Clinical trial NCT02134743: Evaluation of the Stability of Implants With Two Different Surface Treatments
Official title: Evaluation of the Stability of Implants With Two Different Surface Treatments: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implant Failed
Pre-osseointegration Failure of Dental Implant
Keywords: dental implant
Surface energy
Hydrophilicity
Contact angle
Titanium implant roughness
Surface conditioning
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2014-05-09
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Detailed description: The selected patients will be randomly divided into two groups by computer-generated list. The control group will receive implant surface treated by acid etching and test group receive implants with hydrophilic surface (Test). Both the test and the control group will undergo the same pre-surgical, surgical and post-surgical protocols.

The evaluation of the implant will be done by the analysis of resonant frequency wich will be performed on each implant with Osstell (Integration Diagnostics AB, Goteborg, Sweden) immediately after implant placement (baseline) and at follow-up sessions (1st, 2nd, 3rd, 5th, 8th, 12th and 16th weeks after installation) and coefficient of implant stability (ISQ) on these dates will be measured on a scale from 0 to 100. The smartpeg be used with special developed Healing without the use of pillars or intermediaries.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Loss of implant
timeFrame: 4 months after surgery
Secondary outcomes:
measure: Implant stability (ISQ)
timeFrame: Baseline, 1 to 16 weeks (4 months)
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Dentistry School - University of São Paulo
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.