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Dental ImplantationSurfaceNCT03915509

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

A study testing Evaluation of the effect of surface properties on the stability of the different implants with resonance frequency analysis in people with Dental Implantation, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Dental Implantation
What is being tested?
Evaluation of the effect of surface properties on the stability of the different implants with resonance frequency analysis
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteTurkey (Türkiye)
Study dates
Apr 2011to Mar 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
  • -

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Aydın Adnan Menderes University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery

    Aydin

Other trials in Turkey (Türkiye)

About this study

Official title: 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).

Read the 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.

Being tested
Evaluation of the effect of surface properties on the stability of the different implants with resonance frequency analysis
Keywords
nanotopography, osseointegration, resonance frequency analysis.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Evaluation of the effect of surface properties on the stability of the different implants with resonance frequency analysisDevice

    Also called Lasak Impladent Implants (hydrophilic surface)

    Lasak Impladent Implants (sandblasted)

Study groups in NCT03915509
Study groupRoleWhat they receive
Bioactive groupExperimentalIn 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.
Receives: Device: Evaluation of the effect of surface properties on the stability of the different implants with resonance frequency analysis
Sandblasted groupActive comparatorIn 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.
Receives: Device: Evaluation of the effect of surface properties on the stability of the different implants with resonance frequency analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survey

    Defined after clinical and radiological examination.

    Measured: 3 months

Secondary outcomes (4)

  1. 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.

    Measured: 3 months

  2. 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.

    Measured: 3 months

  3. 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.

    Measured: 3 months

  4. 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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2019
  2. Study startApr 2011
  3. Primary completionMar 2012
  4. Study completionMar 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03915509
Sponsor's protocol ID
2011-31
Acronym
Surface
Status last verified
Apr 2019
First submitted
5 Apr 2019
Last updated
16 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

Questions about this trial

What is this clinical trial studying?

A study testing Evaluation of the effect of surface properties on the stability of the different implants with resonance frequency analysis in people with Dental Implantation, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survey (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03915509, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.

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