Evaluation of the Stability of Implants With Two Different Surface Treatments

Dental Implant Failed Clinical Trial

Official title:

Evaluation of the Stability of Implants With Two Different Surface Treatments: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02134743
• Other study ID #: 18911913.7.0000.0075
• Status: Completed
• Phase: N/A
• First received: May 4, 2014
• Last updated: September 15, 2016
• Start date: April 2014
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministerio da Saude (Plataforma Brasil)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Dental Implant Failed
• Pre-osseointegration Failure of Dental Implant

Intervention

Procedure:
• Implant surgery
Dental implant surgery with two different kinds of implant surface (SLA and modified SLA)

Locations

Country	Name	City	State
Brazil	Dentistry School - University of São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

Bornstein MM, Wittneben JG, Brägger 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Loss of implant	If the implant has been not integrated to the bone!	4 months after surgery	Yes
Secondary	Implant stability (ISQ)	If the implant get successively and it has been integrated to bone. The stability will be evaluated at the surgery day (T0), one week after surgery (T1),after 2 weeks (T2), after 3 weeks (T3), after 5 weeks (T4), after 8 weeks (T5), after 12 weeks (T6) and after 16 weeks (T7).	Baseline, 1 to 16 weeks (4 months)	Yes