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

NCT03915509 | Completed

• 1 other identifier: 2011-31
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Dental Implantation

Keywords

nanotopography; osseointegration; resonance frequency analysis.

Outcome Measures

Primary Outcomes (1)

• Survey

  Defined after clinical and radiological examination.

  3 months

Secondary Outcomes (4)

• Surgery Implant Stability Quotient Measurement

  3 months

• Second Implant Stability Quotient Measurement

  3 months

• Third Implant Stability Quotient Measurement

  3 months

• Fourth Implant Stability Quotient Measurement

  3 months

Study Arms (2)

Bioactive group

EXPERIMENTAL

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

Sandblasted group

ACTIVE COMPARATOR

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

Interventions

Evaluation of the effect of surface properties on the stability of the different implants with resonance frequency analysis DEVICE

Lasak Impladent Implants (sandblasted)

Also known as: Lasak Impladent Implants (hydrophilic surface)

Bioactive group; Sandblasted group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

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

Aydin, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Interventions

Resonance Frequency Analysis

Intervention Hierarchy (Ancestors)

Prosthodontics; Dentistry

Study Officials

• Hanife ATAOGLU, Proffesor

  Selcuk University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Proffesor

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 16, 2019
• Study Start: April 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)