Implant/Abutment Module Stability of Original vs Compatible Connections

Sponsor

University of Valencia (Other)

Overall Status

Unknown status

CT.gov ID

NCT03524872

Collaborator

(none)

Enrollment

Location

Arms

29.7

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bone Loss, Alveolar Dental Implant Failure Nos	Device: Original CAD/CAM prosthetic abutment Device: Compatible CAD/CAM abutment Procedure: Local anesthesia Drug: Painkillers Drug: Mouthwashes Device: Implant placement	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

The devices will have the same shape and will be delivered to the surgeon unlabeled in an identical sterile envelope.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 8, 2018

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Jul 1, 2020

Arms and Interventions

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.	Device: Compatible CAD/CAM abutment Compatible (New Ancorvis) 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.

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.

Device: Compatible CAD/CAM abutment

Compatible (New Ancorvis) 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.

Outcome Measures

Primary Outcome Measures

Biological complications [1 year]
Proportion of cases with peri-implant disease.
Biomechanical complications [1 year]
Proportion of cases with fracture or loosening of screws

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis	Valencia		Spain	46010

Sponsors and Collaborators

University of Valencia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

David Peñarrocha Oltra, Assistanat Postdoctoral Lecturer (Profesor Ayudante Doctor), University of Valencia

ClinicalTrials.gov Identifier:

NCT03524872

Other Study ID Numbers:

H1497611651778

First Posted:

May 15, 2018

Last Update Posted:

Apr 30, 2019

Last Verified:

Apr 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Alveolar Bone Loss

Analgesics

Study Results

No Results Posted as of Apr 30, 2019