Skip to main content
OpenTrials
Completed

NCT Number: NCT02134743

Evaluation of the Stability of Implants With Two Different Surface Treatments

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dentistry School - University of São Paulo

São Paulo, 05508-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Implant Surgery

Procedure

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

Other names: Neodent Neoporos (SLA surface), Neodent Acqua (Modified SLA surface)

Primary outcomes

  1. Loss of implant

    Time frame: 4 months after surgery

    If the implant has been not integrated to the bone!

Secondary outcomes

  1. Implant stability (ISQ)

    Time frame: Baseline, 1 to 16 weeks (4 months)

    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).

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 9, 2014
Registry last updated
Sep 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.