SA Versus SOI Surfaces for Single Implant-supported Crown

NCT04073654 | Unknown

• 1 other identifier: SOI_1_RCT_MT
• Study Type: interventional
• Target: 100
• Locations: 8 countries
• Sites: 10

Brief Summary

The purpose of this randomized controlled trial is to compare clinical data and implant stability of immediately loaded TSIII Osstem implants with Sandblasted and Acid-etched (SA) surface versus implants with SA surface modified with pH buffering agent for the rehabilitation of single implant-supported crown.

Conditions

Dental Implant Failed; Bone Resorption

Keywords

Dental implants; Implant surfaces; Marginal bone loss

Outcome Measures

Primary Outcomes (3)

• Implant failure

  Implant removal for any reason will be considered an implant failure.

  From implant placement up to 60 months after loading

• Crown failure

  Crown replacement for any reason will be considered a crown failure.

  From crown delivery up to 60 months

• Complications

  Any complications will be recorded. Examples of biological complications are: nerve injury, fistula, peri-implantitis. Examples of biomechanical complications are fracture of the abutments screw, loosening of the crown, fracture of the ceramic.

  From implant placement up to 60 months after loading

Secondary Outcomes (6)

• Peri-implant marginal bone level (MBL) changes

  From implant placement up to 60 months after loading

• Probing pocket depth (PPD)

  From crown delivery up to 60 months

• Bleeding on probing (BOP)

  From crown delivery up to 60 months

• plaque index (PI)

  From implant placement up to 60 months after loading

• Implant stability quotient

  The ISQ values will be recorded at the time of implant placement (baseline) and then 1,2,3,4,5,6,7,8, and 12 weeks after implant placement.

Study Arms (2)

SA Implants

ACTIVE COMPARATOR

Dental implant with sandblasted and Acid-etched (SA) surface

Procedure: Placement of dental implants (surgical procedure)

SOI Implants

EXPERIMENTAL

Same dental implant with sandblasted and Acid-etched surface modified with pH buffering agent

Procedure: Placement of dental implants (surgical procedure)

Interventions

Placement of dental implants (surgical procedure) PROCEDURE

The two study implants have to be placed in the same surgical session according to similar procedures. Implants will be placed in the planned anatomic sites by using a flapless or a miniflap approach. Implants sites will be prepared based on the bone density, and according to the manufacturers's instruction by using the 122 Taper kit (Osstem Implant).

SA Implants; SOI Implants

Eligibility Criteria

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

You may qualify if:

• Any partially edentulous subject requiring at least two single (preferable non-adjacent) implant-supported crowns, being at least 18 year old and able to sign an informed consent will be screened for eligibility. Bone volumes should allow the placement of two implants at least 8.5 mm (maximum 10 mm) long and 4.5 mm (minimum 3.5 mm) wide, with a minimal insertion torque of 30 Ncm. Implants can be placed in previous post-extractive socket or in augmented bone, if at least 4 to 6 months have passed from the extraction or from augmentation procedures.

You may not qualify if:

• Patients unable to commit to 5 years follow-up.
• General contraindications to implant surgery.
• Less then 4 mm of keratinised gingiva crestally (at the implant sites).
• Immune-suppressed/compromised patients.
• Patients irradiated in the head and/or neck.
• Uncontrolled diabetes.
• Pregnancy or lactation.
• Untreated periodontal disease.
• Poor oral hygiene and motivation (full mouth bleeding and full mouth plaque index higher than 25%).
• Addiction to alcohol or drugs.
• Psychiatric problems and/or unrealistic expectations.
• Patients with an acute infection or suppuration in the site intended for implant placement.
• Patients needing any form of tissue augmentation at implant placement.
• Immediate post-extractive implants (implants can be placed after a 3-month healing period).
• Patients treated or under treatment with intravenous amino-bisphosphonates.

Sponsors & Collaborators

• Osstem AIC: lead

Study Sites (10)

Erta Xhanari

Tirana, Albania

RECRUITING

Elitsa Deliverska

Sofia, Bulgaria

RECRUITING

Fulvio Gatti

Milan, Italy

RECRUITING

Studio Odontoiatrico Marco Tallarico

Rome, 00151, Italy

RECRUITING

Leonardo Muzzi

Siena, Italy

RECRUITING

Łukasz Zadrożny

Warsaw, Poland

RECRUITING

Cesaltino Remedios

Fátima, Portugal

RECRUITING

Mircea

Craiova, Romania

RECRUITING

Andre de Waal

South Africa, South Africa

RECRUITING

Nicolas Widmer

Bern, Switzerland

RECRUITING

MeSH Terms

Conditions

Bone Resorption

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Marco Tallarico

CONTACT

+3280758769; me@studiomarcotallarico.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Implants have same macro design.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator

Model Details: Randomized controlled trial, split-mouth design

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: August 29, 2019
• Study Start: September 26, 2019
• Primary Completion: September 30, 2020
• Study Completion: October 15, 2021
• Last Updated: October 1, 2019

Record last verified: 2019-09

Locations

RO (1); AL (1); ZA (1); PT (1); PL (1); CH (1); IT (3); BU (1)