Implant/Abutment Module Stability of Original vs Compatible Connections

NCT03524872 | Unknown

• 1 other identifier: H1497611651778
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Loss, Alveolar; Dental Implant Failure Nos

Outcome Measures

Primary Outcomes (2)

• Biological complications

  Proportion of cases with peri-implant disease.

  1 year

• Biomechanical complications

  Proportion of cases with fracture or loosening of screws

  1 year

Secondary Outcomes (4)

• Microbial loads

  1 year

• Probing Pocket Depth

  1 year

• Modified Plaque Index

  1 year

• Bleeding on Probing

  1 year

Study Arms (2)

Original CAD/CAM abutment

ACTIVE COMPARATOR

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

Device: Original CAD/CAM prosthetic abutment; Procedure: Local anesthesia; Drug: Painkillers; Drug: Mouthwashes; Device: Implant placement

Compatible CAD/CAM abutment

EXPERIMENTAL

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

Device: Compatible CAD/CAM abutment; Procedure: Local anesthesia; Drug: Painkillers; Drug: Mouthwashes; Device: Implant placement

Interventions

Original CAD/CAM prosthetic abutment DEVICE

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

Original CAD/CAM abutment

Compatible CAD/CAM abutment DEVICE

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

Compatible CAD/CAM abutment

Local anesthesia PROCEDURE

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

Compatible CAD/CAM abutment; Original CAD/CAM abutment

Painkillers DRUG

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

Compatible CAD/CAM abutment; Original CAD/CAM abutment

Mouthwashes DRUG

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

Compatible CAD/CAM abutment; Original CAD/CAM abutment

Implant placement DEVICE

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

Compatible CAD/CAM abutment; Original CAD/CAM abutment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis

Valencia, 46010, Spain

RECRUITING

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Anesthesia, Local; Acetaminophen; Mouthwashes

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

David Peñarrocha Oltra

CONTACT

0034649952560; david.penarrocha@uv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The devices will have the same shape and will be delivered to the surgeon unlabeled in an identical sterile envelope.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistanat Postdoctoral Lecturer (Profesor Ayudante Doctor)

Study Record Dates

• First Submitted: March 3, 2018
• First Posted: May 15, 2018
• Study Start: January 8, 2018
• Primary Completion: December 1, 2019
• Study Completion: July 1, 2020
• Last Updated: April 30, 2019

Record last verified: 2019-04

Locations

ES (1)