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Implant/Abutment Module Stability of Original vs Compatible Connections

NCT ID: NCT03524872

Last Updated: 2019-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-08

Study Completion Date

2020-07-31

Brief Summary

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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

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Conditions

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Bone Loss, Alveolar Dental Implant Failure Nos

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
The devices will have the same shape and will be delivered to the surgeon unlabeled in an identical sterile envelope.

Study Groups

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Original CAD/CAM abutment

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

Group Type ACTIVE_COMPARATOR

Original CAD/CAM prosthetic abutment

Intervention Type DEVICE

Original (Sweden\&Martina) CAD/CAM abutments will be screwed to the implants at 32N/cm.

Local anesthesia

Intervention Type PROCEDURE

Infiltration of 4% articaine with 1:100,000 adrenalin (Inibsa).

Painkillers

Intervention Type DRUG

Patients will be prescribed ibuprofen 600 mg three times per day for five days

Mouthwashes

Intervention Type DRUG

Patients will be prescribed mouth-rinse with chlorhexidine 0.12% twice daily starting 3 days prior to surgery and for 2 weeks afterward

Implant placement

Intervention Type DEVICE

Dental implants (Sweden \& Martina, Padua, Italy) will be placed at crestal level and according to the manufacturer's instructions.

Compatible CAD/CAM abutment

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

Group Type EXPERIMENTAL

Compatible CAD/CAM abutment

Intervention Type DEVICE

Compatible (New Ancorvis) CAD/CAM abutments will be screwed to the implants at 32N/cm.

Local anesthesia

Intervention Type PROCEDURE

Infiltration of 4% articaine with 1:100,000 adrenalin (Inibsa).

Painkillers

Intervention Type DRUG

Patients will be prescribed ibuprofen 600 mg three times per day for five days

Mouthwashes

Intervention Type DRUG

Patients will be prescribed mouth-rinse with chlorhexidine 0.12% twice daily starting 3 days prior to surgery and for 2 weeks afterward

Implant placement

Intervention Type DEVICE

Dental implants (Sweden \& Martina, Padua, Italy) will be placed at crestal level and according to the manufacturer's instructions.

Interventions

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Original CAD/CAM prosthetic abutment

Original (Sweden\&Martina) CAD/CAM abutments will be screwed to the implants at 32N/cm.

Intervention Type DEVICE

Compatible CAD/CAM abutment

Compatible (New Ancorvis) CAD/CAM abutments will be screwed to the implants at 32N/cm.

Intervention Type DEVICE

Local anesthesia

Infiltration of 4% articaine with 1:100,000 adrenalin (Inibsa).

Intervention Type PROCEDURE

Painkillers

Patients will be prescribed ibuprofen 600 mg three times per day for five days

Intervention Type 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

Intervention Type DRUG

Implant placement

Dental implants (Sweden \& Martina, Padua, Italy) will be placed at crestal level and according to the manufacturer's instructions.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Valencia

OTHER

Sponsor Role lead

Responsible Party

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David Peñarrocha Oltra

Assistanat Postdoctoral Lecturer (Profesor Ayudante Doctor)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis

Valencia, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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David Peñarrocha Oltra

Role: CONTACT

Phone: 0034649952560

Email: [email protected]

Facility Contacts

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David Peñarrocha Oltra

Role: primary

Other Identifiers

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H1497611651778

Identifier Type: -

Identifier Source: org_study_id