NCT02134743

Brief Summary

The aim of this study is to compare the stability of dental implant surface treated by sandblasting abrasive particles and acid subtraction (Control) with hydrophilic surfaces dental implants (chemical) and with a higher surface energy (Test) for a period of 16 weeks after installation. The evaluation will be made by analyzing the resonance frequency (Ostell). The hypothesis to be tested will be that implants with hydrophilic surface show increased secondary stability prior to the implants treated by acid etching.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 4, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 9, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 16, 2016

Status Verified

September 1, 2016

Enrollment Period

2.4 years

First QC Date

May 4, 2014

Last Update Submit

September 15, 2016

Conditions

Dental Implant FailedPre-osseointegration Failure of Dental Implant

Keywords

dental implantSurface energyHydrophilicityContact angleTitanium implant roughnessSurface conditioning

Outcome Measures

Primary Outcomes (1)

  • Loss of implant

    If the implant has been not integrated to the bone!

    4 months after surgery

Secondary Outcomes (1)

  • Implant stability (ISQ)

    Baseline, 1 to 16 weeks (4 months)

Study Arms (2)

Experimental Group

EXPERIMENTAL

At this group the patients will receive dental implants which have a modified SLA surface. These surface have wettability, which could improve and accelerate the osseointegration.Intervention: implant placement.

Procedure: Implant surgery

Control Group

ACTIVE COMPARATOR

The patient of this group will receive implant with conventional surface, SLA (Sandblasted and Acid-Etched Surface).Intervention: implant placement.

Procedure: Implant surgery

Interventions

Implant surgeryPROCEDURE

Dental implant surgery with two different kinds of implant surface (SLA and modified SLA)

Also known as: Neodent Neoporos (SLA surface), Neodent Acqua (Modified SLA surface)
Control GroupExperimental Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who had lost teeth in the posterior maxilla (region of premolars and molars, can be interspace or free end) in need of restoration with implant-supported prostheses
  • Able to understand and sign a waiver of informed free consent
  • Good oral hygiene
  • The receiving implant sites must have at least 3 months of healing after tooth extraction, proper height and width to install an implant of 4.3 mm in diameter and 10 mm of high.

You may not qualify if:

  • Patients requiring implants in the mandible or anterior maxilla (bone type I and II), or to submit any of the following conditions: general contraindications for surgical procedures, uncontrolled diabetes, severe bruxism or clenching, pregnant and lactating women, active periodontal disease, smoking and use of alcohol or drugs
  • Patients who underwent radiotherapy near the buccal cavity regions chemotherapy and those who use or have recently used bisphosphonates, such as alendronate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dentistry School - University of São Paulo

São Paulo, São Paulo, 05508-000, Brazil

Location

Related Publications (3)

  • Bornstein MM, Wittneben JG, Bragger U, Buser D. Early loading at 21 days of non-submerged titanium implants with a chemically modified sandblasted and acid-etched surface: 3-year results of a prospective study in the posterior mandible. J Periodontol. 2010 Jun;81(6):809-18. doi: 10.1902/jop.2010.090727.

    PMID: 20450357BACKGROUND

  • Schwarz F, Wieland M, Schwartz Z, Zhao G, Rupp F, Geis-Gerstorfer J, Schedle A, Broggini N, Bornstein MM, Buser D, Ferguson SJ, Becker J, Boyan BD, Cochran DL. Potential of chemically modified hydrophilic surface characteristics to support tissue integration of titanium dental implants. J Biomed Mater Res B Appl Biomater. 2009 Feb;88(2):544-57. doi: 10.1002/jbm.b.31233.

    PMID: 18837448BACKGROUND

  • Degidi M, Piattelli A, Shibli JA, Perrotti V, Iezzi G. Bone formation around one-stage implants with a modified sandblasted and acid-etched surface: human histologic results at 4 weeks. Int J Periodontics Restorative Dent. 2009 Dec;29(6):607-13.

    PMID: 20072738RESULT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD Student

Study Record Dates

First Submitted

May 4, 2014

First Posted

May 9, 2014

Study Start

April 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

September 16, 2016

Record last verified: 2016-09

Locations

BR(1)