Implant/Abutment Module Stability of Original vs Compatible Connections

Bone Loss, Alveolar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03524872
• Other study ID #: H1497611651778
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2018
• Est. completion date: July 2020

Study information

• Verified date: April 2019
• Source: University of Valencia
• Contact: David Peñarrocha Oltra
• Phone: 0034649952560
• Email: david.penarrocha[@]uv.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Bone Loss, Alveolar
• Dental Implant Failure Nos

Intervention

Device:
• Original CAD/CAM prosthetic abutment
Original (Sweden&Martina) CAD/CAM abutments will be screwed to the implants at 32N/cm.
• 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
• 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.

Locations

Country	Name	City	State
Spain	Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biological complications	Proportion of cases with peri-implant disease.	1 year
Primary	Biomechanical complications	Proportion of cases with fracture or loosening of screws	1 year
Secondary	Microbial loads	Quantitative analysis of microbial species will be studied using Illumina protocol for 6S ribosomal RNA	1 year
Secondary	Probing Pocket Depth	Measured from the mucosal margin to the bottom of the probable pocket.	1 year
Secondary	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.	1 year
Secondary	Bleeding on Probing	Presence/absence of bleeding after probing.	1 year