- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03915509
Evaluation Of The Effect Of Surface Properties On The Stabılıty Of The Different Implants (Surface)
April 11, 2019 updated by: Burcu Gürsoytrak, Aydin Adnan Menderes University
Evaluation Of The Effect Of Surface Properties On The Stabılıty Of The Different Implants With Resonance Frequency Analysis
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).
Study Overview
Status
Completed
Conditions
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Aydın, Turkey
- Aydın Adnan Menderes University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bioactive group
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.
|
Lasak Impladent Implants (sandblasted)
Other Names:
|
Active Comparator: Sandblasted group
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.
|
Lasak Impladent Implants (sandblasted)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survey
Time Frame: 3 months
|
Defined after clinical and radiological examination.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Surgery Implant Stability Quotient Measurement
Time Frame: 3 months
|
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
Time Frame: 3 months
|
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
Time Frame: 3 months
|
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
Time Frame: 3 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Hanife ATAOGLU, Proffesor, Selcuk University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Anil S, Al Dosari A. Impact of bone quality and implant type on the primary stability: an experimental study using bovine bone. J Oral Implantol. 2015;41:144-148. Balshi T.J., Wolfinger G.J.: Immediate loading of Branemark implants in edentulous mandibles: a preliminary report. Implant Dentistry., 1997; 6:83-8. Barewal R M, Oates T W, Meredith N, Cochran D L. Resonance frequency measurement of implant stability in vivo on implants with a sandblasted and acid-etched surface. Int J Oral Maxillofac İmplants, 2003; 18,:641-651. Bischof M, Nedir R, Szmukler-Moncler S, Bernard J P, Samson J. Implant stability measurement of delayed and immediatelly loaded implants during healing . A clinical RFA study with SLA ITI ımplants. Clin Oral Implants Res 2004;15: 529-539. Branemark PI. Introduction to osseointegration. In:Branemark PI, Zarb GA, Albrektsson T, eds. Tissue-Integrated Prostheses in Osseointegration in Clinical Dentistry. Chicago: Quintessence Pub Co Inc; 1985: 11-14. Cameron HU, Pilliar RM, Mac Nab I. The effect of movement on the bonding of porous metal to bone. J Biomed Mater Res. 1973;7:301-311. Cochran DL., Buser D. Bone response to sandblasted and acid-attacked titanium: Experimental and clinical studies In: Davies J E. Bone Engineering. Toronto: Em Squared; 2000:391-398. Davies JE. Mechanism of endosseous integration. Int J Prosthodont, 1998; 11: 391-401.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2011
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
April 5, 2019
First Submitted That Met QC Criteria
April 11, 2019
First Posted (Actual)
April 16, 2019
Study Record Updates
Last Update Posted (Actual)
April 16, 2019
Last Update Submitted That Met QC Criteria
April 11, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 2011-31 (CCRRC)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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