device
Intervention Name(s)
Implant placement
Intervention Description
Dental implants (Sweden & Martina, Padua, Italy) will be placed at crestal level and according to the manufacturer's instructions.
Primary Outcome Measure Information:
Title
Biological complications
Description
Proportion of cases with peri-implant disease.
Time Frame
1 year
Title
Biomechanical complications
Description
Proportion of cases with fracture or loosening of screws
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Microbial loads
Description
Quantitative analysis of microbial species will be studied using Illumina protocol for 6S ribosomal RNA
Time Frame
1 year
Title
Probing Pocket Depth
Description
Measured from the mucosal margin to the bottom of the probable pocket.
Time Frame
1 year
Title
Modified Plaque Index
Description
Presence/absence of plaque at the cervical part of the implant-supported crown scored by running a probe along the implant-supported crown surface.
Time Frame
1 year
Title
Bleeding on Probing
Description
Presence/absence of bleeding after probing.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Peñarrocha Oltra
Phone
0034649952560
Email
david.penarrocha@uv.es
Facility Information:
Facility Name
Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Peñarrocha Oltra
Phone
649952560
Email
david.penarrocha@uv.es

12. IPD Sharing Statement

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Implant/Abutment Module Stability of Original vs Compatible Connections

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