SA Versus SOI Surfaces for Single Implant-supported Crown

September 29, 2019 updated by: Marco Tallarico, Osstem AIC

Clinical Evaluation and Primary Stability of Early Loaded Implants With Sandblasted and Acid-etched Surface Versus Implants With SA Surface Modified With pH Buffering Agent: a Multicenter Randomized Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study aimed to evaluate if there are some benefits using novel implant surface. This surface should improve the secondary implant stability, reducing the overall time needed for the osseointegration. main benefits in clinical practice should be reduced treatment time.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Patients referred only for implant placement if the follow-up cannot be done at the treatment center.
  • Patients participating in other studies, if the present protocol could not be fully adhered to.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: SA Implants
Dental implant with sandblasted and Acid-etched (SA) surface
Procedure: Placement of dental implants (surgical 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).
EXPERIMENTAL: SOI Implants
Same dental implant with sandblasted and Acid-etched surface modified with pH buffering agent
Procedure: Placement of dental implants (surgical 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant failure
Time Frame: From implant placement up to 60 months after loading
Implant removal for any reason will be considered an implant failure.
From implant placement up to 60 months after loading
Crown failure
Time Frame: From crown delivery up to 60 months
Crown replacement for any reason will be considered a crown failure.
From crown delivery up to 60 months
Complications
Time Frame: From implant placement up to 60 months after loading
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peri-implant marginal bone level (MBL) changes
Time Frame: From implant placement up to 60 months after loading
It will be assessed on periapical radiographs taken with the paralleling technique. The distance between marginal bone level and implant/abutment junction, will be measured at both mesial and distal sides and averaged. Bone level changes at single implants will be averaged at group level. Non-digital radiographs will be scanned, digitized, and stored in a personal computer. Peri-implant marginal bone levels will be measured using the Scion Image (Scion Corporation, Frederick, MD, USA) software. The software will be calibrated for every single image using the known distance of the implant neck. Measurements of the mesial and distal bone crest level adjacent to each implant will be made to the nearest 0.01 mm. Reference points for the linear measurements will be: the coronal margin of the implant collar and the most coronal point of bone-to-implant contact.
From implant placement up to 60 months after loading
Probing pocket depth (PPD)
Time Frame: From crown delivery up to 60 months
Probing pocket depth will be measured by a blinded operator, with a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing, Chicago, IL, USA). Three vestibular and three lingual values will be collected and averaged for each implant.
From crown delivery up to 60 months
Bleeding on probing (BOP)
Time Frame: From crown delivery up to 60 months
Bleeding on probing will be measured by a blinded operator, with a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing, Chicago, IL, USA). Three vestibular and three lingual values will be collected and averaged for each implant.
From crown delivery up to 60 months
plaque index (PI)
Time Frame: From implant placement up to 60 months after loading
Plaque index will be measured by a blinded operator, with a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing, Chicago, IL, USA) at delivery of the definitive crowns, 1, 3, and 5 years follow-up in function. Three vestibular and three lingual values will be collected for each implant.
From implant placement up to 60 months after loading
Implant stability quotient
Time Frame: 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.
The implant stability quotient will be recorded by the blind outcome assessor using resonance frequency analysis (Osstell Mentor; Osstell, Goteborg, Sweden).7 Buccopalatal and mesiodistal measurements will be taken and averaged, with the result being displayed by the device in ISQ units, ranging from 1 to 100.
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.
Pink Esthetic Score
Time Frame: From crown delivery up to 60 months
The aesthetic evaluation will be performed according to the pink aesthetic score on the vestibular and occlusal pictures taken including at least one adjacent tooth per side.8 The values will be assessed at definitive prosthesis delivery, and then early up to the end of the follow-up. Seven variables (mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture) will be assessed with a 2-1-0 score (2 being best and 0 being poorest) by the same blinded dentist.
From crown delivery up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Osstem AIC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 26, 2019

Primary Completion (ANTICIPATED)

September 30, 2020

Study Completion (ANTICIPATED)

October 15, 2021

Study Registration Dates

First Submitted

June 27, 2019

First Submitted That Met QC Criteria

August 27, 2019

First Posted (ACTUAL)

August 29, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 1, 2019

Last Update Submitted That Met QC Criteria

September 29, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOI_1_RCT_MT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bone Resorption

Clinical Trials on Placement of dental implants (surgical procedure)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe