Evaluation Of The Effect Of Surface Properties On The Stabılıty Of The Different Implants

Study Overview
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Brief Summary
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This randomised clinical study aims to evaluate different surfaced implants (alkali-modified surfaced implants or sand-blasted surfaced implants) stability with resonance frequency analysis(RFA).

Detailed Description
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This is randomised controlled double blind study. Fourteen patients (8 women and 6 men;age 43.7 ± 8.56 years) who were attending the Oral and Maxillofacial Surgery Department and scheduled for implant placement surgery were included in this study. Dental implants were placed using one-stage protocol. After adminstration of local anesthesia (Ultracain DS; Aventis Pharmaceuticals, Istanbul, Turkey ), an incision was made on the alveolar ridge. A total of 50 implants (Impladent implants from the Lasak) were placed in the not site assignement mandibular premolar/molar sites according to the manufacturer's instructions. To prevent bias which implant to the right or left to make the decision investigators decided by envelope. The person making the measurement does not know which surface implant is made to the patient. An equal number of implants were applied simultaneously with different surfaces. The patient does not know where the implant is placed. All used implants were 3.7 width, 10mm. height and same design for standardization this study. Investigators obtained good primarly stability and placed a healing cap for 45 implants . 3 sandblasted and acid-and alkali-treated surface straight (bioactive)implants and 2 sandblasted surface straight implants were excluded in this study for bad primary stability. Investigators used to measure implant stability with Osstell ISQ ( Integration diagnostic AB, Savedalen, Sweden) for each implant at the time of surgery before flap closure, 2. week,6. week and 12. week postoperatively.This device was used in both buccolingual and mesiodistal direction. The Smartpegs (Integration Diagnostics AB, Göteborg, Sweden) were compressed and the measurements were performed by the same surgeon for standardization of the stability measurements. The measurements were taken twice in the buccolingual direction and twice in the mesiodistal direction. The arithmetic mean of the 2 measurements from each direction was regarded as the representative ISQ of that implant. In addition, each implant was clinically evaluated at all visits for mobility, pain, and signs of infection.

Official Title
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Evaluation Of The Effect Of Surface Properties On The Stabılıty Of The Different Implants With Resonance Frequency Analysis

Conditions
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Dental Implantation

Intervention / Treatment
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* Device: Evaluation of the effect of surface properties on the stability of the different implants with resonance frequency analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.A healthy medical condition (ASA 1 and ASA 2 according to the American Society of Anesthesiologists classification) 2.The ability to withstand the stress of dental implant surgery 3.The need for bilateral implant-supported rehabilitation in the mandibular premolar/molar area. - Exclusion Criteria: An active infection or severe inflammation in the areas intended for implant placement Metabolic bone disorder Uncontrolled diabetes Hematologic disorder Need for bone augmentation The smokers Drug users (anti-inflammatory agents, bisphosphonates) Pregnant patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bioactive group<br>In this study different surfaced implants applied patients who has bilateral edentulous mandibular molar region In one hemiarch, an alkali-modified surfaced implants were applied (bioactive group); in the other hemiarch, sand-blasted surfaced implants were applied (sand-blasted group). The implants were randomly selected. | Device: Evaluation of the effect of surface properties on the stability of the different implants with resonance frequency analysis<br>* Lasak Impladent Implants (sandblasted)<br>* Other names: Lasak Impladent Implants (hydrophilic surface);|
| Active Comparator: Sandblasted group<br>In this study different surfaced implants applied patients who has bilateral edentulous mandibular molar region In one hemiarch, an alkali-modified surfaced implants were applied (bioactive group); in the other hemiarch, sand-blasted surfaced implants were applied (sand-blasted group). The implants were randomly selected. | Device: Evaluation of the effect of surface properties on the stability of the different implants with resonance frequency analysis<br>* Lasak Impladent Implants (sandblasted)<br>* Other names: Lasak Impladent Implants (hydrophilic surface);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survey | Defined after clinical and radiological examination. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgery Implant Stability Quotient Measurement | After insertion of the implant, the primary stability measured implant stability quotient at the end of implantation with resonance frequency analysis.The implant stability quotient (range: 0-100) is a conversion of the resonance frequency value (3,500 to 8,500 Hz) . Generally, implant stability quotient values are interpreted as follows: i) >70: high stability, ii) 60-69: medium stability, and iii) <60: low stability. | 3 months | 
| Second Implant Stability Quotient Measurement | After insertion of the implant, the primary stability measured implant stability quotient after two weeks later.The implant stability quotient (range: 0-100) is a implantation with resonance frequency analysis.The implant stability quotient (range: 0-100) is a conversion of the resonance frequency value (3,500 to 8,500 Hz) . Generally, implant stability quotient values are interpreted as follows: i) >70: high stability, ii) 60-69: medium stability, and iii) <60: low stability. | 3 months | 
| Third Implant Stability Quotient Measurement | After insertion of the implant, the primary stability measured implant stability quotient after six weeks later.The implant stability quotient (range: 0-100) is a implantation with resonance frequency analysis.The implant stability quotient (range: 0-100) is a conversion of the resonance frequency value (3,500 to 8,500 Hz) . Generally, implant stability quotient values are interpreted as follows: i) >70: high stability, ii) 60-69: medium stability, and iii) <60: low stability. | 3 months | 
| Fourth Implant Stability Quotient Measurement | After insertion of the implant, the primary stability measured ISQ after twelve weeks later.The ISQ (range: 0-100) is a implantation with resonance frequency analysis.The ISQ (range: 0-100) is a conversion of the resonance frequency value (3,500 to 8,500 Hz) . Generally, ISQ values are interpreted as follows: i) >70: high stability, ii) 60-69: medium stability, and iii) <60: low stability. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nanotopography, osseointegration, resonance frequency analysis.