Evaluation of the Stability of Implants With Two Different Surface Treatments

Sponsor

University of Sao Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT02134743

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Implant Failed Pre-osseointegration Failure of Dental Implant	Procedure: Implant surgery	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Sep 1, 2016

Actual Study Completion Date :

Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Group 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 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)
Active Comparator: Control Group The patient of this group will receive implant with conventional surface, SLA (Sandblasted and Acid-Etched Surface).Intervention: implant placement.	Procedure: Implant surgery 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)

Arm

Intervention/Treatment

Experimental: Experimental Group

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

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)

Active Comparator: Control Group

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

Procedure: Implant surgery

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)

Outcome Measures

Primary Outcome Measures

Loss of implant [4 months after surgery]
If the implant has been not integrated to the bone!

Secondary Outcome Measures

Implant stability (ISQ) [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.